Trial Outcomes & Findings for Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea (NCT NCT02471404)

NCT ID: NCT02471404

Last Updated: 2019-03-26

Results Overview

Change in HbA1c from baseline (week 0) to week 52.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 939 participants
• Primary outcome timeframe: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
• Results posted on: 2019-03-26

Participant Flow

Participant milestones

Measure	Dapagliflozin 10mg Dapagliflozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg Glimepiride 1mg/2mg/4mg + Metformin
Overall Study STARTED	314	312	313
Overall Study COMPLETED	281	298	288
Overall Study NOT COMPLETED	33	14	25

Reasons for withdrawal

Measure	Dapagliflozin 10mg Dapagliflozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg Glimepiride 1mg/2mg/4mg + Metformin
Overall Study Adverse Event	7	1	2
Overall Study Developed Study Withdrawal Criteria	4	1	2
Overall Study Failure to Meet Randomization Criteria	2	0	1
Overall Study Lost to Follow-up	1	1	3
Overall Study Protocol Violation	1	0	0
Overall Study Withdrawal by Subject	8	4	5
Overall Study Other reasons not specified	10	7	12

Baseline Characteristics

Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea

Baseline characteristics by cohort

Measure	Dapagliflozin 10mg n=314 Participants Dapagliflozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg n=312 Participants Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg n=313 Participants Glimepiride 1mg/2mg/4mg + Metformin	Total n=939 Participants Total of all reporting groups
Age, Continuous	57.4 Years STANDARD_DEVIATION 9.36 • n=5 Participants	59.2 Years STANDARD_DEVIATION 7.87 • n=7 Participants	58.6 Years STANDARD_DEVIATION 8.38 • n=5 Participants	58.4 Years STANDARD_DEVIATION 8.58 • n=4 Participants
Age, Customized <65	232 Participants n=5 Participants	226 Participants n=7 Participants	226 Participants n=5 Participants	684 Participants n=4 Participants
Age, Customized >=65-<75	81 Participants n=5 Participants	86 Participants n=7 Participants	85 Participants n=5 Participants	252 Participants n=4 Participants
Age, Customized >=75	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	122 Participants n=7 Participants	105 Participants n=5 Participants	339 Participants n=4 Participants
Sex: Female, Male Male	202 Participants n=5 Participants	190 Participants n=7 Participants	208 Participants n=5 Participants	600 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Black Or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized White	311 Participants n=5 Participants	307 Participants n=7 Participants	311 Participants n=5 Participants	929 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

Population: Full Analysis Set

Change in HbA1c from baseline (week 0) to week 52.

Outcome measures

Measure	Dapaglifozin 10mg n=311 Participants Dapaglifozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg n=312 Participants Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg n=309 Participants Glimepiride 1mg/2mg/4mg + Metformin
Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52	-0.82 HbA1c % Standard Error 0.049	-1.2 HbA1c % Standard Error 0.046	-0.99 HbA1c % Standard Error 0.048

SECONDARY outcome

Timeframe: Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

Population: Full Analysis Set

Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose <=50 mg/dL) during the double-blind treatment period

Outcome measures

Measure	Dapaglifozin 10mg n=311 Participants Dapaglifozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg n=312 Participants Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg n=309 Participants Glimepiride 1mg/2mg/4mg + Metformin
Patients With at Least One Episode of Confirmed Hypoglycaemia	0 Percentage of participants	0.32 Percentage of participants	4.21 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

Change in body weight from baseline (week 0) to week 52

Outcome measures

Measure	Dapaglifozin 10mg n=311 Participants Dapaglifozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg n=312 Participants Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg n=309 Participants Glimepiride 1mg/2mg/4mg + Metformin
Change in Total Body Weight From Baseline at Week 52	-3.54 Weight (kg) Standard Error 0.231	-3.15 Weight (kg) Standard Error 0.219	1.76 Weight (kg) Standard Error 0.224

SECONDARY outcome

Timeframe: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

Population: Full Analysis Set

Change in FPG from baseline (week 0) to week 52

Outcome measures

Measure	Dapaglifozin 10mg n=311 Participants Dapaglifozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg n=312 Participants Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg n=309 Participants Glimepiride 1mg/2mg/4mg + Metformin
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52	-1.62 FPG (mmol/L) Standard Error 0.106	-2.08 FPG (mmol/L) Standard Error 0.100	-1.49 FPG (mmol/L) Standard Error 0.105

SECONDARY outcome

Timeframe: Over the 52 week treatment period

The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period

Outcome measures

Measure	Dapaglifozin 10mg n=311 Participants Dapaglifozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg n=312 Participants Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg n=309 Participants Glimepiride 1mg/2mg/4mg + Metformin
Time to Rescue	NA Weeks Median time to rescue is not estimable due to the fact that less than 50% of patients had required rescue by the end of the treatment period (52 weeks). Cpnsequently the CI is not estimable either.	NA Weeks Median time to rescue is not estimable due to the fact that less than 50% of patients had required rescue by the end of the treatment period (52 weeks). Cpnsequently the CI is not estimable either.	NA Weeks Median time to rescue is not estimable due to the fact that less than 50% of patients had required rescue by the end of the treatment period (52 weeks). Cpnsequently the CI is not estimable either.

SECONDARY outcome

Timeframe: Over the 52 week treatment period

Number (%) of patients rescued.

Outcome measures

Measure	Dapaglifozin 10mg n=311 Participants Dapaglifozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg n=312 Participants Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg n=309 Participants Glimepiride 1mg/2mg/4mg + Metformin
Number of Patients Rescued	18.6 Percentage of participants	8.3 Percentage of participants	21.4 Percentage of participants

Adverse Events

Dapagliflozin 10mg

Serious events: 39 serious events

Other events: 29 other events

Deaths: 0 deaths

Saxagliptin 5mg and Dapagliflozin 10mg

Serious events: 22 serious events

Other events: 31 other events

Deaths: 0 deaths

Glimepiride 1mg/2mg/4mg

Serious events: 35 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dapagliflozin 10mg n=313 participants at risk Dapagliflozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg n=312 participants at risk Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg n=312 participants at risk Glimepiride 1mg/2mg/4mg + Metformin
Cardiac disorders Acute coronary syndrome	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Cardiac disorders Acute myocardial infarction	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Cardiac disorders Angina pectoris	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.64% 2/312 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Cardiac disorders Bradyarrhythmia	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Cardiac disorders Coronary artery disease	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.96% 3/312 • Number of events 3 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.64% 2/312 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Cardiac disorders Coronary artery occlusion	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Cardiac disorders Myocardial ischaemia	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Endocrine disorders Basedow's disease	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Endocrine disorders Goitre	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Endocrine disorders Thyroid haemorrhage	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Eye disorders Vitritis	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Gastrointestinal disorders Anal fistula	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Gastrointestinal disorders Gastric ulcer	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Gastrointestinal disorders Gastritis	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Gastrointestinal disorders Vomiting	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.64% 2/312 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Hepatobiliary disorders Cholelithiasis	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Abscess neck	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Appendicitis	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Endocarditis	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Erysipelas	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Gastroenteritis clostridial	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Micrococcus infection	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Pneumonia	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Reiter's syndrome	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Scrotal abscess	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Infections and infestations Urinary tract infection	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Injury, poisoning and procedural complications Brain contusion	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Injury, poisoning and procedural complications Respiratory fume inhalation disorder	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Musculoskeletal and connective tissue disorders Back pain	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.64% 2/313 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.64% 2/312 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.64% 2/312 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Musculoskeletal and connective tissue disorders Muscle rigidity	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.64% 2/312 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma recurrent	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Brain stem infarction	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Cerebral ischaemia	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Cerebrovascular accident	0.64% 2/313 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Essential tremor	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Headache	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Restless legs syndrome	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Seizure	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Syncope	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Transient ischaemic attack	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Psychiatric disorders Depression	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Psychiatric disorders Somatic symptom disorder	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Renal and urinary disorders Bladder prolapse	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Renal and urinary disorders Nephrolithiasis	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Renal and urinary disorders Renal impairment	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Renal and urinary disorders Ureterolithiasis	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Renal and urinary disorders Urethral stenosis	0.64% 2/313 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Renal and urinary disorders Urinary incontinence	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Reproductive system and breast disorders Acquired phimosis	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.64% 2/312 • Number of events 2 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Skin and subcutaneous tissue disorders Diabetic foot	0.32% 1/313 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Vascular disorders Hypertensive crisis	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.00% 0/312 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/313 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	0.32% 1/312 • Number of events 1 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.

Other adverse events

Measure	Dapagliflozin 10mg n=313 participants at risk Dapagliflozin 10mg + Metformin	Saxagliptin 5mg and Dapagliflozin 10mg n=312 participants at risk Saxagliptin 5mg and Dapagliflozin 10mg + Metformin	Glimepiride 1mg/2mg/4mg n=312 participants at risk Glimepiride 1mg/2mg/4mg + Metformin
Infections and infestations Nasopharyngitis	9.3% 29/313 • Number of events 40 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	9.9% 31/312 • Number of events 39 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.	11.9% 37/312 • Number of events 49 • Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent. Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.

Additional Information

Eva Johnsson, MD, PhD

AstraZeneca

Phone: +46 (0)31776 24 84

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place