Trial Outcomes & Findings for Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment (NCT NCT02827708)

Last Updated: 2020-02-17

Results Overview

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

324 participants

Primary outcome timeframe

Week 0, week 26

Results posted on

2020-02-17

Participant Flow

The trial was conducted in 8 countries (107 sites screened/88 randomised subjects), as follows: Denmark: 7/4; Finland: 7/7; Israel: 7/6; Poland: 2/2; Russian Federation: 19/18; Sweden: 6/4; United Kingdom: 9/7; United States (US):50/40. In addition, 10 sites in the US were approved by the institutional review board, but didn't randomise any subject

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

Participant milestones

Participant milestones
Measure	Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Overall Study STARTED	163	161
Overall Study Full Analysis Set (FAS)	163	161
Overall Study Safety Analysis Set (SAS)	163	161
Overall Study COMPLETED	158	156
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Overall Study Lost to Follow-up	3	1
Overall Study Withdrawal by Subject	1	2
Overall Study Death	1	2

Baseline Characteristics

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.	Total n=324 Participants Total of all reporting groups
Age, Continuous	71 Years STANDARD_DEVIATION 8 • n=5 Participants	70 Years STANDARD_DEVIATION 8 • n=7 Participants	70 Years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	88 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	73 Participants n=7 Participants	156 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	156 Participants n=5 Participants	147 Participants n=7 Participants	303 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	158 Participants n=5 Participants	152 Participants n=7 Participants	310 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Glycosylated haemoglobin (HbA1c)	8.0 Percentage of HbA1c STANDARD_DEVIATION 0.7 • n=5 Participants	7.9 Percentage of HbA1c STANDARD_DEVIATION 0.7 • n=7 Participants	8.0 Percentage of HbA1c STANDARD_DEVIATION 0.7 • n=5 Participants

PRIMARY outcome

Timeframe: Week 0, week 26

Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in HbA1c In-trial	-1.1 Percentage of HbA1c Standard Deviation 1.0	-0.2 Percentage of HbA1c Standard Deviation 0.9
Change in HbA1c On-treatment without rescue medication	-1.2 Percentage of HbA1c Standard Deviation 0.9	-0.1 Percentage of HbA1c Standard Deviation 0.9

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Body Weight (kg) In-trial	-3.5 kg Standard Deviation 3.8	-0.9 kg Standard Deviation 2.9
Change in Body Weight (kg) On-treatment without rescue medication	-3.9 kg Standard Deviation 3.6	-0.9 kg Standard Deviation 2.9

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=151 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=151 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in FPG	-1.58 mmol/L Standard Deviation 2.96	-0.34 mmol/L Standard Deviation 3.03

SECONDARY outcome

Timeframe: Week 0, week 26

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

Relative change from baseline (week 0) in body weight (kg) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=154 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=155 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Body Weight (%)	-3.75 Percentage change Standard Deviation 4.10	-0.92 Percentage change Standard Deviation 3.13

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=154 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=155 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in BMI	-1.2 kg/m^2 Standard Deviation 1.3	-0.3 kg/m^2 Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in waist circumference was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=152 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=154 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Waist Circumference	-2.8 Centimetre (cm) Standard Deviation 4.9	-0.7 Centimetre (cm) Standard Deviation 3.8

SECONDARY outcome

Timeframe: Week 26

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

Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=154 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=155 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol), ADA Target (Yes/no) Yes	89 Participants	35 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol), ADA Target (Yes/no) No	65 Participants	120 Participants

SECONDARY outcome

Timeframe: Week 26

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

Participants who achieved HbA1c ≤6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no), was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=154 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=155 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no) Yes	60 Participants	12 Participants
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no) No	94 Participants	143 Participants

SECONDARY outcome

Timeframe: Week 26

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

Participants who achieved weight loss ≥5% of their baseline body weight (yes/no) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=154 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=155 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Participants Who Achieve Weight Loss ≥5% (Yes/no) Yes	55 Participants	15 Participants
Participants Who Achieve Weight Loss ≥5% (Yes/no) No	99 Participants	140 Participants

SECONDARY outcome

Timeframe: Week 26

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

Participants who achieved weight loss of ≥10% of their baseline body weight (yes/no) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=154 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=155 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Participants Who Achieve Weight Loss ≥10% (Yes/no) Yes	13 Participants	0 Participants
Participants Who Achieve Weight Loss ≥10% (Yes/no) No	141 Participants	155 Participants

SECONDARY outcome

Timeframe: Week 26

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

Participants who achieved HbA1c \<7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) was evaluated at week 26. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=154 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=155 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) Yes	78 Participants	27 Participants
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) No	76 Participants	128 Participants

SECONDARY outcome

Timeframe: Week 26

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

Participants who achieved HbA1c reduction ≥1% and weight loss of ≥3% (yes/no) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=154 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=155 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) Yes	60 Participants	12 Participants
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) No	94 Participants	143 Participants

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in total cholesterol (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=148 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=153 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Total Cholesterol (Ratio to Baseline)	0.97 Ratio of total cholesterol Geometric Coefficient of Variation 20.1	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 23.0

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=148 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=152 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in LDL Cholesterol (Ratio to Baseline)	0.97 Ratio of LDL cholesterol Geometric Coefficient of Variation 32.7	1.00 Ratio of LDL cholesterol Geometric Coefficient of Variation 38.2

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=148 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=153 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in HDL Cholesterol (Ratio to Baseline)	1.02 Ratio of HDL cholesterol Geometric Coefficient of Variation 17.5	1.02 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.4

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in triglycerides (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=148 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=153 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Triglycerides (Ratio to Baseline)	0.87 Ratio of triglycerides Geometric Coefficient of Variation 37.7	0.95 Ratio of triglycerides Geometric Coefficient of Variation 37.1

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in C-reactive protein (CRP) (mg/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=152 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=154 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in CRP (Ratio to Baseline)	0.86 Ratio of CRP Geometric Coefficient of Variation 135.1	1.00 Ratio of CRP Geometric Coefficient of Variation 136.0

SECONDARY outcome

Timeframe: Weeks 0-26

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

Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period, from week 0 to week 26. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 26), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Time to Additional Anti-diabetic Medication	12 Participants	21 Participants

SECONDARY outcome

Timeframe: Weeks 0-26

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

Presented results are the number of participants who had taken rescue medication anytime during the period, from week 0 to week 26. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Time to Rescue Medication	7 Participants	16 Participants

SECONDARY outcome

Timeframe: Weeks 0-31

Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Number of TEAEs	463 Events	331 Events

SECONDARY outcome

Timeframe: Weeks 0-31

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.

Treatment emergent severe or BG-confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the first dose of trial product until last dose of trial product were considered treatment -emergent. Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes	17 Episodes	3 Episodes

SECONDARY outcome

Timeframe: Weeks 0-31

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.

Number of participants with treatment emergent severe or BG-confirmed symptomatic hypoglycaemic episodes was recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the first dose of trial product until last dose of trial product were considered treatment -emergent. Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)	9 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in amylase (units/litre (U/L)) at week 26 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=129 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=140 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Amylase (Ratio to Baseline)	1.09 Ratio of amylase Geometric Coefficient of Variation 22.9	0.99 Ratio of amylase Geometric Coefficient of Variation 25.6

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in lipase (U/L) at week 26 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=129 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=140 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Lipase (Ratio to Baseline)	1.16 Ratio of lipase Geometric Coefficient of Variation 57.6	0.94 Ratio of lipase Geometric Coefficient of Variation 52.5

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in pulse rate was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=133 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=141 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Pulse Rate	1 Beats/minute Standard Deviation 9	-1 Beats/minute Standard Deviation 9

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=133 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=141 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Systolic blood pressure	-8 mmHg Standard Deviation 14	0 mmHg Standard Deviation 13
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Diastolic blood pressure	-3 mmHg Standard Deviation 9	0 mmHg Standard Deviation 8

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in urinary albumin to creatinine ratio (mg/mmol) at week 26 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=131 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=136 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Urinary Albumin to Creatinine Ratio (Ratio to Baseline)	0.86 Ratio Geometric Coefficient of Variation 119.7	1.19 Ratio Geometric Coefficient of Variation 145.4

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at week 26. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in ECG Normal (week 0) to normal (week 26)	38 Participants	39 Participants
Change in ECG Normal (week 0) to abnormal NCS (week 26)	13 Participants	9 Participants
Change in ECG Normal (week 0) to abnormal CS (week 26)	1 Participants	0 Participants
Change in ECG Abnormal (week 0) NCS to normal (week 26)	12 Participants	13 Participants
Change in ECG Abnormal (week 0) NCS to abnormal NCS (week 26)	84 Participants	88 Participants
Change in ECG Abnormal (week 0) NCS to abnormal CS (week 26)	1 Participants	2 Participants
Change in ECG Abnormal (week 0) CS to normal (week 26)	0 Participants	0 Participants
Change in ECG Abnormal (week 0) CS to abnormal NCS (week 26)	1 Participants	0 Participants
Change in ECG Abnormal (week 0) CS to abnormal CS (week 26)	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Week -2, week 26

Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (week \[wk\] -2) and wk 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Nervous system (central and peripheral); 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head (ears, eyes, nose), throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Physical Examination 1) Cardiovascular system (wk -2): Normal	107 Participants	103 Participants
Change in Physical Examination 1) Cardiovascular system (wk -2): Abnormal NCS	50 Participants	55 Participants
Change in Physical Examination 1) Cardiovascular system (wk -2): Abnormal CS	6 Participants	3 Participants
Change in Physical Examination 1) Cardiovascular system (wk 26): Normal	101 Participants	104 Participants
Change in Physical Examination 1) Cardiovascular system (wk 26): Abnormal NCS	48 Participants	47 Participants
Change in Physical Examination 1) Cardiovascular system (wk 26): Abnormal CS	6 Participants	3 Participants
Change in Physical Examination 2) Nervous system (wk -2): Normal	114 Participants	116 Participants
Change in Physical Examination 2) Nervous system (wk -2): Abnormal NCS	41 Participants	45 Participants
Change in Physical Examination 2) Nervous system (wk -2): Abnormal CS	8 Participants	0 Participants
Change in Physical Examination 2) Nervous system (wk 26): Normal	109 Participants	115 Participants
Change in Physical Examination 2) Nervous system (wk 26): Abnormal NCS	40 Participants	39 Participants
Change in Physical Examination 2) Nervous system (wk 26): Abnormal CS	6 Participants	0 Participants
Change in Physical Examination 3) Gastrointestinal system (wk -2): Normal	149 Participants	152 Participants
Change in Physical Examination 3) Gastrointestinal system (wk -2): Abnormal NCS	14 Participants	9 Participants
Change in Physical Examination 3) Gastrointestinal system (wk -2): Abnormal CS	0 Participants	0 Participants
Change in Physical Examination 3) Gastrointestinal system (wk 26): Normal	146 Participants	145 Participants
Change in Physical Examination 3) Gastrointestinal system (wk 26): Abnormal NCS	9 Participants	7 Participants
Change in Physical Examination 3) Gastrointestinal system (wk 26): Abnormal CS	0 Participants	1 Participants
Change in Physical Examination 4) General appearance (wk -2): Normal	133 Participants	138 Participants
Change in Physical Examination 4) General appearance (wk -2): Abnormal NCS	27 Participants	20 Participants
Change in Physical Examination 4) General appearance (wk -2): Abnormal CS	3 Participants	3 Participants
Change in Physical Examination 4) General appearance (wk 26): Normal	139 Participants	137 Participants
Change in Physical Examination 4) General appearance (wk 26): Abnormal NCS	15 Participants	16 Participants
Change in Physical Examination 4) General appearance (wk 26): Abnormal CS	1 Participants	1 Participants
Change in Physical Examination 5) Head, throat, neck (wk -2): Normal	151 Participants	143 Participants
Change in Physical Examination 5) Head, throat, neck (wk -2): Abnormal NCS	10 Participants	15 Participants
Change in Physical Examination 5) Head, throat, neck (wk -2): Abnormal CS	2 Participants	3 Participants
Change in Physical Examination 5) Head, throat, neck (wk 26): Normal	142 Participants	139 Participants
Change in Physical Examination 5) Head, throat, neck (wk 26): Abnormal NCS	10 Participants	11 Participants
Change in Physical Examination 5) Head, throat, neck (wk 26): Abnormal CS	3 Participants	3 Participants
Change in Physical Examination 6) Lymph node palpation (wk -2): Normal	161 Participants	161 Participants
Change in Physical Examination 6) Lymph node palpation (wk -2): Abnormal NCS	1 Participants	0 Participants
Change in Physical Examination 6) Lymph node palpation (wk -2): Abnormal CS	0 Participants	0 Participants
Change in Physical Examination 6) Lymph node palpation (wk 26): Normal	155 Participants	154 Participants
Change in Physical Examination 6) Lymph node palpation (wk 26): Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination 6) Lymph node palpation (wk 26): Abnormal CS	0 Participants	0 Participants
Change in Physical Examination 7) Musculoskeletal system (wk -2): Normal	131 Participants	135 Participants
Change in Physical Examination 7) Musculoskeletal system (wk -2): Abnormal NCS	27 Participants	24 Participants
Change in Physical Examination 7) Musculoskeletal system (wk -2): Abnormal CS	5 Participants	2 Participants
Change in Physical Examination 7) Musculoskeletal system (wk 26): Normal	131 Participants	130 Participants
Change in Physical Examination 7) Musculoskeletal system (wk 26): Abnormal NCS	22 Participants	21 Participants
Change in Physical Examination 7) Musculoskeletal system (wk 26): Abnormal CS	2 Participants	2 Participants
Change in Physical Examination 8) Respiratory system (wk -2): Normal	154 Participants	150 Participants
Change in Physical Examination 8) Respiratory system (wk -2): Abnormal NCS	9 Participants	8 Participants
Change in Physical Examination 8) Respiratory system (wk -2): Abnormal CS	0 Participants	3 Participants
Change in Physical Examination 8) Respiratory system (wk 26): Normal	151 Participants	147 Participants
Change in Physical Examination 8) Respiratory system (wk 26): Abnormal NCS	4 Participants	5 Participants
Change in Physical Examination 8) Respiratory system (wk 26): Abnormal CS	0 Participants	2 Participants
Change in Physical Examination 9) Skin (wk -2): Normal	129 Participants	129 Participants
Change in Physical Examination 9) Skin (wk -2): Abnormal NCS	33 Participants	32 Participants
Change in Physical Examination 9) Skin (wk -2): Abnormal CS	1 Participants	0 Participants
Change in Physical Examination 9) Skin (wk 26): Normal	128 Participants	136 Participants
Change in Physical Examination 9) Skin (wk 26): Abnormal NCS	23 Participants	18 Participants
Change in Physical Examination 9) Skin (wk 26): Abnormal CS	4 Participants	0 Participants
Change in Physical Examination 10) Thyroid gland (wk -2): Normal	150 Participants	146 Participants
Change in Physical Examination 10) Thyroid gland (wk -2): Abnormal NCS	12 Participants	15 Participants
Change in Physical Examination 10) Thyroid gland (wk -2): Abnormal CS	1 Participants	0 Participants
Change in Physical Examination 10) Thyroid gland (wk 26): Normal	142 Participants	140 Participants
Change in Physical Examination 10) Thyroid gland (wk 26): Abnormal NCS	12 Participants	14 Participants
Change in Physical Examination 10) Thyroid gland (wk 26): Abnormal CS	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week -2, week 26

Participants with eye examination findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Eye Examination Left eye (week -2): Normal	57 Participants	66 Participants
Change in Eye Examination Left eye (week -2): Abnormal NCS	98 Participants	93 Participants
Change in Eye Examination Left eye (week -2): Abnormal CS	8 Participants	0 Participants
Change in Eye Examination Left eye (week 26): Normal	54 Participants	55 Participants
Change in Eye Examination Left eye (week 26): Abnormal NCS	92 Participants	95 Participants
Change in Eye Examination Left eye (week 26): Abnormal CS	5 Participants	0 Participants
Change in Eye Examination Right eye (week -2): Normal	59 Participants	66 Participants
Change in Eye Examination Right eye (week -2): Abnormal NCS	97 Participants	93 Participants
Change in Eye Examination Right eye (week -2): Abnormal CS	7 Participants	0 Participants
Change in Eye Examination Right eye (week 26): Normal	52 Participants	55 Participants
Change in Eye Examination Right eye (week 26): Abnormal NCS	97 Participants	95 Participants
Change in Eye Examination Right eye (week 26): Abnormal CS	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 0-31

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

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=162 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)	1 Participants	—

SECONDARY outcome

Timeframe: Weeks 0-31

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

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=162 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)	0 Participants	—

SECONDARY outcome

Timeframe: Weeks 0-31

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

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=162 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)	1 Participants	—

SECONDARY outcome

Timeframe: Weeks 0-31

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

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=162 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)	0 Participants	—

SECONDARY outcome

Timeframe: Weeks 0-31

Population: Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies. As only one subject was analyzed, standard deviation could not be calculated.

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-31). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=1 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Anti-semaglutide Binding Antibody Levels Week 4	3.1 %B/T Standard Deviation NA As only one subject was analyzed, standard deviation could not be calculated.	—
Anti-semaglutide Binding Antibody Levels Week 31	2.2 %B/T Standard Deviation NA As only one subject was analyzed, standard deviation could not be calculated.	—

SECONDARY outcome

Timeframe: Weeks 0-26

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

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Semaglutide plasma concentrations were measured at weeks 4, 8, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Semaglutide Plasma Concentrations for Population PK Analyses Week 4	1.8 Nanomoles per litre (nmol/L) Geometric Coefficient of Variation 113.5	—
Semaglutide Plasma Concentrations for Population PK Analyses Week 8	5.2 Nanomoles per litre (nmol/L) Geometric Coefficient of Variation 143.4	—
Semaglutide Plasma Concentrations for Population PK Analyses Week 14	9.4 Nanomoles per litre (nmol/L) Geometric Coefficient of Variation 206.6	—
Semaglutide Plasma Concentrations for Population PK Analyses Week 26	6.9 Nanomoles per litre (nmol/L) Geometric Coefficient of Variation 251.3	—

SECONDARY outcome

Timeframe: Weeks 0-26

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

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Sodium N-\[8-(2-hydroxybenzoyl) amino\]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at weeks 4, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
SNAC Plasma Concentrations Week 4: 40 minutes post-dose	364 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 308.5	—
SNAC Plasma Concentrations Week 4: 25 minutes post-dose	578 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 347.4	—
SNAC Plasma Concentrations Week 14: 25 minutes post-dose	418 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 389.7	—
SNAC Plasma Concentrations Week 14: 40 minutes post-dose	330 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 349.2	—
SNAC Plasma Concentrations Week 26: 25 minutes post-dose	435 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 688.0	—
SNAC Plasma Concentrations Week 26: 40 minutes post-dose	288 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 596.1	—

SECONDARY outcome

Timeframe: Week 0, week 26

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

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 26. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) 1) Physical functioning	0.71 Score Standard Deviation 7.21	-0.41 Score Standard Deviation 6.43
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) 2) Role functioning	1.97 Score Standard Deviation 8.43	-0.36 Score Standard Deviation 7.76
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) 3) Bodily pain	3.18 Score Standard Deviation 10.14	-0.33 Score Standard Deviation 11.47
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) 4) General health	0.18 Score Standard Deviation 6.01	-0.13 Score Standard Deviation 5.77
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) 5) Vitality	0.05 Score Standard Deviation 7.53	0.56 Score Standard Deviation 8.02
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) 6) Social functioning	1.87 Score Standard Deviation 7.81	-0.06 Score Standard Deviation 9.64
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) 7) Role emotional	0.62 Score Standard Deviation 10.83	-1.18 Score Standard Deviation 12.32
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) 8) Mental health	0.34 Score Standard Deviation 8.72	-0.19 Score Standard Deviation 9.48
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) Physical component summary (PCS)	1.78 Score Standard Deviation 7.16	-0.15 Score Standard Deviation 6.10
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) Mental component summary (MCS)	0.26 Score Standard Deviation 8.74	-0.32 Score Standard Deviation 10.15

SECONDARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=152 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=154 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) 1) Satisfaction with treatment	0.41 Score Standard Deviation 1.56	0.74 Score Standard Deviation 1.57
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) 2) Feeling of unacceptably high blood sugars	-1.26 Score Standard Deviation 2.17	-0.30 Score Standard Deviation 2.08
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) 3) Feeling of unacceptably low blood sugars	0.11 Score Standard Deviation 1.84	-0.32 Score Standard Deviation 1.82
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) 4) Convenience of treatment	0.43 Score Standard Deviation 1.41	0.42 Score Standard Deviation 1.76
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) 5) Flexibility of treatment	0.37 Score Standard Deviation 1.45	0.52 Score Standard Deviation 1.45
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) 6) Satisfaction with understanding of diabetes	0.31 Score Standard Deviation 1.42	0.60 Score Standard Deviation 1.59
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) 7) Recommending treatment to others	0.71 Score Standard Deviation 1.73	0.37 Score Standard Deviation 1.61
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) 8) Satisfaction to continue with present treatment	0.58 Score Standard Deviation 1.84	0.47 Score Standard Deviation 1.87
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) Total treatment satisfaction	2.82 Score Standard Deviation 6.61	3.13 Score Standard Deviation 7.25

SECONDARY outcome

Timeframe: Week -2, week 26

Participants with urinalysis, "leukocytes and erythrocytes" findings, negative, trace, small, moderate or large at baseline (week \[wk\] 0) and wk 26 are presented. Participants with urinalysis, "nitrit" findings, negative or positive at baseline (wk 0) and wk 26 are presented. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=163 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 Participants Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Change in Urinalysis Leucocytes (wk 0): Negative	121 Participants	122 Participants
Change in Urinalysis Leucocytes (wk 0): Trace	14 Participants	7 Participants
Change in Urinalysis Leucocytes (wk 0): Small	8 Participants	12 Participants
Change in Urinalysis Leucocytes (wk 0): Moderate	10 Participants	9 Participants
Change in Urinalysis Leucocytes (wk 0): Large	5 Participants	5 Participants
Change in Urinalysis Leucocytes (wk 26): Negative	91 Participants	103 Participants
Change in Urinalysis Leucocytes (wk 26): Trace	9 Participants	11 Participants
Change in Urinalysis Leucocytes (wk 26): Small	13 Participants	10 Participants
Change in Urinalysis Leucocytes (wk 26): Moderate	10 Participants	10 Participants
Change in Urinalysis Leucocytes (wk 26): Large	6 Participants	4 Participants
Change in Urinalysis Erythrocytes (wk 0): Negative	147 Participants	137 Participants
Change in Urinalysis Erythrocytes (wk 0): Trace	4 Participants	10 Participants
Change in Urinalysis Erythrocytes (wk 0): Small	4 Participants	4 Participants
Change in Urinalysis Erythrocytes (wk 0): Moderate	1 Participants	1 Participants
Change in Urinalysis Erythrocytes (wk 0): Large	2 Participants	3 Participants
Change in Urinalysis Erythrocytes (wk 26): Negative	115 Participants	122 Participants
Change in Urinalysis Erythrocytes (wk 26): Trace	6 Participants	7 Participants
Change in Urinalysis Erythrocytes (wk 26): Small	6 Participants	3 Participants
Change in Urinalysis Erythrocytes (wk 26): Moderate	2 Participants	4 Participants
Change in Urinalysis Erythrocytes (wk 26): Large	0 Participants	2 Participants
Change in Urinalysis Nitrit (wk 0): Negative	149 Participants	146 Participants
Change in Urinalysis Nitrit (wk 0): Positive	9 Participants	9 Participants
Change in Urinalysis Nitrit (wk 26): Negative	118 Participants	126 Participants
Change in Urinalysis Nitrit (wk 26): Positive	11 Participants	12 Participants

Adverse Events

Oral Semaglutide 14 mg

Serious events: 17 serious events

Other events: 75 other events

Deaths: 1 deaths

Placebo

Serious events: 17 serious events

Other events: 32 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Oral Semaglutide 14 mg n=163 participants at risk Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.	Placebo n=161 participants at risk Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
Musculoskeletal and connective tissue disorders Back pain	0.61% 1/163 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.6% 9/161 • Number of events 9 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Constipation	11.7% 19/163 • Number of events 23 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.7% 6/161 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Metabolism and nutrition disorders Decreased appetite	6.7% 11/163 • Number of events 12 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/161 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Diarrhoea	10.4% 17/163 • Number of events 24 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.7% 6/161 • Number of events 16 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Dyspepsia	9.8% 16/163 • Number of events 20 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.2% 2/161 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Nervous system disorders Headache	6.1% 10/163 • Number of events 13 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.0% 8/161 • Number of events 21 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Nausea	19.0% 31/163 • Number of events 38 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.5% 12/161 • Number of events 12 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Vomiting	11.7% 19/163 • Number of events 29 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.2% 2/161 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER