Trial Outcomes & Findings for A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (NCT NCT02692716)

NCT ID: NCT02692716

Last Updated: 2022-07-20

Results Overview

Number of participants experiencing a first event of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3183 participants
• Primary outcome timeframe: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
• Results posted on: 2022-07-20

Participant Flow

The study was conducted at 214 sites in 21 countries: Algeria (4), Argentina (6), Brazil (1), Canada (7), Denmark (5), Germany (10), India (16), Israel (8), Italy (7), Malaysia (10), Mexico (6), Netherlands (5), Poland (5), Romania (8), South Africa (9), Spain (9), Taiwan (4), Thailand (7), Turkey (9) and United Kingdom (9), United Stated (69).

Data presented in "participant flow" is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Participant milestones

Measure	Oral Semaglutide Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Overall Study STARTED	1591	1592
Overall Study Full Analysis Set (FAS)	1591	1592
Overall Study Exposed	1591	1591
Overall Study COMPLETED	1586	1586
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Oral Semaglutide Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Overall Study Lost to Follow-up	2	5
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.	Total n=3183 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 7 • n=5 Participants	66 years STANDARD_DEVIATION 7 • n=7 Participants	66 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	507 Participants n=5 Participants	500 Participants n=7 Participants	1007 Participants n=5 Participants
Sex: Female, Male Male	1084 Participants n=5 Participants	1092 Participants n=7 Participants	2176 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	253 Participants n=5 Participants	261 Participants n=7 Participants	514 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1338 Participants n=5 Participants	1331 Participants n=7 Participants	2669 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	1148 Participants n=5 Participants	1152 Participants n=7 Participants	2300 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	89 Participants n=5 Participants	103 Participants n=7 Participants	192 Participants n=5 Participants
Race/Ethnicity, Customized Asian	324 Participants n=5 Participants	306 Participants n=7 Participants	630 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska native	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Baseline cardiovasular disease (CVD)/chronic kidney disease (CKD) risk details Established CVD and/or CKD, age ≥ 50 years	1350 Participants n=5 Participants	1345 Participants n=7 Participants	2695 Participants n=5 Participants
Baseline cardiovasular disease (CVD)/chronic kidney disease (CKD) risk details Evidence of CV risk factors, age ≥ 60 years	241 Participants n=5 Participants	247 Participants n=7 Participants	488 Participants n=5 Participants

PRIMARY outcome

Timeframe: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.

Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants.

Number of participants experiencing a first event of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke	61 Participants	76 Participants

SECONDARY outcome

Timeframe: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Participants experiencing first occurrence of an expanded composite CV endpoint [defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, UAP (unstable angina pectoris) requiring hospitalisation or heart failure requiring hospitalisation] are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure	83 Participants	100 Participants

SECONDARY outcome

Timeframe: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Participants experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalisation or heart failure requiring hospitalisation) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint Cardiovascular death	15 Participants	30 Participants
Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint Non-fatal myocardial infarction	37 Participants	31 Participants
Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint Non-fatal stroke	12 Participants	16 Participants
Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint Unstable angina requiring hospitalisation	11 Participants	7 Participants
Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint Heart failure requiring hospitalisation	21 Participants	24 Participants

SECONDARY outcome

Timeframe: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Participants experiencing first occurrence of a composite CV endpoint (defined as all-cause death, non-fatal myocardial infarction or nonfatal stroke) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke	69 Participants	89 Participants

SECONDARY outcome

Timeframe: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Number of participants experiencing a first event of a fatal or non-fatal myocardial infarction are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction	37 Participants	35 Participants

SECONDARY outcome

Timeframe: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Number of participants experiencing a first event of a fatal or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke	13 Participants	17 Participants

SECONDARY outcome

Timeframe: Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period.

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Number of all-cause deaths in the study are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Time From Randomisation to All-cause Death	23 Participants	45 Participants

SECONDARY outcome

Timeframe: Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Number of participants who permanently discontinued trial product in ths study are presented. Results are based on the on-treatment observation period which starts at the date of first dose on trial product; ends on last date on trial product +38 days (ascertainment window).

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Time to First AE Leading to Permanent Trial Product Discontinuation	184 Participants	104 Participants

SECONDARY outcome

Timeframe: Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Number of serious adverse events were recorded from week 0 to week 87 in the study. Results are based on the on-treatment observation period which started at the date of first dose on trial product and ended on last date on trial product +38 days (ascertainment window).

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Number of Serious Adverse Events	545 Events	618 Events

SECONDARY outcome

Timeframe: Week -3, End of treatment

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.

Participants with eye examination findings, normal, abnormal non clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -3) and end of treatment visit (week 83) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1591 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1592 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Change in Eye Examination Category Left eye fundoscopy (week -3): Normal	848 Participants	843 Participants
Change in Eye Examination Category Left eye fundoscopy (week -3): Abnormal NCS	657 Participants	673 Participants
Change in Eye Examination Category Left eye fundoscopy (week -3): Abnormal CS	86 Participants	74 Participants
Change in Eye Examination Category Right eye fundoscopy (week -3): Normal	845 Participants	858 Participants
Change in Eye Examination Category Right eye fundoscopy (week -3): Abnormal NCS	659 Participants	661 Participants
Change in Eye Examination Category Right eye fundoscopy (week -3): Abnormal CS	86 Participants	72 Participants
Change in Eye Examination Category Left eye fundoscopy (EOT): Normal	783 Participants	790 Participants
Change in Eye Examination Category Left eye fundoscopy (EOT): Abnormal NCS	599 Participants	597 Participants
Change in Eye Examination Category Left eye fundoscopy (EOT): Abnormal CS	83 Participants	62 Participants
Change in Eye Examination Category Right eye fundoscopy (EOT): Normal	780 Participants	787 Participants
Change in Eye Examination Category Right eye fundoscopy (EOT): Abnormal NCS	601 Participants	599 Participants
Change in Eye Examination Category Right eye fundoscopy (EOT): Abnormal CS	81 Participants	64 Participants

SECONDARY outcome

Timeframe: Week 0, End of treatment

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in pulse rate measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).

Outcome measures

Measure	Oral Semaglutide n=1345 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1411 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Change in Pulse Rate	4 Beats/minute Standard Deviation 11	-0 Beats/minute Standard Deviation 11

SECONDARY outcome

Timeframe: Week 0, End of treatment

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in systolic and diastolic blood pressure measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).

Outcome measures

Measure	Oral Semaglutide n=1345 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1411 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Change in Systolic and Diastolic Blood Pressure Diastolic blood pressure	-1 mmHg Standard Deviation 11	-2 mmHg Standard Deviation 10
Change in Systolic and Diastolic Blood Pressure Systolic blood pressure	-5 mmHg Standard Deviation 18	-2 mmHg Standard Deviation 18

SECONDARY outcome

Timeframe: Week 0, End of treatment

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in HbA1c measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1489 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1473 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Change in Glycosylated Haemoglobin (HbA1c)	-1.0 Percentage of HbA1c Standard Deviation 1.4	-0.3 Percentage of HbA1c Standard Deviation 1.3

SECONDARY outcome

Timeframe: Week 0, End of treatment

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in body weight measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1510 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1493 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Change in Body Weight	-4.2 Kg Standard Deviation 5.7	-0.8 Kg Standard Deviation 4.5

SECONDARY outcome

Timeframe: Week 0, End of treatment

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in total cholesterol (mmol/L) at the end of treatment (week 83) visit is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1472 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1469 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Change in Total Cholesterol - Ratio to Baseline	0.97 Ratio of total cholesterol Geometric Coefficient of Variation 21.9	0.98 Ratio of total cholesterol Geometric Coefficient of Variation 21.1

SECONDARY outcome

Timeframe: Week 0, End of treatment

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in LDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1466 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1467 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Change in LDL-cholesterol - Ratio to Baseline	0.96 Ratio of LDL-cholesterol Geometric Coefficient of Variation 36.6	0.97 Ratio of LDL-cholesterol Geometric Coefficient of Variation 34.5

SECONDARY outcome

Timeframe: Week 0, End of treatment

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in HDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1468 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1467 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Change in HDL-cholesterol - Ratio to Baseline	1.05 Ratio of HDL-cholesterol Geometric Coefficient of Variation 16.9	1.02 Ratio of HDL-cholesterol Geometric Coefficient of Variation 15.9

SECONDARY outcome

Timeframe: Week 0, End of treatment

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in triglycerides (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.

Outcome measures

Measure	Oral Semaglutide n=1468 Participants Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1467 Participants Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Change in Triglycerides - Ratio to Baseline	0.92 Ratio of triglycerides Geometric Coefficient of Variation 41.8	0.97 Ratio of triglycerides Geometric Coefficient of Variation 39.8

Adverse Events

Oral Semaglutide

Serious events: 301 serious events

Other events: 0 other events

Deaths: 23 deaths

Placebo

Serious events: 358 serious events

Other events: 0 other events

Deaths: 45 deaths

Serious adverse events

Measure	Oral Semaglutide n=1591 participants at risk Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.	Placebo n=1591 participants at risk Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
Gastrointestinal disorders Abdominal pain	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Abdominal pain upper	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Abscess limb	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Accidental overdose	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Acute coronary syndrome	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Acute kidney injury	0.82% 13/1591 • Number of events 14 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.88% 14/1591 • Number of events 18 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Acute left ventricular failure	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Acute myocardial infarction	1.3% 21/1591 • Number of events 25 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	1.4% 22/1591 • Number of events 25 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Acute prerenal failure	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Psychiatric disorders Alcoholism	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Blood and lymphatic system disorders Anaemia	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Anal abscess	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Immune system disorders Anaphylactic reaction	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Angina pectoris	0.50% 8/1591 • Number of events 9 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.44% 7/1591 • Number of events 7 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Angina unstable	1.2% 19/1591 • Number of events 20 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.94% 15/1591 • Number of events 18 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Ankle fracture	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Aortic aneurysm	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Aortic aneurysm repair	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Aortic dissection	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Aortic stenosis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Arrhythmia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Arteriosclerosis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Arteriosclerosis coronary artery	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Arteriospasm coronary	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Arthritis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Arthropathy	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Aspiration	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Asthenia	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Atrial fibrillation	0.38% 6/1591 • Number of events 8 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.88% 14/1591 • Number of events 14 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Atrial flutter	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Atrioventricular block complete	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Atrioventricular block first degree	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Atrioventricular block second degree	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Azotaemia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Bile duct stone	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Biliary fistula	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Biliary sepsis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Psychiatric disorders Bipolar disorder	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Bladder prolapse	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Investigations Blood creatinine increased	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Investigations Blood potassium increased	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Bradycardia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Brain contusion	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Bronchitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Bursitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Campylobacter gastroenteritis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Carbuncle	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the appendix	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiac arrest	0.31% 5/1591 • Number of events 6 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiac failure	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.44% 7/1591 • Number of events 8 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiac failure acute	0.13% 2/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiac failure chronic	0.31% 5/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.50% 8/1591 • Number of events 9 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiac failure congestive	0.57% 9/1591 • Number of events 12 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.57% 9/1591 • Number of events 11 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiac flutter	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Cardiac pacemaker insertion	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardio-respiratory arrest	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiogenic shock	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiomyopathy	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiopulmonary failure	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Cardiorenal syndrome	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Carotid artery occlusion	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Carotid artery stenosis	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.25% 4/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Eye disorders Cataract	0.50% 8/1591 • Number of events 8 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.31% 5/1591 • Number of events 6 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Cataract operation	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Cellulitis	0.57% 9/1591 • Number of events 9 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.44% 7/1591 • Number of events 7 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Cerebellar infarction	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Cerebral infarction	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Cerebral ischaemia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Cerebrovascular accident	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Chest pain	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Cholangitis acute	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Cholecystectomy	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Cholecystitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Cholecystitis acute	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Cholecystitis chronic	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Cholecystitis infective	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Cholelithiasis	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Chronic kidney disease	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.31% 5/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.50% 8/1591 • Number of events 11 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Investigations Clostridium test positive	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Colitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Colitis ischaemic	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Psychiatric disorders Confusional state	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Constipation	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Coronary artery disease	0.57% 9/1591 • Number of events 9 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.82% 13/1591 • Number of events 13 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Coronary artery stenosis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Coronary artery thrombosis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Death	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Deep vein thrombosis	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Degenerative aortic valve disease	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Dehydration	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Dementia with Lewy bodies	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Psychiatric disorders Depression	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Skin and subcutaneous tissue disorders Dermatomyositis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Product Issues Device malfunction	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Device related infection	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Skin and subcutaneous tissue disorders Diabetic foot	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.38% 6/1591 • Number of events 7 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Diabetic foot infection	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Diabetic gangrene	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Diabetic neuropathy	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Diarrhoea	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Escherichia pyelonephritis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Diverticulitis	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Dizziness	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Drowning	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Psychiatric disorders Drug dependence	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Dyspepsia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.06% 1/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Dyspraxia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Ear injury	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Investigations Ejection fraction decreased	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Empyema	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Encephalopathy	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Endocarditis bacterial	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Erysipelas	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Fall	0.31% 5/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.69% 11/1591 • Number of events 11 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Fatigue	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Femur fracture	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Finger repair operation	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Folliculitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Foreign body in ear	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Gallbladder empyema	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Gangrene	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Gastric bypass	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Gastric ulcer	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Gastritis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Gastroduodenitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Gastroenteritis	0.31% 5/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.31% 5/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Gastroenteritis viral	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Gastrointestinal polyp haemorrhage	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Glaucoma surgery	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Graft haemorrhage	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Haematochezia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Haematuria	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Haemorrhoids	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Headache	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Hemiparesis	0.13% 2/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Hepatic cirrhosis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Investigations Hepatic enzyme increased	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Hepatic steatosis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Hepatitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Hernia pain	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Herpes zoster	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Hip arthroplasty	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Hip fracture	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Hydronephrosis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Hyperglycaemia	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Hyperkalaemia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Hypertension	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Hypertensive crisis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Hypertensive emergency	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Hypertensive heart disease	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Endocrine disorders Hyperthyroidism	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Hypoaesthesia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Hypoglycaemia	0.31% 5/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Hypoglycaemic seizure	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Hypoglycaemic unconsciousness	0.57% 9/1591 • Number of events 11 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.38% 6/1591 • Number of events 8 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Hypokalaemia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Hyponatraemia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Hypotension	0.31% 5/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders IgA nephropathy	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Implantable defibrillator insertion	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Infective tenosynovitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Influenza	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Inguinal hernia	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Injection site abscess	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Injury corneal	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Intervertebral discitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Intestinal mass	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Blood and lymphatic system disorders Iron deficiency anaemia	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Ischaemic cardiomyopathy	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Ischaemic stroke	0.57% 9/1591 • Number of events 9 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.69% 11/1591 • Number of events 12 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Joint arthroplasty	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Joint dislocation	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Joint injury	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Knee arthroplasty	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Laceration	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Lactic acidosis	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Lacunar infarction	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Lacunar stroke	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Large intestine polyp	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Metabolism and nutrition disorders Latent autoimmune diabetes in adults	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Left ventricular failure	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Blood and lymphatic system disorders Leukocytosis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Light chain disease	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Limb injury	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Hepatobiliary disorders Liver disorder	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Lower respiratory tract infection	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Ludwig angina	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Lumbosacral plexopathy	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Malignant hypertension	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Psychiatric disorders Mania	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Meningitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Psychiatric disorders Mental status changes	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Migraine	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Mitral valve incompetence	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Murine typhus	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Myasthenia gravis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Myelitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Myocardial infarction	0.69% 11/1591 • Number of events 11 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.57% 9/1591 • Number of events 9 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Myocardial ischaemia	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Myocarditis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Nausea	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Neck pain	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Nephrolithiasis	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Neuritis	0.06% 1/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Neurotoxicity	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Non-cardiac chest pain	0.57% 9/1591 • Number of events 11 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.44% 7/1591 • Number of events 9 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Oedema peripheral	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Oesophageal haemorrhage	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Oesophagitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Oesophagitis ulcerative	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Open globe injury	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Optic neuritis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Oral infection	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Orthostatic hypotension	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.38% 6/1591 • Number of events 6 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.63% 10/1591 • Number of events 10 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Osteomyelitis	0.31% 5/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour metastatic	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Pancreatitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Parkinsonism	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Patella fracture	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Pathological fracture	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Pelvic fracture	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile squamous cell carcinoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Periorbital cellulitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Peripheral arterial occlusive disease	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.44% 7/1591 • Number of events 7 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Peripheral artery dissection	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Peripheral artery occlusion	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Peripheral artery stenosis	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Peripheral ischaemia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Peripheral swelling	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Peripheral vascular disorder	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.06% 1/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Pneumonia	0.75% 12/1591 • Number of events 13 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	1.3% 21/1591 • Number of events 21 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Pneumonia acinetobacter	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Pneumonia escherichia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Pneumonia influenzal	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Pneumonia klebsiella	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Pneumonia streptococcal	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Post procedural cellulitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Post procedural haematuria	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Post procedural infection	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Post procedural pneumonia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Postoperative wound infection	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Prinzmetal angina	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage III	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage IV	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Pulmonary tuberculosis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Pulseless electrical activity	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Pyelonephritis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Pyelonephritis acute	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Pyrexia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Radius fracture	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Rectal abscess	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Renal failure	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Renal impairment	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Eye disorders Retinal tear	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Eye disorders Retinopathy proliferative	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Rib fracture	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Road traffic accident	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Salivary gland calculus	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Seizure	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Sepsis	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.38% 6/1591 • Number of events 6 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Septic shock	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Sialoadenitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Sinus node dysfunction	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Sinusitis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Skin and subcutaneous tissue disorders Skin ulcer	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Spinal compression fracture	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Spinal fusion surgery	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Blood and lymphatic system disorders Splenic haemorrhage	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Spondylitic myelopathy	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Subdural haematoma	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Subdural haematoma evacuation	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Sudden cardiac death	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Syncope	0.44% 7/1591 • Number of events 7 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Systemic inflammatory response syndrome	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Tachycardia	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Tendon injury	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Vascular disorders Thrombosis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Endocrine disorders Thyroid mass	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Tinea pedis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Tonsillitis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Transient ischaemic attack	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.38% 6/1591 • Number of events 6 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Transurethral prostatectomy	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Surgical and medical procedures Trapeziectomy	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Musculoskeletal and connective tissue disorders Trigger finger	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Investigations Troponin increased	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Umbilical hernia	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Upper limb fracture	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Upper respiratory tract infection	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Upper respiratory tract infection bacterial	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Ureterolithiasis	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Urethral stenosis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Renal and urinary disorders Urinary incontinence	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Urinary tract infection	0.19% 3/1591 • Number of events 3 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.31% 5/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Urosepsis	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.19% 3/1591 • Number of events 5 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders VIth nerve paralysis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Nervous system disorders Vascular dementia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.13% 2/1591 • Number of events 2 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
General disorders Vascular stent restenosis	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Skin and subcutaneous tissue disorders Vasculitic ulcer	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Ventricular fibrillation	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Cardiac disorders Ventricular tachycardia	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Ear and labyrinth disorders Vertigo	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Gastrointestinal disorders Vomiting	0.25% 4/1591 • Number of events 4 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.
Infections and infestations Wound sepsis	0.06% 1/1591 • Number of events 1 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.	0.00% 0/1591 • Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

Results disclosure agreements

• Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
• Publication restrictions are in place

Restriction type: OTHER