SUSTAIN FORTE: A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03989232
• Collaborator: (none)
• Enrollment: 961
• Locations: 129
• Arms: 2
• Actual Duration (Months): 16.7
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Semaglutide; Drug: Placebo (semaglutide)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 961 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes
• Actual Study Start Date: Jun 19, 2019
• Actual Primary Completion Date: Sep 18, 2020
• Actual Study Completion Date: Nov 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide 2.0 mg All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.	Drug: Semaglutide; Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.
Active Comparator: Semaglutide 1.0 mg All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.	Drug: Semaglutide; Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.; Drug: Placebo (semaglutide); Semaglutide placebo injected once-weekly from week 13 to week 40.

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c [Week 0, week 40]

   Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.

Secondary Outcome Measures

1. Change in Body Weight [Week 0, week 40]

   Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.

2. Change in Fasting Plasma Glucose (FPG) [Week 0, week 40]

   Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.

3. Change in Body Mass Index (BMI) [Week 0, week 40]

   Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.

4. Change in Waist Circumference [Week 0, week 40]

   Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.

5. Participants Who Achieved HbA1c < 7.0% [Week 40]

   Percentage of participants who achieved HbA1c < 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.

6. Participants Who Achieved HbA1c ≤ 6.5% [Week 40]

   Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.

7. Participants Who Achieved Weight Loss ≥5% [Week 40]

   Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.

8. Participants Who Achieved Weight Loss ≥10% [Week 40]

   Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.

9. Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes [Week 0 to week 47]

   Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.

10. Change in Pulse Rate [Week 0, week 40]

    Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, age equal to or above18 years at the time of signing informed consent

• Diagnosed with T2D at least 180 days prior to the day of screening

• HbA1c of 8-10% (64-86 mmol/mol) (both inclusive)

• Stable daily dose(s) for 90 days prior to the day of screening of:

• Any metformin formulations (equal to or above1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)

Exclusion Criteria:

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes

• Renal impairment measured as estimated glomerular filtration rate (eGFR) value of <30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35205
2	Novo Nordisk Investigational Site	Chandler	Arizona	United States	85224
3	Novo Nordisk Investigational Site	Glendale	Arizona	United States	85306
4	Novo Nordisk Investigational Site	Glendale	Arizona	United States	85308
5	Novo Nordisk Investigational Site	Mesa	Arizona	United States	85213
6	Novo Nordisk Investigational Site	Phoenix	Arizona	United States	85050
7	Novo Nordisk Investigational Site	Buena Park	California	United States	90620
8	Novo Nordisk Investigational Site	Fresno	California	United States	93720
9	Novo Nordisk Investigational Site	Los Angeles	California	United States	90057
10	Novo Nordisk Investigational Site	San Diego	California	United States	92103
11	Novo Nordisk Investigational Site	Spring Valley	California	United States	91978
12	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
13	Novo Nordisk Investigational Site	West Hills	California	United States	91304
14	Novo Nordisk Investigational Site	Colorado Springs	Colorado	United States	80906
15	Novo Nordisk Investigational Site	Coral Gables	Florida	United States	33134
16	Novo Nordisk Investigational Site	Hollywood	Florida	United States	33024
17	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32216
18	Novo Nordisk Investigational Site	Adairsville	Georgia	United States	30103
19	Novo Nordisk Investigational Site	Alpharetta	Georgia	United States	30022
20	Novo Nordisk Investigational Site	Roswell	Georgia	United States	30076
21	Novo Nordisk Investigational Site	Meridian	Idaho	United States	83646
22	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60607
23	Novo Nordisk Investigational Site	Gillespie	Illinois	United States	62033
24	Novo Nordisk Investigational Site	Peoria	Illinois	United States	61603
25	Novo Nordisk Investigational Site	Topeka	Kansas	United States	66606
26	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40503
27	Novo Nordisk Investigational Site	Louisville	Kentucky	United States	40213
28	Novo Nordisk Investigational Site	Lake Charles	Louisiana	United States	70601
29	Novo Nordisk Investigational Site	Sterling Heights	Michigan	United States	48310-3503
30	Novo Nordisk Investigational Site	Jefferson City	Missouri	United States	65109
31	Novo Nordisk Investigational Site	Butte	Montana	United States	59701
32	Novo Nordisk Investigational Site	Trenton	New Jersey	United States	08611
33	Novo Nordisk Investigational Site	New Windsor	New York	United States	12553
34	Novo Nordisk Investigational Site	Chapel Hill	North Carolina	United States	27514
35	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
36	Novo Nordisk Investigational Site	Salisbury	North Carolina	United States	28144
37	Novo Nordisk Investigational Site	Statesville	North Carolina	United States	28625
38	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
39	Novo Nordisk Investigational Site	Columbus	Ohio	United States	43213
40	Novo Nordisk Investigational Site	Mason	Ohio	United States	45040-6815
41	Novo Nordisk Investigational Site	Norman	Oklahoma	United States	73069
42	Novo Nordisk Investigational Site	Corvallis	Oregon	United States	97330-3737
43	Novo Nordisk Investigational Site	Gaffney	South Carolina	United States	29341
44	Novo Nordisk Investigational Site	Greenville	South Carolina	United States	29615
45	Novo Nordisk Investigational Site	Chattanooga	Tennessee	United States	37404
46	Novo Nordisk Investigational Site	Kingsport	Tennessee	United States	37660
47	Novo Nordisk Investigational Site	Memphis	Tennessee	United States	38119
48	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
49	Novo Nordisk Investigational Site	Dallas	Texas	United States	75390-9302
50	Novo Nordisk Investigational Site	Houston	Texas	United States	77074
51	Novo Nordisk Investigational Site	Humble	Texas	United States	77338
52	Novo Nordisk Investigational Site	Hurst	Texas	United States	76054
53	Novo Nordisk Investigational Site	Katy	Texas	United States	77450
54	Novo Nordisk Investigational Site	Plano	Texas	United States	75075
55	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78229
56	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78230
57	Novo Nordisk Investigational Site	Shavano Park	Texas	United States	78231
58	Novo Nordisk Investigational Site	Sugar Land	Texas	United States	77479
59	Novo Nordisk Investigational Site	Olympia	Washington	United States	98502
60	Novo Nordisk Investigational Site	Walla Walla	Washington	United States	99362-4445
61	Novo Nordisk Investigational Site	Wenatchee	Washington	United States	98801-2028
62	Novo Nordisk Investigational Site	Kozloduy		Bulgaria	3320
63	Novo Nordisk Investigational Site	Montana		Bulgaria	3400
64	Novo Nordisk Investigational Site	Petrich		Bulgaria	2850
65	Novo Nordisk Investigational Site	Sofia		Bulgaria	1407
66	Novo Nordisk Investigational Site	Sofia		Bulgaria	1431
67	Novo Nordisk Investigational Site	Stara Zagora		Bulgaria	6000
68	Novo Nordisk Investigational Site	Yambol		Bulgaria	8600
69	Novo Nordisk Investigational Site	Mount Pearl	Newfoundland and Labrador	Canada	A1N 1W7
70	Novo Nordisk Investigational Site	Brampton	Ontario	Canada	L6S 0C6
71	Novo Nordisk Investigational Site	Brampton	Ontario	Canada	L6T 0G1
72	Novo Nordisk Investigational Site	Etobicoke	Ontario	Canada	M9R 4E1
73	Novo Nordisk Investigational Site	London	Ontario	Canada	N5W 6A2
74	Novo Nordisk Investigational Site	Markham	Ontario	Canada	L3P 7P2
75	Novo Nordisk Investigational Site	Stoney Creek	Ontario	Canada	L8J 0B6
76	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M4G 3E8
77	Novo Nordisk Investigational Site	Ceske Budejovice		Czechia	370 01
78	Novo Nordisk Investigational Site	Praha 10		Czechia	102 00
79	Novo Nordisk Investigational Site	Praha 5		Czechia	150 00
80	Novo Nordisk Investigational Site	Vlasim		Czechia	25801
81	Novo Nordisk Investigational Site	Athens		Greece	115 25
82	Novo Nordisk Investigational Site	Athens		Greece	GR-10676
83	Novo Nordisk Investigational Site	Athens		Greece	GR-11521
84	Novo Nordisk Investigational Site	Athens		Greece	GR-11527
85	Novo Nordisk Investigational Site	Athens		Greece	GR-17562
86	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54642
87	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-57001
88	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-57010
89	Novo Nordisk Investigational Site	Budapest		Hungary	1042
90	Novo Nordisk Investigational Site	Budapest		Hungary	1089
91	Novo Nordisk Investigational Site	Budapest		Hungary	1125
92	Novo Nordisk Investigational Site	Budapest		Hungary	1131
93	Novo Nordisk Investigational Site	Budapest		Hungary	1132
94	Novo Nordisk Investigational Site	Budapest		Hungary	1152
95	Novo Nordisk Investigational Site	Debrecen		Hungary	4043
96	Novo Nordisk Investigational Site	Debrecen		Hungary	H-4032
97	Novo Nordisk Investigational Site	Kaposvár		Hungary	7400
98	Novo Nordisk Investigational Site	Komarom		Hungary	2900
99	Novo Nordisk Investigational Site	Szeged		Hungary	H-6725
100	Novo Nordisk Investigational Site	Szekszárd		Hungary	7100
101	Novo Nordisk Investigational Site	Tokyo		Japan	103-0027
102	Novo Nordisk Investigational Site	Tokyo		Japan	104-0031
103	Novo Nordisk Investigational Site	Bialystok		Poland	15-404
104	Novo Nordisk Investigational Site	Bialystok		Poland	15-435
105	Novo Nordisk Investigational Site	Gdansk		Poland	80-214
106	Novo Nordisk Investigational Site	Gorzow Wielkopolski		Poland	66-400
107	Novo Nordisk Investigational Site	Katowice		Poland	40-752
108	Novo Nordisk Investigational Site	Lodz		Poland	90-242
109	Novo Nordisk Investigational Site	Lodz		Poland	91-849
110	Novo Nordisk Investigational Site	Lublin		Poland	20-044
111	Novo Nordisk Investigational Site	Warszawa		Poland	02-097
112	Novo Nordisk Investigational Site	Wroclaw		Poland	52-416
113	Novo Nordisk Investigational Site	Manati		Puerto Rico	00674
114	Novo Nordisk Investigational Site	Bratislava		Slovakia	83103
115	Novo Nordisk Investigational Site	Hnusta		Slovakia	98101
116	Novo Nordisk Investigational Site	Kezmarok		Slovakia	06001
117	Novo Nordisk Investigational Site	Kosice		Slovakia	04022
118	Novo Nordisk Investigational Site	Krupina		Slovakia	96301
119	Novo Nordisk Investigational Site	Levice		Slovakia	93401
120	Novo Nordisk Investigational Site	Nove Zamky		Slovakia	94070
121	Novo Nordisk Investigational Site	Pezinok		Slovakia	90201
122	Novo Nordisk Investigational Site	Poprad		Slovakia	05801
123	Novo Nordisk Investigational Site	Povazska Bystrica		Slovakia	01701
124	Novo Nordisk Investigational Site	Puchov		Slovakia	02001
125	Novo Nordisk Investigational Site	Dnipro		Ukraine	49038
126	Novo Nordisk Investigational Site	Mykolaiv		Ukraine	54003
127	Novo Nordisk Investigational Site	Ternopil		Ukraine	46002
128	Novo Nordisk Investigational Site	Vinnytsia		Ukraine	21010
129	Novo Nordisk Investigational Site	Zhytomyr		Ukraine	10002

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

• Study Protocol - Dec 8, 2020
• Statistical Analysis Plan - Dec 15, 2020

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03989232
• Other Study ID Numbers: NN9535-4506; U1111-1224-5162; 2018-004529-96
• First Posted: Jun 18, 2019
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 125 sites in Bulgaria (9), Canada (8), Czech Republic (4), Greece (6), Hungary (12), Japan (2), Poland (10), Slovakia (11), Ukraine (5) and the United States (58). In addition to these sites, 4 sites in the US screened but did not randomize participants, and 3 sites were approved by the IRB/IEC but did not screen or assign any participants to treatment.
Pre-assignment Detail	Participants with type 2 diabetes (T2D) treated with stable doses of metformin only, or metformin in combination with sulfonylurea (SU), in need of the treatment intensification were randomized 1:1 to once-weekly treatment with semaglutide 2.0 milligrams (mg) or once-weekly treatment with semaglutide 1.0 mg.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Period Title: Overall Study
STARTED	481	480
Exposed	480	479
Safety Analysis Set (SAS)	480	479
Full Analysis Set (FAS)	481	480
COMPLETED	471	462
NOT COMPLETED	10	18

Baseline Characteristics

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg	Total
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.	Total of all reporting groups
Overall Participants	481	480	961
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.2 (9.9)	57.9 (10.0)	58.0 (10.0)
Sex: Female, Male (Count of Participants)
Female	197 41%	201 41.9%	398 41.4%
Male	284 59%	279 58.1%	563 58.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	59 12.3%	52 10.8%	111 11.6%
Not Hispanic or Latino	422 87.7%	428 89.2%	850 88.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska native	1 0.2%	0 0%	1 0.1%
Asian	36 7.5%	33 6.9%	69 7.2%
Black or African American	17 3.5%	26 5.4%	43 4.5%
Native Hawaiian or Other Pacific	0 0%	0 0%	0 0%
White	427 88.8%	420 87.5%	847 88.1%
Other	0 0%	1 0.2%	1 0.1%

Outcome Measures

1. Primary Outcome

Title	Change in HbA1c
Description	Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Time Frame	Week 0, week 40

Outcome Measure Data

Analysis Population Description

The FAS included all randomized participants. Number analyzed=number of participants contributed to the analysis.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	481	480
On-treatment without rescue medication	-2.0 (1.0)	-2.2 (1.0)
In-trial	-1.9 (1.0)	-2.2 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Semaglutide 1.0 mg, Semaglutide 2.0 mg
	Comments	On-treatment without rescue medication observation period: Imputation of missing data was handled by multiple imputation (MI) assuming that missing data were missed at random (MAR). The imputation was performed separately within each treatment group defined by randomised treatment.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95%; -0.36 to -0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Semaglutide 1.0 mg, Semaglutide 2.0 mg
	Comments	In-trial observation period: Imputation of missing data was handled by MI assuming that missing data were missed at random. The imputation was performed by imputing missing week 40 data separately within groups defined by randomised treatment and treatment status at week 40.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0098
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.31 to -0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Body Weight
Description	Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Time Frame	Week 0, week 40

Outcome Measure Data

Analysis Population Description

The FAS included all randomized participants. Number analyzed=number of participants contributed to the analysis.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	481	480
On-treatment without rescue medication	-6.0 (5.8)	-7.0 (5.8)
In-trial	-5.7 (5.9)	-6.7 (5.9)

3. Secondary Outcome

Title	Change in Fasting Plasma Glucose (FPG)
Description	Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Time Frame	Week 0, week 40

Outcome Measure Data

Analysis Population Description

The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	423	429
Mean (Standard Deviation) [Millimoles per liter (mmol/L)]	-3.2 (2.8)	-3.4 (3.1)

4. Secondary Outcome

Title	Change in Body Mass Index (BMI)
Description	Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Time Frame	Week 0, week 40

Outcome Measure Data

Analysis Population Description

The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	425	434
Mean (Standard Deviation) [Kilogram per squaremeter (Kg/m^2)]	-2.1 (2.1)	-2.5 (2.1)

5. Secondary Outcome

Title	Change in Waist Circumference
Description	Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Time Frame	Week 0, week 40

Outcome Measure Data

Analysis Population Description

The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	423	433
Mean (Standard Deviation) [Centimeter (cm)]	-5.2 (6.1)	-5.9 (6.2)

6. Secondary Outcome

Title	Participants Who Achieved HbA1c < 7.0%
Description	Percentage of participants who achieved HbA1c < 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Time Frame	Week 40

Outcome Measure Data

Analysis Population Description

The FAS included all randomized participants.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	481	480
Number [Percentage of participants]	57.5 12%	67.6 14.1%

7. Secondary Outcome

Title	Participants Who Achieved HbA1c ≤ 6.5%
Description	Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Time Frame	Week 40

Outcome Measure Data

Analysis Population Description

The FAS included all randomized participants.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	481	480
Number [Percentage of participants]	38.5 8%	51.7 10.8%

8. Secondary Outcome

Title	Participants Who Achieved Weight Loss ≥5%
Description	Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Time Frame	Week 40

Outcome Measure Data

Analysis Population Description

The FAS included all randomized participants.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	481	480
Number [Percentage of participants]	51.3 10.7%	59.2 12.3%

9. Secondary Outcome

Title	Participants Who Achieved Weight Loss ≥10%
Description	Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Time Frame	Week 40

Outcome Measure Data

Analysis Population Description

The FAS included all randomized participants.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	481	480
Number [Percentage of participants]	22.6 4.7%	28.4 5.9%

10. Secondary Outcome

Title	Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Description	Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.
Time Frame	Week 0 to week 47

Outcome Measure Data

Analysis Population Description

The SAS included all participants exposed to at least one dose of trial product.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	480	479
Number [Episodes]	28	21

11. Secondary Outcome

Title	Change in Pulse Rate
Description	Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.
Time Frame	Week 0, week 40

Outcome Measure Data

Analysis Population Description

The SAS included all participants exposed to at least one dose of trial product. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Semaglutide 1.0 mg	Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
Measure Participants	444	442
Mean (Standard Deviation) [Beats per minute]	2.8 (10.0)	3.3 (9.5)

Adverse Events

Time Frame	Weeks 0-47
Adverse Event Reporting Description	All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
Arm/Group Title	Semaglutide 1.0 mg		Semaglutide 2.0 mg
Arm/Group Description	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.		Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
All Cause Mortality
	Semaglutide 1.0 mg		Semaglutide 2.0 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/480 (0.2%)		2/479 (0.4%)
Serious Adverse Events
	Semaglutide 1.0 mg		Semaglutide 2.0 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/480 (5.2%)		21/479 (4.4%)
Blood and lymphatic system disorders
Anaemia	0/480 (0%)	0	1/479 (0.2%)	1
Cardiac disorders
Acute myocardial infarction	2/480 (0.4%)	2	1/479 (0.2%)	1
Angina pectoris	0/480 (0%)	0	1/479 (0.2%)	1
Aortic valve incompetence	1/480 (0.2%)	1	0/479 (0%)	0
Atrial fibrillation	0/480 (0%)	0	1/479 (0.2%)	2
Coronary artery disease	1/480 (0.2%)	1	1/479 (0.2%)	1
Coronary artery stenosis	3/480 (0.6%)	3	0/479 (0%)	0
Supraventricular tachycardia	0/480 (0%)	0	1/479 (0.2%)	1
Ear and labyrinth disorders
Vestibular disorder	0/480 (0%)	0	1/479 (0.2%)	1
Eye disorders
Optic ischaemic neuropathy	0/480 (0%)	0	1/479 (0.2%)	1
Gastrointestinal disorders
Abdominal pain	1/480 (0.2%)	1	0/479 (0%)	0
Colitis	0/480 (0%)	0	1/479 (0.2%)	1
Constipation	0/480 (0%)	0	1/479 (0.2%)	1
Nausea	1/480 (0.2%)	1	0/479 (0%)	0
Oesophagitis	0/480 (0%)	0	1/479 (0.2%)	1
Vomiting	1/480 (0.2%)	1	0/479 (0%)	0
General disorders
Chest discomfort	0/480 (0%)	0	1/479 (0.2%)	1
Death; reason unknown	0/480 (0%)	0	1/479 (0.2%)	1
Hepatobiliary disorders
Cholelithiasis	1/480 (0.2%)	1	0/479 (0%)	0
Infections and infestations
Asymptomatic bacteriuria	1/480 (0.2%)	1	0/479 (0%)	0
COVID-19 pneumonia	1/480 (0.2%)	1	0/479 (0%)	0
Gangrene	0/480 (0%)	0	1/479 (0.2%)	1
Pneumonia staphylococcal	1/480 (0.2%)	1	0/479 (0%)	0
Pneumonia viral	0/480 (0%)	0	1/479 (0.2%)	1
Injury, poisoning and procedural complications
Head injury	0/480 (0%)	0	1/479 (0.2%)	1
Ligament rupture	0/480 (0%)	0	1/479 (0.2%)	1
Investigations
Smear cervix abnormal	0/480 (0%)	0	1/479 (0.2%)	1
Transaminases increased	1/480 (0.2%)	1	0/479 (0%)	0
Weight decreased	1/480 (0.2%)	1	0/479 (0%)	0
Metabolism and nutrition disorders
Dehydration	2/480 (0.4%)	2	0/479 (0%)	0
Diabetic ketoacidosis	1/480 (0.2%)	1	0/479 (0%)	0
Hypoglycaemia	1/480 (0.2%)	1	0/479 (0%)	0
Hypokalaemia	2/480 (0.4%)	2	0/479 (0%)	0
Hyponatraemia	1/480 (0.2%)	1	0/479 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	1/480 (0.2%)	1	0/479 (0%)	0
Osteoarthritis	1/480 (0.2%)	1	0/479 (0%)	0
Spinal osteoarthritis	1/480 (0.2%)	3	0/479 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas	0/480 (0%)	0	1/479 (0.2%)	1
B-cell lymphoma	0/480 (0%)	0	1/479 (0.2%)	1
Endometrial cancer	1/480 (0.2%)	1	0/479 (0%)	0
Invasive ductal breast carcinoma	1/480 (0.2%)	1	0/479 (0%)	0
Papillary thyroid cancer	1/480 (0.2%)	1	0/479 (0%)	0
Prostate cancer	0/480 (0%)	0	1/479 (0.2%)	1
Squamous cell carcinoma of the cervix	1/480 (0.2%)	1	0/479 (0%)	0
Nervous system disorders
Migraine	1/480 (0.2%)	1	0/479 (0%)	0
Neuromyelitis optica spectrum disorder	1/480 (0.2%)	1	0/479 (0%)	0
Renal and urinary disorders
Acute kidney injury	2/480 (0.4%)	2	2/479 (0.4%)	2
Chronic kidney disease	1/480 (0.2%)	1	0/479 (0%)	0
Glomerulonephritis membranous	0/480 (0%)	0	1/479 (0.2%)	1
Reproductive system and breast disorders
Adenomyosis	1/480 (0.2%)	1	0/479 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/480 (0%)	0	1/479 (0.2%)	1
Skin and subcutaneous tissue disorders
Urticaria	1/480 (0.2%)	1	0/479 (0%)	0
Vascular disorders
Aortic dilatation	1/480 (0.2%)	1	0/479 (0%)	0
Aortic dissection	0/480 (0%)	0	1/479 (0.2%)	1
Hypertensive crisis	0/480 (0%)	0	1/479 (0.2%)	1
Peripheral arterial occlusive disease	0/480 (0%)	0	1/479 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Semaglutide 1.0 mg		Semaglutide 2.0 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	126/480 (26.3%)		132/479 (27.6%)
Gastrointestinal disorders
Diarrhoea	42/480 (8.8%)	83	45/479 (9.4%)	51
Dyspepsia	25/480 (5.2%)	26	16/479 (3.3%)	17
Nausea	70/480 (14.6%)	98	69/479 (14.4%)	98
Vomiting	32/480 (6.7%)	40	37/479 (7.7%)	55
Metabolism and nutrition disorders
Decreased appetite	18/480 (3.8%)	18	29/479 (6.1%)	29

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.