SUSTAIN 10: Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT03191396

Collaborator

(none)

577

Enrollment

Locations

Arms

13.5

Actual Duration (Months)

6.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: Semaglutide Drug: Liraglutide	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

577 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes

Actual Study Start Date :

Jun 27, 2017

Actual Primary Completion Date :

Jul 9, 2018

Actual Study Completion Date :

Aug 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide Half the study participants are randomised to receive semaglutide	Drug: Semaglutide Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any
Active Comparator: Liraglutide Half the study participants are randomised to receive liraglutide	Drug: Liraglutide Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any

Arm

Intervention/Treatment

Experimental: Semaglutide

Half the study participants are randomised to receive semaglutide

Drug: Semaglutide

Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any

Active Comparator: Liraglutide

Half the study participants are randomised to receive liraglutide

Drug: Liraglutide

Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any

Outcome Measures

Primary Outcome Measures

Change in HbA1c [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Secondary Outcome Measures

Change in Body Weight (kg) [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Fasting Plasma Glucose (FPG) [Week 0, week 30]
Mean change from baseline in fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile [Week 0, week 30]
Mean change from baseline in 7-point profile. 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. The mean of the 7-point SMPG profile, defined as the area under the profile, was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals) [Week 0, week 30]
Mean post prandial glucose incrememts over all meals. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Fasting Blood Lipids: Total Cholesterol [Week 0, week 30]
The change from baseline in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol [Week 0, week 30]
The change from baseline in LDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol [Week 0, week 30]
The change from baseline in HDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Fasting Blood Lipids: Triglycerides [Week 0, week 30]
The change from baseline in triglycerides is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Body Mass Index (BMI) [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in BMI. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Waist Circumference [Week 0, week 30]
Mean change in waist circumference (cm) from baseline (week 0) to week 30. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Systolic Blood Pressure [Week 0, week 30]
Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Diastolic Blood Pressure [Week 0, week 30]
Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in Body Weight (%) [Week 0, week 30]
Mean relative change from baseline in body weight measured in percentage. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target [After 30 weeks of treatment]
Percentage of subjects who achieved HbA1c less than 7.0% (53 mmol/mol) according to American Diabetes Association (ADA) target, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target [After 30 weeks of treatment]
Percentage of subjects who achieved HbA1c less than 6.5% (48 mmol/mol) according to AACE target,after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve Weight Loss Above or Equal to 3% [After 30 weeks of treatment]
Percentage of subjects who achieved weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve Weight Loss Above or Equal to 5% [After 30 weeks of treatment]
Percentage of subjects who achieved weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve Weight Loss Above or Equal to 10% [After 30 weeks of treatment]
Percentage of subjects who achieved weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain [After 30 weeks of treatment]
Percentage of subjects who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% [After 30 weeks of treatment]
Percentage of subjects who achieved weight loss above or equal to 1% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3% [After 30 weeks of treatment]
Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5% [After 30 weeks of treatment]
Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10% [After 30 weeks of treatment]
Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains [Week 0, week 30]
Short form-36 version 2 (SF-36v2) is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL). The questionnaire measures the individual overall HRQoL on 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each domain is scored using the sum of the individual item responses and normalised relative to the 2009 US reference population. Overall, the domain scores range from around 0-100 (higher scores indicated a better HRQoL), where the range of possible scores depends on the 2009 US reference population for each domain. The two total summary scores (mental and physical summary components) are calculated through weighted sums of the 8 domain scores. The presented result is the change from baseline (week 0) to week 30 in SF-36v2 scores. A positive change in score indicates an improvement since baseline.
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately [Week 0, week 30]
The DTSQs questionnaire was used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for diabetes in terms of convenience, flexibility and general feelings regarding treatment. Q 1 = "satisfaction with current treatment"; Q 2 = "hyperglycemia"; Q 3 = "hypoglycemia"; Q 4 = "flexibility"; Q 5 = "convenience"; Q 6 = "understanding of diabetes"; Q 7 = "recommend treatment to others"; and Q 8 = "willingness to continue". Each item is rated on a 7-point Likert scale with a score ranging from 0 (ie, very dissatisfied) to 6 (ie, very satisfied). DTSQ items 2 and 3 are rated differently: 0 reflects 'never' and 6 reflects 'most of the time'. The 'treatment satisfaction' score is the sum of 6 of the 8 DTSQs components (Q 1, 4, 5, 6, 7 and 8) (range 0-36). Higher scores on the DTSQ total score indicate higher treatment satisfaction. The results presented is the change from baseline (week 0) to week 30 in DTSQ scores.
Number of Treatment-emergent Adverse Events (TEAE) [Week 0 to week 35]
A TEAE was defined as an adverse event with onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period represents the time period where subjects were considered exposed to trial product.
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes [Week 0 to week 35]
Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes [Week 0 to week 35]
Number of subjects with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes is presented. Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Change in Haematology - Haemoglobin [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Haematology - Haematocrit [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in haematology laboratory parameter haematocrit. Haematocrit is the volume of red blood cells in the total blood. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Haematology - Thrombocytes and Leukocytes [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in haematology laboratory parameters thrombocytes and leukocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Haematology - Erythrocytes [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in haematology laboratory parameter erythrocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Biochemistry - Calcium, Pottassium and Sodium [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters calcium, pottassium and sodium. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Biochemistry - Amylase and Lipase [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters amylase and lypase. Observed data with multiple imputation for missing data is presented. Missing data were imputed using observed data from subjects within the same group defined by actual treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Biochemistry - Creatinine and Bilirubin [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters creatinine and bilirubin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Biochemistry - Albumin [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter albumin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR). [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter eGFR. eGFR is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) as defined in KDIGO guidelines. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Calcitonin [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Change in Pulse Rate [Week 0, week 30]
Mean change from baseline (week 0) to week 30 in pulse rate. Pulse rate is measured as number of heart beats per minute. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: - Male or female, age 18 years or older at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) SGLT-2 inhibitors (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) Exclusion Criteria: - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit at screening - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novo Nordisk Investigational Site	Burgas	Bulgaria	8000
2	Novo Nordisk Investigational Site	Dupnitsa	Bulgaria	2600
3	Novo Nordisk Investigational Site	Lukovit	Bulgaria	5770
4	Novo Nordisk Investigational Site	Madan	Bulgaria	4900
5	Novo Nordisk Investigational Site	Petrich	Bulgaria	2850
6	Novo Nordisk Investigational Site	Ruse	Bulgaria	7000
7	Novo Nordisk Investigational Site	Sliven	Bulgaria	8800
8	Novo Nordisk Investigational Site	Sofia	Bulgaria	1606
9	Novo Nordisk Investigational Site	Vratsa	Bulgaria	3001
10	Novo Nordisk Investigational Site	Brno	Czechia	602 00
11	Novo Nordisk Investigational Site	Brno	Czechia	65691
12	Novo Nordisk Investigational Site	Nachod	Czechia	547 01
13	Novo Nordisk Investigational Site	Praha 10	Czechia	100 00
14	Novo Nordisk Investigational Site	Praha 4	Czechia	140 46
15	Novo Nordisk Investigational Site	Helsinki	Finland	00180
16	Novo Nordisk Investigational Site	Jyväskylä	Finland	40100
17	Novo Nordisk Investigational Site	Kuusamo	Finland	93600
18	Novo Nordisk Investigational Site	Lahti	Finland	15110
19	Novo Nordisk Investigational Site	Oulu	Finland	90220
20	Novo Nordisk Investigational Site	Rauma	Finland	26100
21	Novo Nordisk Investigational Site	Turku	Finland	20100
22	Novo Nordisk Investigational Site	Varkaus	Finland	78300
23	Novo Nordisk Investigational Site	Béziers	France	34500
24	Novo Nordisk Investigational Site	Dambach-la-ville	France	67650
25	Novo Nordisk Investigational Site	DIJON cedex	France	21079
26	Novo Nordisk Investigational Site	LA ROCHELLE cedex	France	17019
27	Novo Nordisk Investigational Site	Le Coudray	France	28630
28	Novo Nordisk Investigational Site	Le Creusot	France	71200
29	Novo Nordisk Investigational Site	Nantes	France	44200
30	Novo Nordisk Investigational Site	Obernai	France	67210
31	Novo Nordisk Investigational Site	Paris	France	75010
32	Novo Nordisk Investigational Site	Paris	France	75877
33	Novo Nordisk Investigational Site	PERPIGNAN cedex	France	66046
34	Novo Nordisk Investigational Site	Schiltigheim	France	67300
35	Novo Nordisk Investigational Site	Strasbourg	France	67000
36	Novo Nordisk Investigational Site	Vandoeuvre Les Nancy	France	54511
37	Novo Nordisk Investigational Site	Venissieux	France	69200
38	Novo Nordisk Investigational Site	Dresden	Germany	01219
39	Novo Nordisk Investigational Site	Essen	Germany	45136
40	Novo Nordisk Investigational Site	Falkensee	Germany	14612
41	Novo Nordisk Investigational Site	Hamburg	Germany	22607
42	Novo Nordisk Investigational Site	Saint Ingbert-Oberwürzbach	Germany	66386
43	Novo Nordisk Investigational Site	Stuttgart	Germany	70378
44	Novo Nordisk Investigational Site	Budapest	Hungary	1033
45	Novo Nordisk Investigational Site	Budapest	Hungary	1125
46	Novo Nordisk Investigational Site	Nagykanizsa	Hungary	8800
47	Novo Nordisk Investigational Site	Pécs	Hungary	7623
48	Novo Nordisk Investigational Site	Siófok	Hungary	8600
49	Novo Nordisk Investigational Site	Szolnok	Hungary	5004
50	Novo Nordisk Investigational Site	Tatabánya	Hungary	2800
51	Novo Nordisk Investigational Site	Zalaegerszeg	Hungary	8900
52	Novo Nordisk Investigational Site	Bergamo	Italy	24127
53	Novo Nordisk Investigational Site	Como	Italy	22042
54	Novo Nordisk Investigational Site	Milano	Italy	20132
55	Novo Nordisk Investigational Site	Pavia	Italy	27100
56	Novo Nordisk Investigational Site	Rome	Italy	00168
57	Novo Nordisk Investigational Site	Lublin	Poland	20-044
58	Novo Nordisk Investigational Site	Lublin	Poland	20-538
59	Novo Nordisk Investigational Site	Szczecin	Poland	70-506
60	Novo Nordisk Investigational Site	Celje	Slovenia	SI-3000
61	Novo Nordisk Investigational Site	Jesenice	Slovenia	SI-4270
62	Novo Nordisk Investigational Site	Koper	Slovenia	SI-6000
63	Novo Nordisk Investigational Site	Ljubljana	Slovenia	1525
64	Novo Nordisk Investigational Site	Alcorcón	Spain	28922
65	Novo Nordisk Investigational Site	Almería	Spain	04001
66	Novo Nordisk Investigational Site	La Roca del Vallés	Spain	08430
67	Novo Nordisk Investigational Site	Palma de Mallorca	Spain	07014
68	Novo Nordisk Investigational Site	Valladolid	Spain	47010
69	Novo Nordisk Investigational Site	Vic (Barcelona)	Spain	08500
70	Novo Nordisk Investigational Site	Kristianstad	Sweden	291 85
71	Novo Nordisk Investigational Site	Lund	Sweden	222 22
72	Novo Nordisk Investigational Site	Stockholm	Sweden	112 81
73	Novo Nordisk Investigational Site	Stockholm	Sweden	171 76
74	Novo Nordisk Investigational Site	Ängelholm	Sweden	262 81
75	Novo Nordisk Investigational Site	Örebro	Sweden	701 85
76	Novo Nordisk Investigational Site	Blackpool	United Kingdom	FY3 7EN
77	Novo Nordisk Investigational Site	Bristol	United Kingdom	BS10 5NB
78	Novo Nordisk Investigational Site	Coventry	United Kingdom	CV2 2DX
79	Novo Nordisk Investigational Site	Crewe	United Kingdom	CW5 5NX
80	Novo Nordisk Investigational Site	Faringdon	United Kingdom	SN7 7YU.
81	Novo Nordisk Investigational Site	Hinckley	United Kingdom	LE10 2SE
82	Novo Nordisk Investigational Site	London	United Kingdom	SW17 0QT
83	Novo Nordisk Investigational Site	Northwood	United Kingdom	HA6 2RN
84	Novo Nordisk Investigational Site	Norwich	United Kingdom	NR4 7TJ
85	Novo Nordisk Investigational Site	Nuneaton	United Kingdom	CV10 7DJ
86	Novo Nordisk Investigational Site	Rhyl	United Kingdom	LL18 1DA
87	Novo Nordisk Investigational Site	Rotherham	United Kingdom	S65 1DA
88	Novo Nordisk Investigational Site	Sidcup	United Kingdom	DA14 6LT
89	Novo Nordisk Investigational Site	Southampton	United Kingdom	SO30 3JB
90	Novo Nordisk Investigational Site	St Helens	United Kingdom	WA9 3DA
91	Novo Nordisk Investigational Site	Truro	United Kingdom	TR1 3LJ
92	Novo Nordisk Investigational Site	Watford	United Kingdom	WD25 7NL

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT03191396

Other Study ID Numbers:

NN9535-4339
2016-004965-22
U1111-1190-5868

First Posted:

Jun 19, 2017

Last Update Posted:

Oct 15, 2019

Last Verified:

Oct 1, 2019

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:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Liraglutide

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 77 sites in 11 countries as follows (number of sites that screened subjects/ number of sites that randomised subjects): Bulgaria (9/ 9); Czech Republic (5/ 5); Finland (8/ 8); France (8/ 8); Hungary (8/ 8); Italy (4/ 4); Poland (3/ 3); Slovenia (4/ 4); Spain (5/ 5); Sweden (6/ 6); United Kingdom (17/ 17)
Pre-assignment Detail	After screening, subjects were required to continue their oral anti-diabetic drug (OAD) pre-trial background medication (i.e. metformin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulphonyl ureas, or combinations of these) throughout the entire trial.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Period Title: Overall Study
STARTED	290	287
COMPLETED	287	282
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg	Total
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Total of all reporting groups
Overall Participants	290	287	577
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.1 (10.5)	58.9 (10.0)	59.5 (10.2)
Sex: Female, Male (Count of Participants)
Female	130 44.8%	120 41.8%	250 43.3%
Male	160 55.2%	167 58.2%	327 56.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 2.1%	3 1%	9 1.6%
Not Hispanic or Latino	268 92.4%	269 93.7%	537 93.1%
Unknown or Not Reported	16 5.5%	15 5.2%	31 5.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 1.7%	3 1%	8 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 0.7%	1 0.3%	3 0.5%
White	264 91%	268 93.4%	532 92.2%
More than one race	3 1%	0 0%	3 0.5%
Unknown or Not Reported	16 5.5%	15 5.2%	31 5.4%

Outcome Measures

1. Primary Outcome

Title	Change in HbA1c
Description	Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [Percentage of glycosylated haemoglobin]	-1.7 (0.9)	-1.1 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Semaglutide 1.0 mg, Liraglutide 1.2 mg
	Comments	The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
	Type of Statistical Test	Non-Inferiority
	Comments	HbA1c non-inferiority was tested using a non-inferiority margin of 0.3.

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The non-inferiority p-value is calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.69
	Confidence Interval	(2-Sided) 95% -0.82 to -0.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	Semaglutide 1.0 mg - Liraglutide 1.2 mg

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Semaglutide 1.0 mg, Liraglutide 1.2 mg
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.69
	Confidence Interval	(2-Sided) 95% -0.82 to -0.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	Semaglutide 1.0 mg - Liraglutide 1.2 mg

2. Secondary Outcome

Title	Change in Body Weight (kg)
Description	Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [kg]	-5.8 (4.7)	-2.0 (4.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Semaglutide 1.0 mg, Liraglutide 1.2 mg
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-3.83
	Confidence Interval	(2-Sided) 95% -4.57 to -3.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	Semaglutide 1.0 mg - Liraglutide 1.2 mg

3. Secondary Outcome

Title	Change in Fasting Plasma Glucose (FPG)
Description	Mean change from baseline in fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [mmol/L]	-2.65 (2.19)	-1.46 (2.42)

4. Secondary Outcome

Title	Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile
Description	Mean change from baseline in 7-point profile. 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. The mean of the 7-point SMPG profile, defined as the area under the profile, was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [mmol/L]	-3.0 (2.0)	-2.1 (2.3)

5. Secondary Outcome

Title	Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)
Description	Mean post prandial glucose incrememts over all meals. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [mmol/L]	-1.0 (1.8)	-0.4 (1.9)

6. Secondary Outcome

Title	Change in Fasting Blood Lipids: Total Cholesterol
Description	The change from baseline in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.96 (16.8)	0.98 (16.9)

7. Secondary Outcome

Title	Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol
Description	The change from baseline in LDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.99 (28.3)	0.99 (27.2)

8. Secondary Outcome

Title	Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol
Description	The change from baseline in HDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Geometric Mean (Geometric Coefficient of Variation) [ratio]	1.01 (14.6)	0.99 (12.9)

9. Secondary Outcome

Title	Change in Fasting Blood Lipids: Triglycerides
Description	The change from baseline in triglycerides is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Geometric Mean (Geometric Coefficient of Variation) [Ratio]	0.83 (41.5)	0.91 (39.5)

10. Secondary Outcome

Title	Change in Body Mass Index (BMI)
Description	Mean change from baseline (week 0) to week 30 in BMI. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [kg/sqm]	-2.0 (1.6)	-0.7 (1.4)

11. Secondary Outcome

Title	Change in Waist Circumference
Description	Mean change in waist circumference (cm) from baseline (week 0) to week 30. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [cm]	-5.2 (5.6)	-2.4 (4.6)

12. Secondary Outcome

Title	Change in Systolic Blood Pressure
Description	Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [mmHg]	-4.3 (13.4)	-3.7 (13.8)

13. Secondary Outcome

Title	Change in Diastolic Blood Pressure
Description	Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [mmHg]	-1.5 (8.6)	-1.3 (8.4)

14. Secondary Outcome

Title	Change in Body Weight (%)
Description	Mean relative change from baseline in body weight measured in percentage. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Mean (Standard Deviation) [percentage of body weight]	-6.1 (4.9)	-2.0 (4.2)

15. Secondary Outcome

Title	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target
Description	Percentage of subjects who achieved HbA1c less than 7.0% (53 mmol/mol) according to American Diabetes Association (ADA) target, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [percentage of participants]	80.4 27.7%	45.9 16%

16. Secondary Outcome

Title	Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target
Description	Percentage of subjects who achieved HbA1c less than 6.5% (48 mmol/mol) according to AACE target,after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [percentage of participants]	58.5 20.2%	24.8 8.6%

17. Secondary Outcome

Title	Subjects Who Achieve Weight Loss Above or Equal to 3%
Description	Percentage of subjects who achieved weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [percentage of participants]	72.7 25.1%	33.9 11.8%

18. Secondary Outcome

Title	Subjects Who Achieve Weight Loss Above or Equal to 5%
Description	Percentage of subjects who achieved weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [Percentage of participants]	55.9 19.3%	17.7 6.2%

19. Secondary Outcome

Title	Subjects Who Achieve Weight Loss Above or Equal to 10%
Description	Percentage of subjects who achieved weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [Percentage of participants]	19.1 6.6%	4.4 1.5%

20. Secondary Outcome

Title	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
Description	Percentage of subjects who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [Percentage of participants]	75.6 26.1%	36.8 12.8%

21. Secondary Outcome

Title	Subjects Who Achieve HbA1c Reduction Above or Equal to 1%
Description	Percentage of subjects who achieved weight loss above or equal to 1% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [Percentage of participants]	82.8 28.6%	48.3 16.8%

22. Secondary Outcome

Title	Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%
Description	Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [Percentage of participants]	62.4 21.5%	20.9 7.3%

23. Secondary Outcome

Title	Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%
Description	Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [Percentage of participants]	49.6 17.1%	11.9 4.1%

24. Secondary Outcome

Title	Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%
Description	Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	After 30 weeks of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Number [Percentage of participants]	17.1 5.9%	3.6 1.3%

25. Secondary Outcome

Title	Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains
Description	Short form-36 version 2 (SF-36v2) is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL). The questionnaire measures the individual overall HRQoL on 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each domain is scored using the sum of the individual item responses and normalised relative to the 2009 US reference population. Overall, the domain scores range from around 0-100 (higher scores indicated a better HRQoL), where the range of possible scores depends on the 2009 US reference population for each domain. The two total summary scores (mental and physical summary components) are calculated through weighted sums of the 8 domain scores. The presented result is the change from baseline (week 0) to week 30 in SF-36v2 scores. A positive change in score indicates an improvement since baseline.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Physical functioning	1.8 (5.8)	1.4 (6.6)
Role-physical	1.4 (7.2)	0.6 (6.7)
Bodily pain	2.2 (9.1)	1.5 (9.8)
General health	2.7 (7.9)	1.6 (7.7)
Social functioning	1.7 (8.7)	0.9 (7.7)
Role-emotional	1.2 (8.5)	1.0 (8.0)
Vitality	3.0 (8.0)	1.1 (8.0)
Mental health	1.7 (8.2)	0.3 (7.2)
Mental component summary	1.7 (7.9)	0.5 (7.5)
Physical component summary	2.1 (6.4)	1.4 (5.9)

26. Secondary Outcome

Title	Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately
Description	The DTSQs questionnaire was used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for diabetes in terms of convenience, flexibility and general feelings regarding treatment. Q 1 = "satisfaction with current treatment"; Q 2 = "hyperglycemia"; Q 3 = "hypoglycemia"; Q 4 = "flexibility"; Q 5 = "convenience"; Q 6 = "understanding of diabetes"; Q 7 = "recommend treatment to others"; and Q 8 = "willingness to continue". Each item is rated on a 7-point Likert scale with a score ranging from 0 (ie, very dissatisfied) to 6 (ie, very satisfied). DTSQ items 2 and 3 are rated differently: 0 reflects 'never' and 6 reflects 'most of the time'. The 'treatment satisfaction' score is the sum of 6 of the 8 DTSQs components (Q 1, 4, 5, 6, 7 and 8) (range 0-36). Higher scores on the DTSQ total score indicate higher treatment satisfaction. The results presented is the change from baseline (week 0) to week 30 in DTSQ scores.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	290	287
Q1. Satisfaction with current treatment	0.9 (1.7)	0.9 (1.5)
Q2. Hyperglycemia	-2.1 (2.1)	-1.6 (2.3)
Q3. Hypoglycemia	0.1 (1.7)	0.1 (1.6)
Q4. Flexibility	0.7 (1.5)	0.6 (1.5)
Q5. Convenience	0.7 (1.5)	0.6 (1.5)
Q6. Understanding of diabetes	0.6 (1.4)	0.5 (1.3)
Q7. Recommend treatment to others	0.7 (1.5)	0.7 (1.4)
Q8. Willingness to continue	1.0 (1.8)	0.9 (1.8)
Treatment satisfaction summary score	4.6 (7.0)	4.2 (6.6)

27. Secondary Outcome

Title	Number of Treatment-emergent Adverse Events (TEAE)
Description	A TEAE was defined as an adverse event with onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period represents the time period where subjects were considered exposed to trial product.
Time Frame	Week 0 to week 35

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Number [Events]	758	691

28. Secondary Outcome

Title	Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Description	Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time Frame	Week 0 to week 35

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Number [Episodes of hypoglycaemia]	8	8

29. Secondary Outcome

Title	Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes
Description	Number of subjects with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes is presented. Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time Frame	Week 0 to week 35

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Number [Participants]	5 1.7%	7 2.4%

30. Secondary Outcome

Title	Change in Haematology - Haemoglobin
Description	Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Geometric Mean (Geometric Coefficient of Variation) [mmol/L]	1.0 (16.0)	1.0 (0.0)

31. Secondary Outcome

Title	Change in Haematology - Haematocrit
Description	Mean change from baseline (week 0) to week 30 in haematology laboratory parameter haematocrit. Haematocrit is the volume of red blood cells in the total blood. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Geometric Mean (Geometric Coefficient of Variation) [percent change]	1.5 (111.7)	1.1 (130.9)

32. Secondary Outcome

Title	Change in Haematology - Thrombocytes and Leukocytes
Description	Mean change from baseline (week 0) to week 30 in haematology laboratory parameters thrombocytes and leukocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Thrombocytes	18.4 (126.0)	21.5 (138.9)
Leukocytes	0.14 (133.2)	0.14 (117.3)

33. Secondary Outcome

Title	Change in Haematology - Erythrocytes
Description	Mean change from baseline (week 0) to week 30 in haematology laboratory parameter erythrocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Geometric Mean (Geometric Coefficient of Variation) [10^12 cells/L]	0.14 (133.2)	0.14 (117.3)

34. Secondary Outcome

Title	Change in Biochemistry - Calcium, Pottassium and Sodium
Description	Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters calcium, pottassium and sodium. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Calcium	0.07 (107.0)	0.07 (103.8)
Pottassium	0.3 (96.0)	0.3 (77.3)
Sodium	1.8 (65.3)	1.7 (61.4)

35. Secondary Outcome

Title	Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.
Description	Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Alkaline phosphatase	5.5 (117.5)	6.4 (121.0)
Alanine Aminotransferase	5.3 (126.1)	5.0 (137.7)
Aspartate Aminotransferase	3.5 (129.9)	3.1 (119.5)

36. Secondary Outcome

Title	Change in Biochemistry - Amylase and Lipase
Description	Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters amylase and lypase. Observed data with multiple imputation for missing data is presented. Missing data were imputed using observed data from subjects within the same group defined by actual treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Amylase	10.3 (124.7)	8.4 (138.2)
Lipase	15.8 (154.6)	14.0 (154.5)

37. Secondary Outcome

Title	Change in Biochemistry - Creatinine and Bilirubin
Description	Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters creatinine and bilirubin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Creatinine	4.1 (150.2)	3.6 (150.0)
Bilirubin	1.9 (167.5)	2.0 (126.2)

38. Secondary Outcome

Title	Change in Biochemistry - Albumin
Description	Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter albumin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Geometric Mean (Geometric Coefficient of Variation) [g/dL]	0.2 (56.8)	0.2 (55.5)

39. Secondary Outcome

Title	Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).
Description	Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter eGFR. eGFR is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) as defined in KDIGO guidelines. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Geometric Mean (Geometric Coefficient of Variation) [mL/min/1.73m2]	4.0 (97.7)	4.1 (113.9)

40. Secondary Outcome

Title	Change in Calcitonin
Description	Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Geometric Mean (Geometric Coefficient of Variation) [ng/L]	1.3 (165.5)	1.1 (89.7)

41. Secondary Outcome

Title	Change in Pulse Rate
Description	Mean change from baseline (week 0) to week 30 in pulse rate. Pulse rate is measured as number of heart beats per minute. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame	Week 0, week 30

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product.

Arm/Group Title	Semaglutide 1.0 mg	Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).	Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Measure Participants	289	287
Geometric Mean (Geometric Coefficient of Variation) [beats/min]	2.4 (10.1)	3.9 (10.0)

Adverse Events

	Semaglutide 1.0 mg		Liraglutide 1.2 mg
Time Frame	From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days.
Adverse Event Reporting Description	Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.

Arm/Group Title	Semaglutide 1.0 mg		Liraglutide 1.2 mg
Arm/Group Description	Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).		Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/289 (0%)		0/287 (0%)
Serious Adverse Events
	Semaglutide 1.0 mg		Liraglutide 1.2 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/289 (5.9%)		22/287 (7.7%)
Cardiac disorders
Bradycardia	0/289 (0%)	0	1/287 (0.3%)	1
Cardiac failure congestive	1/289 (0.3%)	1	0/287 (0%)	0
Coronary artery disease	0/289 (0%)	0	1/287 (0.3%)	1
Eye disorders
Retinal vein occlusion	1/289 (0.3%)	1	0/287 (0%)	0
Gastrointestinal disorders
Abdominal pain upper	1/289 (0.3%)	1	1/287 (0.3%)	1
Colitis	0/289 (0%)	0	1/287 (0.3%)	1
Diarrhoea	0/289 (0%)	0	1/287 (0.3%)	1
Duodenal ulcer haemorrhage	1/289 (0.3%)	1	0/287 (0%)	0
Inguinal hernia	1/289 (0.3%)	1	0/287 (0%)	0
Nausea	1/289 (0.3%)	1	0/287 (0%)	0
Pancreatitis acute	0/289 (0%)	0	1/287 (0.3%)	1
Umbilical hernia	0/289 (0%)	0	1/287 (0.3%)	1
Vomiting	1/289 (0.3%)	1	1/287 (0.3%)	1
General disorders
Facial pain	0/289 (0%)	0	1/287 (0.3%)	1
Hepatobiliary disorders
Cholecystitis	0/289 (0%)	0	1/287 (0.3%)	1
Cholecystitis acute	0/289 (0%)	0	1/287 (0.3%)	1
Cholelithiasis	0/289 (0%)	0	1/287 (0.3%)	1
Hepatic steatosis	0/289 (0%)	0	1/287 (0.3%)	1
Infections and infestations
Device related infection	0/289 (0%)	0	1/287 (0.3%)	1
Localised infection	0/289 (0%)	0	1/287 (0.3%)	1
Pneumonia	0/289 (0%)	0	1/287 (0.3%)	1
Pyelonephritis	2/289 (0.7%)	2	0/287 (0%)	0
Rectal abscess	1/289 (0.3%)	1	0/287 (0%)	0
Sepsis	1/289 (0.3%)	1	1/287 (0.3%)	1
Urinary tract infection	0/289 (0%)	0	1/287 (0.3%)	1
Investigations
Cardiovascular examination	1/289 (0.3%)	1	0/287 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/289 (0.3%)	1	1/287 (0.3%)	1
Diabetes mellitus inadequate control	1/289 (0.3%)	1	0/287 (0%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder	0/289 (0%)	0	1/287 (0.3%)	1
Intervertebral disc protrusion	0/289 (0%)	0	1/287 (0.3%)	1
Osteoarthritis	1/289 (0.3%)	1	0/287 (0%)	0
Periarthritis	0/289 (0%)	0	1/287 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder	1/289 (0.3%)	1	0/287 (0%)	0
Leiomyoma	1/289 (0.3%)	1	0/287 (0%)	0
Medullary thyroid cancer	1/289 (0.3%)	1	0/287 (0%)	0
Prostatic adenoma	0/289 (0%)	0	1/287 (0.3%)	1
Rectal neoplasm	1/289 (0.3%)	1	0/287 (0%)	0
Nervous system disorders
Cognitive disorder	1/289 (0.3%)	1	0/287 (0%)	0
Lethargy	0/289 (0%)	0	1/287 (0.3%)	1
Psychiatric disorders
Confusional state	0/289 (0%)	0	1/287 (0.3%)	1
Depression	0/289 (0%)	0	1/287 (0.3%)	1
Renal and urinary disorders
Acute kidney injury	0/289 (0%)	0	1/287 (0.3%)	1
Calculus urinary	0/289 (0%)	0	1/287 (0.3%)	1
Haematuria	1/289 (0.3%)	1	0/287 (0%)	0
Nephrolithiasis	1/289 (0.3%)	1	0/287 (0%)	0
Reproductive system and breast disorders
Menopausal symptoms	0/289 (0%)	0	1/287 (0.3%)	1
Prostatitis	0/289 (0%)	0	1/287 (0.3%)	1
Skin and subcutaneous tissue disorders
Skin ulcer	0/289 (0%)	0	1/287 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Semaglutide 1.0 mg		Liraglutide 1.2 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	139/289 (48.1%)		113/287 (39.4%)
Gastrointestinal disorders
Abdominal pain	15/289 (5.2%)	18	6/287 (2.1%)	6
Constipation	17/289 (5.9%)	17	10/287 (3.5%)	13
Diarrhoea	45/289 (15.6%)	56	35/287 (12.2%)	43
Nausea	62/289 (21.5%)	88	45/287 (15.7%)	54
Vomiting	29/289 (10%)	43	23/287 (8%)	32
Infections and infestations
Influenza	9/289 (3.1%)	12	15/287 (5.2%)	16
Nasopharyngitis	27/289 (9.3%)	30	30/287 (10.5%)	32
Metabolism and nutrition disorders
Decreased appetite	30/289 (10.4%)	31	17/287 (5.9%)	18
Nervous system disorders
Headache	27/289 (9.3%)	37	19/287 (6.6%)	32

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.

Results Point of Contact

Name/Title	Clinical Reporting Anchor and Disclosure (1452)
Organization	Novo Nordisk A/S
Phone	(+1) 866-867-7178
Email	clinicaltrials@novonordisk.com

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT03191396

Other Study ID Numbers:

NN9535-4339
2016-004965-22
U1111-1190-5868

First Posted:

Jun 19, 2017

Last Update Posted:

Oct 15, 2019

Last Verified:

Oct 1, 2019

SUSTAIN 10: Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact