Trial Outcomes & Findings for Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes (NCT NCT04707469)

Last Updated: 2025-12-09

Results Overview

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1606 participants

Primary outcome timeframe

Baseline (week 0), week 52

Results posted on

2025-12-09

Participant Flow

The trial was conducted in 14 countries (184 sites screened/177 randomised participants) as follows: Australia: 7/6; Bulgaria: 15/15; Canada: 13/13; Croatia: 5/5; Czech Republic: 5/5; Estonia: 6/5; Germany: 8/8; Hungary: 9/9; India: 20/20; Poland: 18/18; Slovakia: 9/9; Slovenia: 5/5; Taiwan: 2/2; United States: 62/57. In addition, Bulgaria (1 site), Canada (1 site), Croatia (1 site) and Poland (1 site) were approved by the institutional review board, but did not randomise any participant.

Participants were randomized in 1:1:1 ratio to receive either 14 milligram (mg), 25 mg or 50 mg oral semaglutide once daily. The trial had a 68-week treatment period (8-16 weeks of dose escalation period and 52-60 weeks of maintenance period), followed by a 5-week follow-up period.

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 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Overall Study STARTED	536	535	535
Overall Study Treated	534	534	534
Overall Study Full Analysis Set (FAS)	536	535	535
Overall Study Safety Analysis Set (SAS)	534	534	534
Overall Study COMPLETED	507	490	505
Overall Study NOT COMPLETED	29	45	30

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 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Overall Study Site closure	0	2	0
Overall Study Physician Decision	2	2	2
Overall Study Death	1	6	2
Overall Study Lost to Follow-up	9	19	14
Overall Study Withdrawal by Subject	17	16	12

Baseline Characteristics

Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Semaglutide 14 mg n=536 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.	Total n=1606 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	0 Participants n=175 Participants
Age, Continuous	58.4 Years STANDARD_DEVIATION 10.4 • n=4 Participants	58.8 Years STANDARD_DEVIATION 10.7 • n=50 Participants	57.6 Years STANDARD_DEVIATION 11.2 • n=518 Participants	58.2 Years STANDARD_DEVIATION 10.8 • n=175 Participants
Sex: Female, Male Female	211 Participants n=4 Participants	231 Participants n=50 Participants	228 Participants n=518 Participants	670 Participants n=175 Participants
Sex: Female, Male Male	325 Participants n=4 Participants	304 Participants n=50 Participants	307 Participants n=518 Participants	936 Participants n=175 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=4 Participants	37 Participants n=50 Participants	36 Participants n=518 Participants	111 Participants n=175 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	498 Participants n=4 Participants	498 Participants n=50 Participants	499 Participants n=518 Participants	1495 Participants n=175 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	1 Participants n=175 Participants
Race (NIH/OMB) Asian	85 Participants n=4 Participants	73 Participants n=50 Participants	111 Participants n=518 Participants	269 Participants n=175 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	2 Participants n=50 Participants	0 Participants n=518 Participants	2 Participants n=175 Participants
Race (NIH/OMB) Black or African American	19 Participants n=4 Participants	22 Participants n=50 Participants	18 Participants n=518 Participants	59 Participants n=175 Participants
Race (NIH/OMB) White	424 Participants n=4 Participants	432 Participants n=50 Participants	398 Participants n=518 Participants	1254 Participants n=175 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	0 Participants n=175 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=4 Participants	6 Participants n=50 Participants	8 Participants n=518 Participants	21 Participants n=175 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), week 52

Population: Full Analysis Set (FAS) which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=497 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=475 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=492 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)	-1.5 Percentage point of HbA1c Standard Deviation 1.3	-1.9 Percentage point of HbA1c Standard Deviation 1.3	-2.1 Percentage point of HbA1c Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in body weight was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=503 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=480 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Body Weight (Week 52)	-4.4 Kilogram (Kg) Standard Deviation 5.2	-7.1 Kilogram (Kg) Standard Deviation 6.8	-8.3 Kilogram (Kg) Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in HbA1c was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=487 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=469 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=491 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in HbA1c (Week 68)	-1.5 Percentage point of HbA1c Standard Deviation 1.3	-1.8 Percentage point of HbA1c Standard Deviation 1.3	-2.0 Percentage point of HbA1c Standard Deviation 1.4

SECONDARY outcome

Timeframe: Week 12, Week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change in HbA1c was evaluated from week 12 to week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=333 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=345 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=339 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Week 12 in HbA1c (Week 52)	-0.4 Percentage point of HbA1c Standard Deviation 1.2	-0.8 Percentage point of HbA1c Standard Deviation 1.1	-1.0 Percentage point of HbA1c Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=494 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=460 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=482 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)	-2.4 millimole per litre (mmol/L) Standard Deviation 3.4	-3.0 millimole per litre (mmol/L) Standard Deviation 3.5	-3.2 millimole per litre (mmol/L) Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in FPG was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=485 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=466 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=485 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in FPG (Week 68)	-2.4 mmol/L Standard Deviation 3.4	-3.0 mmol/L Standard Deviation 3.7	-3.2 mmol/L Standard Deviation 3.4

SECONDARY outcome

Timeframe: At week 52

Population: FAS which comprised all randomised participants.

Percentage of participants who achieved HbA1c \<7.0 % at week 52 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=536 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)	39 Percentage of Participants	50.5 Percentage of Participants	63 Percentage of Participants

SECONDARY outcome

Timeframe: At week 68

Population: FAS which comprised all randomised participants.

Percentage of participants who achieved HbA1c \<7.0 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=536 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)	39.2 Percentage of Participants	49.9 Percentage of Participants	58.9 Percentage of Participants

SECONDARY outcome

Timeframe: At week 52

Population: FAS which comprised all randomised participants.

Percentage of participants who achieved HbA1c \<=6.5 % at week 52 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=536 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)	25.8 Percentage of Participants	39.6 Percentage of Participants	51.2 Percentage of Participants

SECONDARY outcome

Timeframe: At week 68

Population: FAS which comprised all randomised participants.

Percentage of participants who achieved HbA1c \<=6.5 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=536 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)	23.6 Percentage of Participants	35.8 Percentage of Participants	46.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Time to event analyses of rescue medication was evaluated from baseline (week 0) to week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=92 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=54 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=48 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Time to Event Analyses of Rescue Medication	NA Weeks Due to insufficient number of participants with events to calculate via Kaplan Meir, data was not estimable.	NA Weeks Due to insufficient number of participants with events to calculate via Kaplan Meir, data was not estimable.	NA Weeks Due to insufficient number of participants with events to calculate via Kaplan Meir, data was not estimable.

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in body weight was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=477 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Body Weight (Week 68)	-4.5 Kg Standard Deviation 5.5	-7.1 Kg Standard Deviation 7.4	-8.2 Kg Standard Deviation 8.1

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change from baseline (week 0) in body weight was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=503 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=480 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage Change From Baseline in Body Weight (Week 52)	-4.7 Percentage change in body weight Standard Deviation 5.4	-7.3 Percentage change in body weight Standard Deviation 6.6	-8.5 Percentage change in body weight Standard Deviation 7.3

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change from baseline (week 0) in body weight was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=477 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage Change From Baseline in Body Weight (Week 68)	-4.7 Percentage change in body weight Standard Deviation 5.6	-7.2 Percentage change in body weight Standard Deviation 7.1	-8.4 Percentage change in body weight Standard Deviation 7.7

SECONDARY outcome

Timeframe: Week 12, Week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Percentage change in body weight was evaluated from week 12 to week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=370 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=366 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=355 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage Change From Week 12 in Body Weight (Week 52)	-1.5 Percentage change in body weight Standard Deviation 3.6	-3.8 Percentage change in body weight Standard Deviation 5.4	-5.4 Percentage change in body weight Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=503 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=480 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Body Mass Index (BMI) (Week 52)	-1.6 kilogram per square metre (kg/m^2) Standard Deviation 1.8	-2.5 kilogram per square metre (kg/m^2) Standard Deviation 2.5	-2.9 kilogram per square metre (kg/m^2) Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in BMI was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=477 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in BMI (Week 68)	-1.6 kg/m^2 Standard Deviation 1.9	-2.5 kg/m^2 Standard Deviation 2.7	-2.9 kg/m^2 Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in waist circumference was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=502 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=479 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=494 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Waist Circumference (Week 52)	-4 centimetre (cm) Standard Deviation 7	-5 centimetre (cm) Standard Deviation 7	-6 centimetre (cm) Standard Deviation 7

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in waist circumference was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=494 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=476 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=495 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Waist Circumference (Week 68)	-4 cm Standard Deviation 6	-6 cm Standard Deviation 7	-7 cm Standard Deviation 8

SECONDARY outcome

Timeframe: At week 52

Population: FAS which comprised all randomised participants.

Percentage of participants who achieved weight loss \>= 5 % at week 52 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=536 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)	41 Percentage of participants	60 Percentage of participants	67.5 Percentage of participants

SECONDARY outcome

Timeframe: At week 68

Population: FAS which comprised all randomised participants.

Percentage of participants who achieved weight loss \>= 5 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=536 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)	42.2 Percentage of participants	58.5 Percentage of participants	65.7 Percentage of participants

SECONDARY outcome

Timeframe: At week 52

Population: FAS which comprised all randomised participants.

Percentage of participants who achieved weight loss \>= 10 % at week 52 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=536 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)	13.9 Percentage of participants	29 Percentage of participants	37.2 Percentage of participants

SECONDARY outcome

Timeframe: At week 68

Population: FAS which comprised all randomised participants.

Percentage of participants who achieved weight loss \>= 10 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=536 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=535 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)	14.3 Percentage of participants	29.4 Percentage of participants	34.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in total cholesterol was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=490 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=467 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=486 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Total Cholesterol (Week 52)	-0.04 mmol/L Standard Deviation 0.96	-0.15 mmol/L Standard Deviation 1.10	-0.06 mmol/L Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline, Week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in total cholesterol was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=484 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=470 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=487 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Total Cholesterol (Week 68)	-0.03 mmol/L Standard Deviation 0.99	-0.08 mmol/L Standard Deviation 1.05	-0.06 mmol/L Standard Deviation 1.00

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in LDL was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=477 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=454 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=473 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)	0.04 mmol/L Standard Deviation 0.75	-0.01 mmol/L Standard Deviation 0.85	0.11 mmol/L Standard Deviation 0.76

SECONDARY outcome

Timeframe: Baseline, Week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in LDL was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=472 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=459 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=476 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in LDL (Week 68)	0.07 mmol/L Standard Deviation 0.80	0.06 mmol/L Standard Deviation 0.85	0.08 mmol/L Standard Deviation 0.79

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in HDL was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=477 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=453 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=474 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in High Density Lipoproteins (HDL) (Week 52)	0.06 mmol/L Standard Deviation 0.18	0.07 mmol/L Standard Deviation 0.19	0.08 mmol/L Standard Deviation 0.18

SECONDARY outcome

Timeframe: Baseline, Week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in HDL was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=473 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=458 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=476 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in HDL (Week 68)	0.06 mmol/L Standard Deviation 0.19	0.08 mmol/L Standard Deviation 0.21	0.09 mmol/L Standard Deviation 0.20

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in triglycerides was evaluated at week 52. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=489 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=483 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Triglycerides (Week 52)	-0.46 mmol/L Standard Deviation 1.77	-0.65 mmol/L Standard Deviation 2.08	-0.71 mmol/L Standard Deviation 1.40

SECONDARY outcome

Timeframe: Baseline, Week 68

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in triglycerides was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=483 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=469 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=486 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Triglycerides (Week 68)	-0.51 mmol/L Standard Deviation 1.77	-0.65 mmol/L Standard Deviation 2.06	-0.70 mmol/L Standard Deviation 1.43

SECONDARY outcome

Timeframe: From baseline (week 0) up to week 73

Population: Safety Analysis Set (SAS) which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=534 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=534 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=534 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Number of Adverse Events	1641 Events	2055 Events	2115 Events

SECONDARY outcome

Timeframe: From baseline (week 0) up to week 68

Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Hypoglycaemic episodes were classified according to the American Diabetes Association 2018/ International Hypoglycaemia Study Group 2017, where glycemic criteria for level 2 was \< 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=534 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=534 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=534 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3) Level 2	65 Count of episodes	44 Count of episodes	35 Count of episodes
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3) Level 3	0 Count of episodes	0 Count of episodes	1 Count of episodes

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in systolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=456 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=426 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=434 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Systolic Blood Pressure (Week 52)	-4 millimetres of mercury (mmHg) Standard Deviation 14	-6 millimetres of mercury (mmHg) Standard Deviation 13	-6 millimetres of mercury (mmHg) Standard Deviation 14

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in systolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=442 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=414 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=429 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Systolic Blood Pressure (Week 68)	-4 mmHg Standard Deviation 13	-6 mmHg Standard Deviation 13	-5 mmHg Standard Deviation 13

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in diastolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=456 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=426 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=434 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Diastolic Blood Pressure (Week 52)	-2 mmHg Standard Deviation 8	-2 mmHg Standard Deviation 8	-2 mmHg Standard Deviation 8

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in diastolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=442 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=414 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=429 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Diastolic Blood Pressure (Week 68)	-3 mmHg Standard Deviation 8	-3 mmHg Standard Deviation 8	-2 mmHg Standard Deviation 8

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in pulse at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=456 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=426 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=434 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Pulse (Week 52)	2 beats per minute (beats/min) Standard Deviation 10	2 beats per minute (beats/min) Standard Deviation 10	3 beats per minute (beats/min) Standard Deviation 11

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) in pulse at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Oral Semaglutide 14 mg n=442 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=413 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.	Oral Semaglutide 50 mg n=429 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
Change From Baseline in Pulse (Week 68)	1 beats/min Standard Deviation 10	2 beats/min Standard Deviation 10	2 beats/min Standard Deviation 10

Adverse Events

Oral Semaglutide 50 mg

Serious events: 44 serious events

Other events: 314 other events

Deaths: 2 deaths

Oral Semaglutide 14 mg

Serious events: 53 serious events

Other events: 277 other events

Deaths: 2 deaths

Oral Semaglutide 25 mg

Serious events: 57 serious events

Other events: 294 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Oral Semaglutide 50 mg n=534 participants at risk Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.	Oral Semaglutide 14 mg n=534 participants at risk Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.	Oral Semaglutide 25 mg n=534 participants at risk Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.
Gastrointestinal disorders Abdominal pain	3.9% 21/534 • Number of events 27 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	2.6% 14/534 • Number of events 25 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	5.1% 27/534 • Number of events 34 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Gastrointestinal disorders Abdominal pain upper	4.1% 22/534 • Number of events 55 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	2.6% 14/534 • Number of events 17 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	6.0% 32/534 • Number of events 52 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Infections and infestations COVID-19	12.4% 66/534 • Number of events 68 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	11.8% 63/534 • Number of events 65 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	12.0% 64/534 • Number of events 68 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Gastrointestinal disorders Constipation	6.2% 33/534 • Number of events 39 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	7.5% 40/534 • Number of events 46 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	6.6% 35/534 • Number of events 41 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Metabolism and nutrition disorders Decreased appetite	10.9% 58/534 • Number of events 61 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	7.1% 38/534 • Number of events 43 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	7.3% 39/534 • Number of events 42 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Eye disorders Diabetic retinopathy	6.6% 35/534 • Number of events 40 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	7.7% 41/534 • Number of events 44 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	4.9% 26/534 • Number of events 30 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Gastrointestinal disorders Diarrhoea	14.2% 76/534 • Number of events 150 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	12.4% 66/534 • Number of events 84 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	12.9% 69/534 • Number of events 108 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Gastrointestinal disorders Dyspepsia	5.6% 30/534 • Number of events 50 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	5.2% 28/534 • Number of events 32 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	5.4% 29/534 • Number of events 47 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Nervous system disorders Headache	7.1% 38/534 • Number of events 81 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	6.4% 34/534 • Number of events 63 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	5.2% 28/534 • Number of events 81 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Infections and infestations Nasopharyngitis	5.1% 27/534 • Number of events 30 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	4.5% 24/534 • Number of events 28 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	4.1% 22/534 • Number of events 27 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Gastrointestinal disorders Nausea	27.3% 146/534 • Number of events 218 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	18.0% 96/534 • Number of events 119 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	27.2% 145/534 • Number of events 222 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Gastrointestinal disorders Vomiting	18.2% 97/534 • Number of events 184 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	9.7% 52/534 • Number of events 69 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.	17.0% 91/534 • Number of events 155 • Week 0 to week 73 Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.

Additional Information

Clinical Reporting Office (2834)

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