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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: Semaglutide; Drug: Liraglutide

• Study Type: Interventional
• Enrollment (Actual): 577
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Burgas, Bulgaria, 8000
    • Novo Nordisk Investigational Site
  • Dupnitsa, Bulgaria, 2600
    • Novo Nordisk Investigational Site
  • Lukovit, Bulgaria, 5770
    • Novo Nordisk Investigational Site
  • Madan, Bulgaria, 4900
    • Novo Nordisk Investigational Site
  • Petrich, Bulgaria, 2850
    • Novo Nordisk Investigational Site
  • Ruse, Bulgaria, 7000
    • Novo Nordisk Investigational Site
  • Sliven, Bulgaria, 8800
    • Novo Nordisk Investigational Site
  • Sofia, Bulgaria, 1606
    • Novo Nordisk Investigational Site
  • Vratsa, Bulgaria, 3001
    • Novo Nordisk Investigational Site
• Czechia
  • Brno, Czechia, 602 00
    • Novo Nordisk Investigational Site
  • Brno, Czechia, 65691
    • Novo Nordisk Investigational Site
  • Nachod, Czechia, 547 01
    • Novo Nordisk Investigational Site
  • Praha 10, Czechia, 100 00
    • Novo Nordisk Investigational Site
  • Praha 4, Czechia, 140 46
    • Novo Nordisk Investigational Site
• Finland
  • Helsinki, Finland, 00180
    • Novo Nordisk Investigational Site
  • Jyväskylä, Finland, 40100
    • Novo Nordisk Investigational Site
  • Kuusamo, Finland, 93600
    • Novo Nordisk Investigational Site
  • Lahti, Finland, 15110
    • Novo Nordisk Investigational Site
  • Oulu, Finland, 90220
    • Novo Nordisk Investigational Site
  • Rauma, Finland, 26100
    • Novo Nordisk Investigational Site
  • Turku, Finland, 20100
    • Novo Nordisk Investigational Site
  • Varkaus, Finland, 78300
    • Novo Nordisk Investigational Site
• France
  • Béziers, France, 34500
    • Novo Nordisk Investigational Site
  • DIJON cedex, France, 21079
    • Novo Nordisk Investigational Site
  • Dambach-la-ville, France, 67650
    • Novo Nordisk Investigational Site
  • LA ROCHELLE cedex, France, 17019
    • Novo Nordisk Investigational Site
  • Le Coudray, France, 28630
    • Novo Nordisk Investigational Site
  • Le Creusot, France, 71200
    • Novo Nordisk Investigational Site
  • Nantes, France, 44200
    • Novo Nordisk Investigational Site
  • Obernai, France, 67210
    • Novo Nordisk Investigational Site
  • PERPIGNAN cedex, France, 66046
    • Novo Nordisk Investigational Site
  • Paris, France, 75010
    • Novo Nordisk Investigational Site
  • Paris, France, 75877
    • Novo Nordisk Investigational Site
  • Schiltigheim, France, 67300
    • Novo Nordisk Investigational Site
  • Strasbourg, France, 67000
    • Novo Nordisk Investigational Site
  • Vandoeuvre Les Nancy, France, 54511
    • Novo Nordisk Investigational Site
  • Venissieux, France, 69200
    • Novo Nordisk Investigational Site
• Germany
  • Dresden, Germany, 01219
    • Novo Nordisk Investigational Site
  • Essen, Germany, 45136
    • Novo Nordisk Investigational Site
  • Falkensee, Germany, 14612
    • Novo Nordisk Investigational Site
  • Hamburg, Germany, 22607
    • Novo Nordisk Investigational Site
  • Saint Ingbert-Oberwürzbach, Germany, 66386
    • Novo Nordisk Investigational Site
  • Stuttgart, Germany, 70378
    • Novo Nordisk Investigational Site
• Hungary
  • Budapest, Hungary, 1125
    • Novo Nordisk Investigational Site
  • Budapest, Hungary, 1033
    • Novo Nordisk Investigational Site
  • Nagykanizsa, Hungary, 8800
    • Novo Nordisk Investigational Site
  • Pécs, Hungary, 7623
    • Novo Nordisk Investigational Site
  • Siófok, Hungary, 8600
    • Novo Nordisk Investigational Site
  • Szolnok, Hungary, 5004
    • Novo Nordisk Investigational Site
  • Tatabánya, Hungary, 2800
    • Novo Nordisk Investigational Site
  • Zalaegerszeg, Hungary, 8900
    • Novo Nordisk Investigational Site
• Italy
  • Bergamo, Italy, 24127
    • Novo Nordisk Investigational Site
  • Como, Italy, 22042
    • Novo Nordisk Investigational Site
  • Milano, Italy, 20132
    • Novo Nordisk Investigational Site
  • Pavia, Italy, 27100
    • Novo Nordisk Investigational Site
  • Rome, Italy, 00168
    • Novo Nordisk Investigational Site
• Poland
  • Lublin, Poland, 20-044
    • Novo Nordisk Investigational Site
  • Lublin, Poland, 20-538
    • Novo Nordisk Investigational Site
  • Szczecin, Poland, 70-506
    • Novo Nordisk Investigational Site
• Slovenia
  • Celje, Slovenia, SI-3000
    • Novo Nordisk Investigational Site
  • Jesenice, Slovenia, SI-4270
    • Novo Nordisk Investigational Site
  • Koper, Slovenia, SI-6000
    • Novo Nordisk Investigational Site
  • Ljubljana, Slovenia, 1525
    • Novo Nordisk Investigational Site
• Spain
  • Alcorcón, Spain, 28922
    • Novo Nordisk Investigational Site
  • Almería, Spain, 04001
    • Novo Nordisk Investigational Site
  • La Roca del Vallés, Spain, 08430
    • Novo Nordisk Investigational Site
  • Palma de Mallorca, Spain, 07014
    • Novo Nordisk Investigational Site
  • Valladolid, Spain, 47010
    • Novo Nordisk Investigational Site
  • Vic (Barcelona), Spain, 08500
    • Novo Nordisk Investigational Site
• Sweden
  • Kristianstad, Sweden, 291 85
    • Novo Nordisk Investigational Site
  • Lund, Sweden, 222 22
    • Novo Nordisk Investigational Site
  • Stockholm, Sweden, 171 76
    • Novo Nordisk Investigational Site
  • Stockholm, Sweden, 112 81
    • Novo Nordisk Investigational Site
  • Ängelholm, Sweden, 262 81
    • Novo Nordisk Investigational Site
  • Örebro, Sweden, 701 85
    • Novo Nordisk Investigational Site
• United Kingdom
  • Blackpool, United Kingdom, FY3 7EN
    • Novo Nordisk Investigational Site
  • Bristol, United Kingdom, BS10 5NB
    • Novo Nordisk Investigational Site
  • Coventry, United Kingdom, CV2 2DX
    • Novo Nordisk Investigational Site
  • Crewe, United Kingdom, CW5 5NX
    • Novo Nordisk Investigational Site
  • Faringdon, United Kingdom, SN7 7YU.
    • Novo Nordisk Investigational Site
  • Hinckley, United Kingdom, LE10 2SE
    • Novo Nordisk Investigational Site
  • London, United Kingdom, SW17 0QT
    • Novo Nordisk Investigational Site
  • Northwood, United Kingdom, HA6 2RN
    • Novo Nordisk Investigational Site
  • Norwich, United Kingdom, NR4 7TJ
    • Novo Nordisk Investigational Site
  • Nuneaton, United Kingdom, CV10 7DJ
    • Novo Nordisk Investigational Site
  • Rhyl, United Kingdom, LL18 1DA
    • Novo Nordisk Investigational Site
  • Rotherham, United Kingdom, S65 1DA
    • Novo Nordisk Investigational Site
  • Sidcup, United Kingdom, DA14 6LT
    • Novo Nordisk Investigational Site
  • Southampton, United Kingdom, SO30 3JB
    • Novo Nordisk Investigational Site
  • St Helens, United Kingdom, WA9 3DA
    • Novo Nordisk Investigational Site
  • Truro, United Kingdom, TR1 3LJ
    • Novo Nordisk Investigational Site
  • Watford, United Kingdom, WD25 7NL
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	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.	Week 0, week 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight (kg)	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.	Week 0, week 30
Change in Fasting Plasma Glucose (FPG)	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.	Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile	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.	Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)	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.	Week 0, week 30
Change in Fasting Blood Lipids: Total Cholesterol	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.	Week 0, week 30
Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol	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.	Week 0, week 30
Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol	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.	Week 0, week 30
Change in Fasting Blood Lipids: Triglycerides	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.	Week 0, week 30
Change in Body Mass Index (BMI)	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.	Week 0, week 30
Change in Waist Circumference	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.	Week 0, week 30
Change in Systolic Blood Pressure	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.	Week 0, week 30
Change in Diastolic Blood Pressure	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.	Week 0, week 30
Change in Body Weight (%)	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.	Week 0, week 30
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target	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.	After 30 weeks of treatment
Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target	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.	After 30 weeks of treatment
Subjects Who Achieve Weight Loss Above or Equal to 3%	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.	After 30 weeks of treatment
Subjects Who Achieve Weight Loss Above or Equal to 5%	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.	After 30 weeks of treatment
Subjects Who Achieve Weight Loss Above or Equal to 10%	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.	After 30 weeks of treatment
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain	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.	After 30 weeks of treatment
Subjects Who Achieve HbA1c Reduction Above or Equal to 1%	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.	After 30 weeks of treatment
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%	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.	After 30 weeks of treatment
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%	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.	After 30 weeks of treatment
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%	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.	After 30 weeks of treatment
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains	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.	Week 0, week 30
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately	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.	Week 0, week 30
Number of Treatment-emergent Adverse Events (TEAE)	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.	Week 0 to week 35
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes	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.	Week 0 to week 35
Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes	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.	Week 0 to week 35
Change in Haematology - Haemoglobin	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.	Week 0, week 30
Change in Haematology - Haematocrit	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.	Week 0, week 30
Change in Haematology - Thrombocytes and Leukocytes	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.	Week 0, week 30
Change in Haematology - Erythrocytes	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.	Week 0, week 30
Change in Biochemistry - Calcium, Pottassium and Sodium	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.	Week 0, week 30
Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.	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.	Week 0, week 30
Change in Biochemistry - Amylase and Lipase	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.	Week 0, week 30
Change in Biochemistry - Creatinine and Bilirubin	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.	Week 0, week 30
Change in Biochemistry - Albumin	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.	Week 0, week 30
Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).	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.	Week 0, week 30
Change in Calcitonin	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.	Week 0, week 30
Change in Pulse Rate	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.	Week 0, week 30

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.
• Capehorn MS, Catarig AM, Furberg JK, Janez A, Price HC, Tadayon S, Verges B, Marre M. Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10). Diabetes Metab. 2020 Apr;46(2):100-109. doi: 10.1016/j.diabet.2019.101117. Epub 2019 Sep 17.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): July 9, 2018
• Study Completion (Actual): August 13, 2018

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NN9535-4339; 2016-004965-22 (Registry Identifier: EudraCT); U1111-1190-5868 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes