Trial Outcomes & Findings for Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes (NCT NCT03015220)

NCT ID: NCT03015220

Last Updated: 2021-03-02

Results Overview

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 458 participants
• Primary outcome timeframe: Weeks 0-57
• Results posted on: 2021-03-02

Participant Flow

The trial was conducted at 36 sites in Japan.

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

Participant milestones

Measure	Oral Semaglutide 3 mg Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Overall Study STARTED	131	132	130	65
Overall Study Full Analysis Set (FAS)	131	132	130	65
Overall Study Safety Analysis Set (SAS)	131	132	130	65
Overall Study COMPLETED	128	130	127	63
Overall Study NOT COMPLETED	3	2	3	2

Reasons for withdrawal

Measure	Oral Semaglutide 3 mg Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Overall Study Withdrawal by Subject	3	2	2	2
Overall Study Lost to Follow-up	0	0	1	0

Baseline Characteristics

Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Total n=458 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	59 Years STANDARD_DEVIATION 10 • n=5 Participants	58 Years STANDARD_DEVIATION 11 • n=7 Participants	57 Years STANDARD_DEVIATION 10 • n=5 Participants	61 Years STANDARD_DEVIATION 9 • n=4 Participants	58 Years STANDARD_DEVIATION 10 • n=21 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	42 Participants n=7 Participants	30 Participants n=5 Participants	14 Participants n=4 Participants	117 Participants n=21 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	90 Participants n=7 Participants	100 Participants n=5 Participants	51 Participants n=4 Participants	341 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	131 Participants n=5 Participants	132 Participants n=7 Participants	130 Participants n=5 Participants	65 Participants n=4 Participants	458 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	131 Participants n=5 Participants	132 Participants n=7 Participants	130 Participants n=5 Participants	65 Participants n=4 Participants	458 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Weeks 0-57

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 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Number of Treatment-emergent Adverse Events (TEAEs)	330 Events	350 Events	324 Events	178 Events

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in HbA1c Week 26	-1.1 Percentage of HbA1c Standard Deviation 0.9	-1.7 Percentage of HbA1c Standard Deviation 0.9	-2.0 Percentage of HbA1c Standard Deviation 1.0	-1.6 Percentage of HbA1c Standard Deviation 0.9
Change in HbA1c Week 52	-0.8 Percentage of HbA1c Standard Deviation 1.0	-1.4 Percentage of HbA1c Standard Deviation 1.0	-1.8 Percentage of HbA1c Standard Deviation 1.0	-1.4 Percentage of HbA1c Standard Deviation 0.9

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 fasting plasma glucose (FPG) was evaluated at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Fasting Plasma Glucose Week 26	-1.23 mmol/L Standard Deviation 1.54	-2.25 mmol/L Standard Deviation 1.93	-2.72 mmol/L Standard Deviation 1.86	-2.22 mmol/L Standard Deviation 1.71
Change in Fasting Plasma Glucose Week 52	-0.95 mmol/L Standard Deviation 1.72	-1.96 mmol/L Standard Deviation 1.72	-2.18 mmol/L Standard Deviation 2.50	-1.80 mmol/L Standard Deviation 1.71

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 mean 7-point SMPG profile was evaluated at weeks 26 and 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile Week 26	-1.8 mmol/L Standard Deviation 2.2	-2.7 mmol/L Standard Deviation 2.1	-3.5 mmol/L Standard Deviation 2.3	-2.9 mmol/L Standard Deviation 2.4
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile Week 52	-1.7 mmol/L Standard Deviation 2.1	-2.5 mmol/L Standard Deviation 2.4	-3.3 mmol/L Standard Deviation 2.6	-2.6 mmol/L Standard Deviation 2.6

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 the average of the post-prandial increments over all meals was evaluated at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals Week 26	-0.9 mmol/L Standard Deviation 2.5	-1.3 mmol/L Standard Deviation 2.0	-1.2 mmol/L Standard Deviation 2.4	-0.7 mmol/L Standard Deviation 2.3
Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals Week 52	-0.6 mmol/L Standard Deviation 2.6	-0.8 mmol/L Standard Deviation 2.0	-0.9 mmol/L Standard Deviation 2.6	-0.7 mmol/L Standard Deviation 2.3

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Body Weight (kg) Week 26	-0.1 kg Standard Deviation 2.0	-1.0 kg Standard Deviation 3.0	-2.2 kg Standard Deviation 3.2	0.3 kg Standard Deviation 2.1
Change in Body Weight (kg) Week 52	0.0 kg Standard Deviation 2.4	-0.9 kg Standard Deviation 3.4	-1.7 kg Standard Deviation 3.5	1.0 kg Standard Deviation 2.7

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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

Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Body Weight (%) Week 26	-0.28 Percentage change Standard Deviation 2.79	-1.49 Percentage change Standard Deviation 4.25	-3.21 Percentage change Standard Deviation 4.32	0.25 Percentage change Standard Deviation 3.33
Change in Body Weight (%) Week 52	-0.02 Percentage change Standard Deviation 3.28	-1.34 Percentage change Standard Deviation 4.77	-2.33 Percentage change Standard Deviation 4.67	1.25 Percentage change Standard Deviation 4.06

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 BMI was evaluated at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Body Mass Index (BMI) Week 26	-0.1 Kilogram per square meter (kg/m^2) Standard Deviation 0.7	-0.4 Kilogram per square meter (kg/m^2) Standard Deviation 1.1	-0.8 Kilogram per square meter (kg/m^2) Standard Deviation 1.2	0.1 Kilogram per square meter (kg/m^2) Standard Deviation 0.8
Change in Body Mass Index (BMI) Week 52	-0.0 Kilogram per square meter (kg/m^2) Standard Deviation 0.9	-0.3 Kilogram per square meter (kg/m^2) Standard Deviation 1.3	-0.6 Kilogram per square meter (kg/m^2) Standard Deviation 1.3	0.3 Kilogram per square meter (kg/m^2) Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 waist circumference was evaluated at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Waist Circumference Week 52	-0.1 Centimeters (cm) Standard Deviation 3.6	-0.8 Centimeters (cm) Standard Deviation 3.9	-1.7 Centimeters (cm) Standard Deviation 4.2	0.7 Centimeters (cm) Standard Deviation 3.6
Change in Waist Circumference Week 26	0.0 Centimeters (cm) Standard Deviation 3.1	-0.6 Centimeters (cm) Standard Deviation 3.4	-1.2 Centimeters (cm) Standard Deviation 4.3	0.3 Centimeters (cm) Standard Deviation 2.9

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 fasting total cholesterol (mmol/L) at weeks 26 and 52 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Fasting Total Cholesterol (Ratio to Baseline) Week 26	0.96 Ratio of fasting total cholesterol Geometric Coefficient of Variation 9.4	0.91 Ratio of fasting total cholesterol Geometric Coefficient of Variation 12.3	0.91 Ratio of fasting total cholesterol Geometric Coefficient of Variation 12.3	0.92 Ratio of fasting total cholesterol Geometric Coefficient of Variation 8.8
Change in Fasting Total Cholesterol (Ratio to Baseline) Week 52	0.98 Ratio of fasting total cholesterol Geometric Coefficient of Variation 12.7	0.95 Ratio of fasting total cholesterol Geometric Coefficient of Variation 13.3	0.94 Ratio of fasting total cholesterol Geometric Coefficient of Variation 12.5	0.93 Ratio of fasting total cholesterol Geometric Coefficient of Variation 11.4

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) Week 26	0.92 Ratio of fasting LDL Geometric Coefficient of Variation 15.9	0.88 Ratio of fasting LDL Geometric Coefficient of Variation 18.4	0.87 Ratio of fasting LDL Geometric Coefficient of Variation 20.7	0.88 Ratio of fasting LDL Geometric Coefficient of Variation 14.5
Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) Week 52	0.98 Ratio of fasting LDL Geometric Coefficient of Variation 17.4	0.94 Ratio of fasting LDL Geometric Coefficient of Variation 19.0	0.92 Ratio of fasting LDL Geometric Coefficient of Variation 18.6	0.91 Ratio of fasting LDL Geometric Coefficient of Variation 16.2

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) Week 26	1.02 Ratio of fasting HDL Geometric Coefficient of Variation 13.1	0.99 Ratio of fasting HDL Geometric Coefficient of Variation 12.8	1.00 Ratio of fasting HDL Geometric Coefficient of Variation 12.5	0.99 Ratio of fasting HDL Geometric Coefficient of Variation 11.6
Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) Week 52	1.03 Ratio of fasting HDL Geometric Coefficient of Variation 11.2	0.99 Ratio of fasting HDL Geometric Coefficient of Variation 14.5	1.01 Ratio of fasting HDL Geometric Coefficient of Variation 13.1	1.00 Ratio of fasting HDL Geometric Coefficient of Variation 11.6

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) Week 26	1.03 Ratio of fasting VLDL Geometric Coefficient of Variation 37.9	0.92 Ratio of fasting VLDL Geometric Coefficient of Variation 32.3	0.96 Ratio of fasting VLDL Geometric Coefficient of Variation 33.6	0.93 Ratio of fasting VLDL Geometric Coefficient of Variation 33.5
Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) Week 52	0.90 Ratio of fasting VLDL Geometric Coefficient of Variation 33.3	0.87 Ratio of fasting VLDL Geometric Coefficient of Variation 39.4	0.86 Ratio of fasting VLDL Geometric Coefficient of Variation 36.9	0.88 Ratio of fasting VLDL Geometric Coefficient of Variation 31.6

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 fasting triglycerides (mmol/L) at weeks 26 and 52 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Fasting Triglyceride (Ratio to Baseline) Week 52	0.89 Ratio of fasting triglycerides Geometric Coefficient of Variation 33.9	0.87 Ratio of fasting triglycerides Geometric Coefficient of Variation 43.0	0.87 Ratio of fasting triglycerides Geometric Coefficient of Variation 38.3	0.88 Ratio of fasting triglycerides Geometric Coefficient of Variation 30.8
Change in Fasting Triglyceride (Ratio to Baseline) Week 26	1.03 Ratio of fasting triglycerides Geometric Coefficient of Variation 41.1	0.91 Ratio of fasting triglycerides Geometric Coefficient of Variation 34.1	0.96 Ratio of fasting triglycerides Geometric Coefficient of Variation 34.0	0.93 Ratio of fasting triglycerides Geometric Coefficient of Variation 33.7

SECONDARY outcome

Timeframe: Week 26, week 52

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

Participants who achieved HbA1c below 7.0% (53 millimoles per mole [mmol/mol]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) Week 26 · Yes	59 Participants	96 Participants	105 Participants	45 Participants
Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) Week 26 · No	69 Participants	32 Participants	23 Participants	19 Participants
Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) Week 52 · Yes	43 Participants	77 Participants	90 Participants	32 Participants
Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) Week 52 · No	83 Participants	52 Participants	37 Participants	31 Participants

SECONDARY outcome

Timeframe: Week 26, week 52

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

Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) Week 26 · Yes	40 Participants	67 Participants	88 Participants	31 Participants
Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) Week 26 · No	88 Participants	61 Participants	40 Participants	33 Participants
Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) Week 52 · Yes	22 Participants	50 Participants	69 Participants	23 Participants
Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) Week 52 · No	104 Participants	79 Participants	58 Participants	40 Participants

SECONDARY outcome

Timeframe: Week 26, week 52

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

Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 are presented. 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) Week 26 · Yes	39 Participants	63 Participants	84 Participants	25 Participants
Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) Week 26 · No	89 Participants	65 Participants	44 Participants	39 Participants
Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) Week 52 · Yes	23 Participants	53 Participants	71 Participants	16 Participants
Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) Week 52 · No	103 Participants	76 Participants	56 Participants	47 Participants

SECONDARY outcome

Timeframe: Week 26, week 52

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

Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) Week 26 · Yes	15 Participants	34 Participants	62 Participants	8 Participants
Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) Week 26 · No	113 Participants	94 Participants	66 Participants	56 Participants
Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) Week 52 · Yes	11 Participants	32 Participants	42 Participants	7 Participants
Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) Week 52 · No	115 Participants	97 Participants	85 Participants	56 Participants

SECONDARY outcome

Timeframe: Week 26, week 52

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

Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). Week 26 · Yes	6 Participants	23 Participants	39 Participants	4 Participants
Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). Week 26 · No	122 Participants	105 Participants	89 Participants	60 Participants
Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). Week 52 · Yes	7 Participants	21 Participants	28 Participants	4 Participants
Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). Week 52 · No	120 Participants	108 Participants	99 Participants	59 Participants

SECONDARY outcome

Timeframe: Week 26, week 52

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

Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) Week 26 · No	128 Participants	122 Participants	120 Participants	63 Participants
Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) Week 52 · Yes	0 Participants	9 Participants	7 Participants	0 Participants
Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) Week 52 · No	127 Participants	120 Participants	120 Participants	63 Participants
Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) Week 26 · Yes	0 Participants	6 Participants	8 Participants	1 Participants

SECONDARY outcome

Timeframe: Weeks 0-52

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 periods, from week 0 to week 26 and week 0 to week 52. 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, 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Time to Additional Anti-diabetic Medication Week 0 to week 26	1 Participants	3 Participants	6 Participants	1 Participants
Time to Additional Anti-diabetic Medication Week 0 to week 52	24 Participants	13 Participants	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Weeks 0-52

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 periods, from week 0 to week 26 and week 0 to week 52. 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Time to Rescue Medication Week 0 to week 26	0 Participants	0 Participants	1 Participants	1 Participants
Time to Rescue Medication Week 0 to week 52	22 Participants	8 Participants	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 amylase (measured as units per liter [U/L]) at weeks 26 and 52 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Amylase (Ratio to Baseline) Week 26	1.01 Ratio of amylase Geometric Coefficient of Variation 15.1	1.07 Ratio of amylase Geometric Coefficient of Variation 18.1	1.10 Ratio of amylase Geometric Coefficient of Variation 19.4	1.05 Ratio of amylase Geometric Coefficient of Variation 23.4
Change in Amylase (Ratio to Baseline) Week 52	1.03 Ratio of amylase Geometric Coefficient of Variation 18.5	1.10 Ratio of amylase Geometric Coefficient of Variation 23.8	1.11 Ratio of amylase Geometric Coefficient of Variation 20.0	1.07 Ratio of amylase Geometric Coefficient of Variation 18.8

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 lipase (measured as U/L) at weeks 26 and 52 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Lipase (Ratio to Baseline) Week 26	1.15 Ratio of lipase Geometric Coefficient of Variation 37.4	1.27 Ratio of lipase Geometric Coefficient of Variation 35.8	1.40 Ratio of lipase Geometric Coefficient of Variation 42.8	1.14 Ratio of lipase Geometric Coefficient of Variation 48.3
Change in Lipase (Ratio to Baseline) Week 52	1.11 Ratio of lipase Geometric Coefficient of Variation 34.7	1.36 Ratio of lipase Geometric Coefficient of Variation 50.3	1.40 Ratio of lipase Geometric Coefficient of Variation 42.0	1.15 Ratio of lipase Geometric Coefficient of Variation 57.7

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 pulse rate was evaluated at weeks 26 and 52. 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Pulse Rate Week 26	3 Beats per minute (beats/min) Standard Deviation 9	4 Beats per minute (beats/min) Standard Deviation 10	4 Beats per minute (beats/min) Standard Deviation 9	4 Beats per minute (beats/min) Standard Deviation 9
Change in Pulse Rate Week 52	3 Beats per minute (beats/min) Standard Deviation 10	3 Beats per minute (beats/min) Standard Deviation 9	3 Beats per minute (beats/min) Standard Deviation 9	2 Beats per minute (beats/min) Standard Deviation 10

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was evaluated at weeks 26 and 52. 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Blood Pressure Week 52: SBP	-2.0 Millimeters of mercury (mmHg) Standard Deviation 14.0	-2.0 Millimeters of mercury (mmHg) Standard Deviation 13.0	-2.0 Millimeters of mercury (mmHg) Standard Deviation 13.0	-3.0 Millimeters of mercury (mmHg) Standard Deviation 13.0
Change in Blood Pressure Week 26: DBP	-1.0 Millimeters of mercury (mmHg) Standard Deviation 9.0	-1.0 Millimeters of mercury (mmHg) Standard Deviation 9.0	-2.0 Millimeters of mercury (mmHg) Standard Deviation 10.0	-1.0 Millimeters of mercury (mmHg) Standard Deviation 11.0
Change in Blood Pressure Week 52: DBP	0.0 Millimeters of mercury (mmHg) Standard Deviation 9.0	0.0 Millimeters of mercury (mmHg) Standard Deviation 9.0	-1.0 Millimeters of mercury (mmHg) Standard Deviation 10.0	0.0 Millimeters of mercury (mmHg) Standard Deviation 9.0
Change in Blood Pressure Week 26: SBP	-3.0 Millimeters of mercury (mmHg) Standard Deviation 13.0	-5.0 Millimeters of mercury (mmHg) Standard Deviation 13.0	-6.0 Millimeters of mercury (mmHg) Standard Deviation 15.0	-4.0 Millimeters of mercury (mmHg) Standard Deviation 12.0

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 weeks 26 and 52. 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 and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in ECG Evaluation Normal (week 0) to normal (week 26)	103 Participants	110 Participants	99 Participants	54 Participants
Change in ECG Evaluation Normal (week 0) to abnormal NCS (week 26)	4 Participants	3 Participants	3 Participants	4 Participants
Change in ECG Evaluation Abnormal NCS (week 0) to normal (week 26)	0 Participants	3 Participants	4 Participants	2 Participants
Change in ECG Evaluation Abnormal CS (week 0) to normal (week 26)	1 Participants	0 Participants	0 Participants	0 Participants
Change in ECG Evaluation Abnormal CS (week 0) to abnormal NCS (week 26)	0 Participants	0 Participants	0 Participants	0 Participants
Change in ECG Evaluation Abnormal CS (week 0) to abnormal CS (week 26)	2 Participants	1 Participants	2 Participants	0 Participants
Change in ECG Evaluation Normal (week 0) to normal (week 52)	103 Participants	108 Participants	95 Participants	55 Participants
Change in ECG Evaluation Normal (week 0) to abnormal NCS (week 52)	3 Participants	5 Participants	6 Participants	2 Participants
Change in ECG Evaluation Normal (week 0) to abnormal CS (week 52)	2 Participants	0 Participants	1 Participants	0 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to abnormal NCS (week 52)	13 Participants	10 Participants	18 Participants	3 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to abnormal CS (week 52)	0 Participants	0 Participants	0 Participants	0 Participants
Change in ECG Evaluation Abnormal (week 0) CS to normal (week 52)	1 Participants	1 Participants	0 Participants	0 Participants
Change in ECG Evaluation Abnormal (week 0) CS to abnormal NCS (week 52)	0 Participants	0 Participants	0 Participants	0 Participants
Change in ECG Evaluation Abnormal (week 0) CS to abnormal CS (week 52)	3 Participants	0 Participants	1 Participants	0 Participants
Change in ECG Evaluation Normal (week 0) to abnormal CS (week 26)	2 Participants	0 Participants	0 Participants	0 Participants
Change in ECG Evaluation Abnormal NCS (week 0) to abnormal NCS (week 26)	16 Participants	12 Participants	18 Participants	4 Participants
Change in ECG Evaluation Abnormal NCS (week 0) to abnormal CS (week 26)	0 Participants	0 Participants	2 Participants	0 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to normal (week 52)	2 Participants	5 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Week -2, week 26, week 52

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.

Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 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 rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 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

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week -2) · Abnormal NCS	0 Participants	2 Participants	0 Participants	0 Participants
Change in Physical Examination 1) Cardiovascular system (week -2) · Normal	128 Participants	132 Participants	128 Participants	60 Participants
Change in Physical Examination 1) Cardiovascular system (week -2) · Abnormal NCS	1 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination 1) Cardiovascular system (week -2) · Abnormal CS	2 Participants	0 Participants	2 Participants	4 Participants
Change in Physical Examination 1) Cardiovascular system (week 26) · Normal	125 Participants	128 Participants	125 Participants	59 Participants
Change in Physical Examination 1) Cardiovascular system (week 26) · Abnormal NCS	0 Participants	0 Participants	1 Participants	1 Participants
Change in Physical Examination 1) Cardiovascular system (week 26) · Abnormal CS	3 Participants	0 Participants	2 Participants	4 Participants
Change in Physical Examination 1) Cardiovascular system (week 52) · Normal	124 Participants	129 Participants	126 Participants	58 Participants
Change in Physical Examination 1) Cardiovascular system (week 52) · Abnormal NCS	1 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination 1) Cardiovascular system (week 52) · Abnormal CS	2 Participants	0 Participants	1 Participants	4 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week -2) · Normal	131 Participants	131 Participants	130 Participants	64 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week -2) · Abnormal NCS	0 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week -2) · Abnormal CS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 26) · Normal	128 Participants	127 Participants	128 Participants	62 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 26) · Abnormal NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 26) · Abnormal CS	0 Participants	1 Participants	0 Participants	2 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 56) · Normal	127 Participants	128 Participants	126 Participants	62 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 56) · Abnormal NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week -2) · Normal	126 Participants	128 Participants	129 Participants	60 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week -2) · Abnormal CS	5 Participants	2 Participants	1 Participants	5 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 26) · Normal	122 Participants	123 Participants	125 Participants	60 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 26) · Abnormal NCS	0 Participants	2 Participants	1 Participants	0 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 52) · Normal	122 Participants	124 Participants	126 Participants	59 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 52) · Abnormal NCS	1 Participants	3 Participants	1 Participants	0 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 52) · Abnormal CS	4 Participants	2 Participants	0 Participants	4 Participants
Change in Physical Examination 4.General appearance (week -2) · Normal	131 Participants	132 Participants	130 Participants	64 Participants
Change in Physical Examination 4.General appearance (week -2) · Abnormal NCS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination 4.General appearance (week -2) · Abnormal CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 4.General appearance (week 26) · Normal	127 Participants	128 Participants	127 Participants	62 Participants
Change in Physical Examination 4.General appearance (week 26) · Abnormal NCS	1 Participants	0 Participants	1 Participants	1 Participants
Change in Physical Examination 4.General appearance (week 26) · Abnormal CS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination 4.General appearance (week 52) · Normal	126 Participants	128 Participants	127 Participants	62 Participants
Change in Physical Examination 4.General appearance (week 52) · Abnormal NCS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination 5.Head, ears, eyes, nose, throat, neck (week -2) · Normal	121 Participants	127 Participants	124 Participants	55 Participants
Change in Physical Examination 5.Head, ears, eyes, nose, throat, neck (week -2) · Abnormal NCS	3 Participants	2 Participants	2 Participants	4 Participants
Change in Physical Examination 6. Lymph node palpation (week 26) · Abnormal NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 6. Lymph node palpation (week 26) · Abnormal CS	0 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination 6. Lymph node palpation (week 52) · Abnormal NCS	0 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination 6. Lymph node palpation (week 52) · Abnormal CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 7. Musculoskeletal system (week -2) · Normal	128 Participants	126 Participants	127 Participants	64 Participants
Change in Physical Examination 7. Musculoskeletal system (week -2) · Abnormal CS	2 Participants	3 Participants	1 Participants	1 Participants
Change in Physical Examination 7. Musculoskeletal system (week 26) · Normal	123 Participants	123 Participants	124 Participants	61 Participants
Change in Physical Examination 7. Musculoskeletal system (week 26) · Abnormal CS	3 Participants	3 Participants	2 Participants	3 Participants
Change in Physical Examination 8) Respiratory system (week -2) · Abnormal NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 8) Respiratory system (week -2) · Abnormal CS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination 8) Respiratory system (week 26) · Normal	128 Participants	127 Participants	128 Participants	62 Participants
Change in Physical Examination 8) Respiratory system (week 26) · Abnormal NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 8) Respiratory system (week 26) · Abnormal CS	0 Participants	1 Participants	0 Participants	2 Participants
Change in Physical Examination 8) Respiratory system (week 52) · Normal	126 Participants	127 Participants	127 Participants	62 Participants
Change in Physical Examination 9) Skin (week -2) · Normal	125 Participants	127 Participants	128 Participants	63 Participants
Change in Physical Examination 9) Skin (week -2) · Abnormal NCS	3 Participants	0 Participants	1 Participants	0 Participants
Change in Physical Examination 9) Skin (week -2) · Abnormal CS	3 Participants	5 Participants	1 Participants	2 Participants
Change in Physical Examination 9) Skin (week 26) · Normal	124 Participants	127 Participants	126 Participants	62 Participants
Change in Physical Examination 9) Skin (week 26) · Abnormal NCS	1 Participants	0 Participants	1 Participants	1 Participants
Change in Physical Examination 9) Skin (week 26) · Abnormal CS	3 Participants	1 Participants	1 Participants	1 Participants
Change in Physical Examination 10) Thyroid gland (week 52) · Abnormal CS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination 9) Skin (week 52) · Normal	123 Participants	127 Participants	125 Participants	61 Participants
Change in Physical Examination 9) Skin (week 52) · Abnormal NCS	1 Participants	1 Participants	1 Participants	0 Participants
Change in Physical Examination 9) Skin (week 52) · Abnormal CS	3 Participants	1 Participants	1 Participants	2 Participants
Change in Physical Examination 10) Thyroid gland (week -2) · Normal	130 Participants	130 Participants	129 Participants	64 Participants
Change in Physical Examination 10) Thyroid gland (week -2) · Abnormal NCS	0 Participants	2 Participants	0 Participants	0 Participants
Change in Physical Examination 10) Thyroid gland (week -2) · Abnormal CS	1 Participants	0 Participants	1 Participants	1 Participants
Change in Physical Examination 10) Thyroid gland (week 26) · Normal	128 Participants	128 Participants	128 Participants	63 Participants
Change in Physical Examination 10) Thyroid gland (week 26) · Abnormal NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 10) Thyroid gland (week 26) · Abnormal CS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination 10) Thyroid gland (week 52) · Normal	127 Participants	129 Participants	127 Participants	62 Participants
Change in Physical Examination 10) Thyroid gland (week 52) · Abnormal NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 56) · Abnormal CS	0 Participants	1 Participants	1 Participants	1 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 26) · Abnormal CS	6 Participants	3 Participants	2 Participants	4 Participants
Change in Physical Examination 6. Lymph node palpation (week 52) · Normal	127 Participants	128 Participants	127 Participants	63 Participants
Change in Physical Examination 4.General appearance (week 52) · Abnormal CS	1 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination 5.Head, ears, eyes, nose, throat, neck (week -2) · Abnormal CS	7 Participants	3 Participants	4 Participants	6 Participants
Change in Physical Examination 5.Head, ears, eyes, nose, throat, neck (week 26) · Normal	119 Participants	122 Participants	125 Participants	56 Participants
Change in Physical Examination 5.Head, ears, eyes, nose, throat, neck (week 26) · Abnormal NCS	4 Participants	1 Participants	1 Participants	3 Participants
Change in Physical Examination 5.Head, ears, eyes, nose, throat, neck (week 26) · Abnormal CS	5 Participants	5 Participants	2 Participants	5 Participants
Change in Physical Examination 5.Head, ears, eyes, nose, throat, neck (week 52) · Normal	117 Participants	123 Participants	122 Participants	53 Participants
Change in Physical Examination 5.Head, ears, eyes, nose, throat, neck (week 52) · Abnormal NCS	3 Participants	1 Participants	2 Participants	4 Participants
Change in Physical Examination 5.Head, ears, eyes, nose, throat, neck (week 52) · Abnormal CS	7 Participants	5 Participants	3 Participants	6 Participants
Change in Physical Examination 6. Lymph node palpation (week -2) · Normal	131 Participants	131 Participants	129 Participants	65 Participants
Change in Physical Examination 6. Lymph node palpation (week -2) · Abnormal NCS	0 Participants	1 Participants	1 Participants	0 Participants
Change in Physical Examination 6. Lymph node palpation (week -2) · Abnormal CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 6. Lymph node palpation (week 26) · Normal	128 Participants	127 Participants	128 Participants	64 Participants
Change in Physical Examination 7. Musculoskeletal system (week -2) · Abnormal NCS	1 Participants	3 Participants	2 Participants	0 Participants
Change in Physical Examination 7. Musculoskeletal system (week 26) · Abnormal NCS	2 Participants	2 Participants	2 Participants	0 Participants
Change in Physical Examination 7. Musculoskeletal system (week 52) · Normal	120 Participants	125 Participants	123 Participants	62 Participants
Change in Physical Examination 7. Musculoskeletal system (week 52) · Abnormal NCS	4 Participants	1 Participants	2 Participants	0 Participants
Change in Physical Examination 7. Musculoskeletal system (week 52) · Abnormal CS	3 Participants	3 Participants	2 Participants	1 Participants
Change in Physical Examination 8) Respiratory system (week -2) · Normal	131 Participants	132 Participants	130 Participants	64 Participants
Change in Physical Examination 8) Respiratory system (week 52) · Abnormal NCS	0 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination 8) Respiratory system (week 52) · Abnormal CS	1 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week -2, week 52

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.

Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and 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 rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in Eye Examination Category Left eye (week -2) · Normal	96 Participants	97 Participants	90 Participants	48 Participants
Change in Eye Examination Category Left eye (week -2) · Abnormal CS	28 Participants	33 Participants	38 Participants	13 Participants
Change in Eye Examination Category Left eye (week 52) · Normal	90 Participants	92 Participants	93 Participants	46 Participants
Change in Eye Examination Category Left eye (week 52) · Abnormal NCS	10 Participants	8 Participants	3 Participants	3 Participants
Change in Eye Examination Category Left eye (week 52) · Abnormal CS	26 Participants	29 Participants	31 Participants	14 Participants
Change in Eye Examination Category Right eye (week -2) · Abnormal CS	31 Participants	31 Participants	39 Participants	15 Participants
Change in Eye Examination Category Right eye (week 52) · Normal	93 Participants	90 Participants	90 Participants	48 Participants
Change in Eye Examination Category Right eye (week 52) · Abnormal CS	24 Participants	31 Participants	31 Participants	11 Participants
Change in Eye Examination Category Left eye (week -2) · Abnormal NCS	7 Participants	2 Participants	2 Participants	4 Participants
Change in Eye Examination Category Right eye (week -2) · Normal	94 Participants	98 Participants	89 Participants	44 Participants
Change in Eye Examination Category Right eye (week -2) · Abnormal NCS	6 Participants	3 Participants	2 Participants	6 Participants
Change in Eye Examination Category Right eye (week 52) · Abnormal NCS	9 Participants	8 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Weeks 0-57

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 during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. 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: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes	4 Episodes	4 Episodes	4 Episodes	0 Episodes

SECONDARY outcome

Timeframe: Weeks 0-57

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

Participants with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. 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: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes	3 Participants	3 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

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 weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 1) Physical functioning (week 52)	-0.37 Score on a scale Standard Deviation 3.34	0.70 Score on a scale Standard Deviation 4.08	-0.02 Score on a scale Standard Deviation 4.27	-0.61 Score on a scale Standard Deviation 5.01
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 2) Role Physical (week 26)	-0.58 Score on a scale Standard Deviation 5.12	0.59 Score on a scale Standard Deviation 5.49	-1.01 Score on a scale Standard Deviation 6.00	-0.48 Score on a scale Standard Deviation 5.22
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 3) Bodily Pain (week 26)	-0.88 Score on a scale Standard Deviation 8.39	0.05 Score on a scale Standard Deviation 8.26	-0.99 Score on a scale Standard Deviation 9.32	-0.44 Score on a scale Standard Deviation 7.25
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 3) Bodily Pain (week 52)	-2.72 Score on a scale Standard Deviation 9.74	-0.27 Score on a scale Standard Deviation 8.88	0.01 Score on a scale Standard Deviation 9.48	0.24 Score on a scale Standard Deviation 5.77
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 4)General Health (week 26)	0.42 Score on a scale Standard Deviation 4.59	0.09 Score on a scale Standard Deviation 5.26	0.71 Score on a scale Standard Deviation 5.94	-1.03 Score on a scale Standard Deviation 5.28
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 5) Vitality (week 26)	-1.62 Score on a scale Standard Deviation 7.49	-0.79 Score on a scale Standard Deviation 7.08	-0.83 Score on a scale Standard Deviation 6.84	-1.40 Score on a scale Standard Deviation 7.94
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 5) Vitality (week 52)	-0.90 Score on a scale Standard Deviation 7.29	-0.11 Score on a scale Standard Deviation 7.03	0.09 Score on a scale Standard Deviation 6.83	-0.86 Score on a scale Standard Deviation 7.63
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 6) Social functioning (week 26)	-0.77 Score on a scale Standard Deviation 5.87	-0.15 Score on a scale Standard Deviation 5.95	-0.15 Score on a scale Standard Deviation 6.08	0.15 Score on a scale Standard Deviation 4.98
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 6) Social functioning (week 52)	-1.98 Score on a scale Standard Deviation 8.10	-0.42 Score on a scale Standard Deviation 6.80	-0.12 Score on a scale Standard Deviation 5.92	-0.08 Score on a scale Standard Deviation 6.73
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 7) Role emotional (week 26)	-0.54 Score on a scale Standard Deviation 7.87	0.42 Score on a scale Standard Deviation 6.96	-1.16 Score on a scale Standard Deviation 6.60	-1.01 Score on a scale Standard Deviation 6.28
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 7) Role emotional (week 52)	-1.02 Score on a scale Standard Deviation 7.70	0.59 Score on a scale Standard Deviation 6.89	-1.05 Score on a scale Standard Deviation 8.16	-1.21 Score on a scale Standard Deviation 7.31
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 8) Mental health (week 26)	-1.03 Score on a scale Standard Deviation 6.54	0.16 Score on a scale Standard Deviation 6.66	-0.41 Score on a scale Standard Deviation 7.32	0.27 Score on a scale Standard Deviation 7.34
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 8) Mental health (week 52)	-1.64 Score on a scale Standard Deviation 7.63	-0.35 Score on a scale Standard Deviation 6.68	0.27 Score on a scale Standard Deviation 7.58	-0.31 Score on a scale Standard Deviation 10.24
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Physical component summary (week 26)	-0.17 Score on a scale Standard Deviation 4.19	0.14 Score on a scale Standard Deviation 4.27	-0.23 Score on a scale Standard Deviation 5.24	-0.57 Score on a scale Standard Deviation 4.80
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Physical component summary (week 52)	-0.88 Score on a scale Standard Deviation 4.73	0.19 Score on a scale Standard Deviation 4.91	-0.03 Score on a scale Standard Deviation 5.34	-0.24 Score on a scale Standard Deviation 4.52
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 1) Physical functioning (week 26)	-0.18 Score on a scale Standard Deviation 3.34	0.08 Score on a scale Standard Deviation 4.04	-0.06 Score on a scale Standard Deviation 4.16	-0.24 Score on a scale Standard Deviation 3.71
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 2) Role Physical (week 52)	-0.92 Score on a scale Standard Deviation 5.66	0.05 Score on a scale Standard Deviation 6.13	-0.92 Score on a scale Standard Deviation 7.26	-0.28 Score on a scale Standard Deviation 5.31
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 4)General Health (week 52)	-0.34 Score on a scale Standard Deviation 5.27	0.01 Score on a scale Standard Deviation 5.27	0.59 Score on a scale Standard Deviation 6.13	-0.97 Score on a scale Standard Deviation 6.63
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Mental component summary (week 26)	-1.13 Score on a scale Standard Deviation 6.54	-0.07 Score on a scale Standard Deviation 5.85	-0.71 Score on a scale Standard Deviation 5.91	-0.42 Score on a scale Standard Deviation 6.04
Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Mental component summary (week 52)	-1.52 Score on a scale Standard Deviation 7.26	-0.19 Score on a scale Standard Deviation 6.31	-0.23 Score on a scale Standard Deviation 6.15	-0.74 Score on a scale Standard Deviation 8.57

SECONDARY outcome

Timeframe: week 0, week 26, week 52

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

DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: "Burden on social activities and daily activities", "Anxiety and dissatisfaction with treatment", "Hypoglycemia" and "Satisfaction with treatment" on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively.

Outcome measures

Measure	Oral Semaglutide 3 mg n=131 Participants Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 Participants Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 Participants Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains 1.Burden on social and daily activities (W26)	6.44 Score on a scale Standard Deviation 17.59	6.93 Score on a scale Standard Deviation 18.09	4.88 Score on a scale Standard Deviation 16.46	5.29 Score on a scale Standard Deviation 19.65
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains 1.Burden on social and daily activities (W52)	4.73 Score on a scale Standard Deviation 18.69	6.81 Score on a scale Standard Deviation 18.85	5.44 Score on a scale Standard Deviation 16.57	3.99 Score on a scale Standard Deviation 19.25
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains 2.Anxiety and dissatisfaction with treatment(W52)	0.98 Score on a scale Standard Deviation 18.60	9.93 Score on a scale Standard Deviation 19.61	11.37 Score on a scale Standard Deviation 18.68	3.14 Score on a scale Standard Deviation 19.79
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains 3.Hypoglycemia (W52)	4.20 Score on a scale Standard Deviation 19.61	1.94 Score on a scale Standard Deviation 19.36	3.87 Score on a scale Standard Deviation 20.70	-0.66 Score on a scale Standard Deviation 23.10
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains 4.Satisfaction with treatment(W26)	9.67 Score on a scale Standard Deviation 19.08	10.81 Score on a scale Standard Deviation 24.53	14.29 Score on a scale Standard Deviation 28.11	13.15 Score on a scale Standard Deviation 24.69
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains 4.Satisfaction with treatment(W52)	2.46 Score on a scale Standard Deviation 19.66	7.88 Score on a scale Standard Deviation 23.92	15.49 Score on a scale Standard Deviation 27.01	6.35 Score on a scale Standard Deviation 26.22
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains Total score(W26)	6.74 Score on a scale Standard Deviation 13.01	7.88 Score on a scale Standard Deviation 14.40	7.90 Score on a scale Standard Deviation 12.72	7.18 Score on a scale Standard Deviation 15.56
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains Total score(W52)	3.31 Score on a scale Standard Deviation 13.47	7.15 Score on a scale Standard Deviation 15.69	8.25 Score on a scale Standard Deviation 12.81	3.44 Score on a scale Standard Deviation 14.89
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains 2.Anxiety and dissatisfaction with treatment(W26)	6.54 Score on a scale Standard Deviation 18.08	10.94 Score on a scale Standard Deviation 17.83	12.24 Score on a scale Standard Deviation 17.41	9.24 Score on a scale Standard Deviation 20.87
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains 3.Hypoglycemia (W26)	5.18 Score on a scale Standard Deviation 20.62	1.95 Score on a scale Standard Deviation 18.14	2.67 Score on a scale Standard Deviation 21.14	3.26 Score on a scale Standard Deviation 19.82

Adverse Events

Oral Semaglutide 3 mg

Serious events: 9 serious events

Other events: 65 other events

Deaths: 0 deaths

Oral Semaglutide 7 mg

Serious events: 4 serious events

Other events: 79 other events

Deaths: 0 deaths

Oral Semaglutide 14 mg

Serious events: 7 serious events

Other events: 84 other events

Deaths: 0 deaths

Dulaglutide 0.75 mg

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oral Semaglutide 3 mg n=131 participants at risk Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 participants at risk Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 participants at risk Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 participants at risk Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Cardiac disorders Acute myocardial infarction	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Cardiac disorders Angina pectoris	0.00% 0/131 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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.	0.77% 1/130 • Number of events 1 • Week 0 to week 57 (52 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.	1.5% 1/65 • Number of events 1 • Week 0 to week 57 (52 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.
Infections and infestations Appendicitis	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Cardiac disorders Atrioventricular block second degree	0.00% 0/131 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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.	1.5% 1/65 • Number of events 1 • Week 0 to week 57 (52 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.
Surgical and medical procedures Cardiac ablation	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Infections and infestations Cellulitis	0.00% 0/131 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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.	0.77% 1/130 • Number of events 1 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/131 • Week 0 to week 57 (52 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.	0.76% 1/132 • Number of events 1 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Eye disorders Diabetic retinopathy	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/131 • Week 0 to week 57 (52 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.	0.76% 1/132 • Number of events 1 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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 Gastrointestinal inflammation	0.00% 0/131 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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.	0.77% 1/130 • Number of events 1 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Infections and infestations Herpes zoster	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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 Ischaemic cerebral infarction	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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 Large intestine polyp	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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.	0.76% 1/132 • Number of events 1 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Infections and infestations Osteomyelitis	0.00% 0/131 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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.	0.77% 1/130 • Number of events 1 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Infections and infestations Peritonitis	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Infections and infestations Pneumonia	0.00% 0/131 • Week 0 to week 57 (52 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.	0.76% 1/132 • Number of events 1 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/131 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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.	0.77% 1/130 • Number of events 1 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/131 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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.	0.77% 1/130 • Number of events 1 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Vascular disorders Shock	0.00% 0/131 • Week 0 to week 57 (52 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.	0.76% 1/132 • Number of events 1 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Ear and labyrinth disorders Sudden hearing loss	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/131 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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.	0.77% 1/130 • Number of events 1 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/131 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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.	0.77% 1/130 • Number of events 1 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Surgical and medical procedures Spinal operation	0.76% 1/131 • Number of events 1 • Week 0 to week 57 (52 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% 0/132 • Week 0 to week 57 (52 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% 0/130 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.

Other adverse events

Measure	Oral Semaglutide 3 mg n=131 participants at risk Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 7 mg n=132 participants at risk Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Oral Semaglutide 14 mg n=130 participants at risk Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.	Dulaglutide 0.75 mg n=65 participants at risk Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
Gastrointestinal disorders Abdominal discomfort	2.3% 3/131 • Number of events 4 • Week 0 to week 57 (52 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.	4.5% 6/132 • Number of events 8 • Week 0 to week 57 (52 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.	6.9% 9/130 • Number of events 9 • Week 0 to week 57 (52 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.	1.5% 1/65 • Number of events 1 • Week 0 to week 57 (52 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.
Musculoskeletal and connective tissue disorders Back pain	3.1% 4/131 • Number of events 5 • Week 0 to week 57 (52 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.	3.8% 5/132 • Number of events 6 • Week 0 to week 57 (52 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.	2.3% 3/130 • Number of events 3 • Week 0 to week 57 (52 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.	6.2% 4/65 • Number of events 4 • Week 0 to week 57 (52 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	9.2% 12/131 • Number of events 13 • Week 0 to week 57 (52 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.	12.1% 16/132 • Number of events 16 • Week 0 to week 57 (52 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.	15.4% 20/130 • Number of events 20 • Week 0 to week 57 (52 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.	9.2% 6/65 • Number of events 6 • Week 0 to week 57 (52 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	0.00% 0/131 • Week 0 to week 57 (52 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.	9.1% 12/132 • Number of events 12 • Week 0 to week 57 (52 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.	4.6% 6/130 • Number of events 6 • Week 0 to week 57 (52 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.	4.6% 3/65 • Number of events 3 • Week 0 to week 57 (52 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.
Eye disorders Diabetic retinopathy	4.6% 6/131 • Number of events 6 • Week 0 to week 57 (52 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.	9.1% 12/132 • Number of events 12 • Week 0 to week 57 (52 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.	3.8% 5/130 • Number of events 5 • Week 0 to week 57 (52 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.	3.1% 2/65 • Number of events 2 • Week 0 to week 57 (52 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	1.5% 2/131 • Number of events 2 • Week 0 to week 57 (52 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.	1.5% 2/132 • Number of events 2 • Week 0 to week 57 (52 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.	7.7% 10/130 • Number of events 10 • Week 0 to week 57 (52 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.	6.2% 4/65 • Number of events 4 • Week 0 to week 57 (52 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 Gastrooesophageal reflux disease	3.8% 5/131 • Number of events 5 • Week 0 to week 57 (52 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.	1.5% 2/132 • Number of events 3 • Week 0 to week 57 (52 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.	6.2% 8/130 • Number of events 9 • Week 0 to week 57 (52 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% 0/65 • Week 0 to week 57 (52 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.
Infections and infestations Influenza	6.9% 9/131 • Number of events 9 • Week 0 to week 57 (52 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.	6.8% 9/132 • Number of events 9 • Week 0 to week 57 (52 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.	3.8% 5/130 • Number of events 5 • Week 0 to week 57 (52 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.	3.1% 2/65 • Number of events 2 • Week 0 to week 57 (52 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.
Infections and infestations Nasopharyngitis	26.0% 34/131 • Number of events 49 • Week 0 to week 57 (52 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.	29.5% 39/132 • Number of events 63 • Week 0 to week 57 (52 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.	30.0% 39/130 • Number of events 49 • Week 0 to week 57 (52 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.	29.2% 19/65 • Number of events 27 • Week 0 to week 57 (52 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	5.3% 7/131 • Number of events 8 • Week 0 to week 57 (52 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.	8.3% 11/132 • Number of events 11 • Week 0 to week 57 (52 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.	9.2% 12/130 • Number of events 12 • Week 0 to week 57 (52 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.	9.2% 6/65 • Number of events 9 • Week 0 to week 57 (52 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	3.1% 4/131 • Number of events 6 • Week 0 to week 57 (52 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.	3.0% 4/132 • Number of events 4 • Week 0 to week 57 (52 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.	2.3% 3/130 • Number of events 3 • Week 0 to week 57 (52 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.	7.7% 5/65 • Number of events 6 • Week 0 to week 57 (52 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	2.3% 3/131 • Number of events 3 • Week 0 to week 57 (52 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.	0.76% 1/132 • Number of events 1 • Week 0 to week 57 (52 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.	6.9% 9/130 • Number of events 9 • Week 0 to week 57 (52 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.	1.5% 1/65 • Number of events 1 • Week 0 to week 57 (52 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: clinicaltrials@novonordisk.com

Results disclosure agreements

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