Phase 3
Completed N=577
Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03191396 ↗Enrolled (actual)
577
Serious AEs
6.8%
Results posted
Aug 2019
Primary outcomePrimary: Change in HbA1c — -1.7; -1.1 Percentage of glycosylated haemoglobin — p=<0.0001
◆ Published Evidence
Highly cited
401citations · ~67 / year
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).
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.
Linked Publications (2)
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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).
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Once-Weekly Semaglutide Reduces HbA<sub>1c</sub> and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
-1.7; -1.1 | <0.0001 sig |
| SECONDARY Change in Body Weight (kg) |
-5.8; -2.0 | <0.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-2.65; -1.46 | — |
| SECONDARY Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile |
-3.0; -2.1 | — |
| SECONDARY Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals) |
-1.0; -0.4 | — |
| SECONDARY Change in Fasting Blood Lipids: Total Cholesterol |
0.96; 0.98 | — |
| SECONDARY Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol |
0.99; 0.99 | — |
| SECONDARY Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol |
1.01; 0.99 | — |
| SECONDARY Change in Fasting Blood Lipids: Triglycerides |
0.83; 0.91 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-2.0; -0.7 | — |
| SECONDARY Change in Waist Circumference |
-5.2; -2.4 | — |
| SECONDARY Change in Systolic Blood Pressure |
-4.3; -3.7 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-1.5; -1.3 | — |
| SECONDARY Change in Body Weight (%) |
-6.1; -2.0 | — |
| SECONDARY Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target |
80.4; 45.9 | — |
| SECONDARY Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target |
58.5; 24.8 | — |
| SECONDARY Subjects Who Achieve Weight Loss Above or Equal to 3% |
72.7; 33.9 | — |
| SECONDARY Subjects Who Achieve Weight Loss Above or Equal to 5% |
55.9; 17.7 | — |
| SECONDARY Subjects Who Achieve Weight Loss Above or Equal to 10% |
19.1; 4.4 | — |
| SECONDARY Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain |
75.6; 36.8 | — |
| SECONDARY Subjects Who Achieve HbA1c Reduction Above or Equal to 1% |
82.8; 48.3 | — |
| SECONDARY Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3% |
62.4; 20.9 | — |
| SECONDARY Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5% |
49.6; 11.9 | — |
| SECONDARY Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10% |
17.1; 3.6 | — |
| SECONDARY Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains |
1.8; 1.4; 1.4; 0.6; 2.2; 1.5 | — |
| SECONDARY Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately |
0.9; 0.9; -2.1; -1.6; 0.1; 0.1 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAE) |
758; 691 | — |
| SECONDARY Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes |
8; 8 | — |
| SECONDARY Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes |
5; 7 | — |
| SECONDARY Change in Haematology - Haemoglobin |
1.0; 1.0 | — |
| SECONDARY Change in Haematology - Haematocrit |
1.5; 1.1 | — |
| SECONDARY Change in Haematology - Thrombocytes and Leukocytes |
18.4; 21.5; 0.14; 0.14 | — |
| SECONDARY Change in Haematology - Erythrocytes |
0.14; 0.14 | — |
| SECONDARY Change in Biochemistry - Calcium, Pottassium and Sodium |
0.07; 0.07; 0.3; 0.3; 1.8; 1.7 | — |
| SECONDARY Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. |
5.5; 6.4; 5.3; 5.0; 3.5; 3.1 | — |
| SECONDARY Change in Biochemistry - Amylase and Lipase |
10.3; 8.4; 15.8; 14.0 | — |
| SECONDARY Change in Biochemistry - Creatinine and Bilirubin |
4.1; 3.6; 1.9; 2.0 | — |
| SECONDARY Change in Biochemistry - Albumin |
0.2; 0.2 | — |
| SECONDARY Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR). |
4.0; 4.1 | — |
| SECONDARY Change in Calcitonin |
1.3; 1.1 | — |
| SECONDARY Change in Pulse Rate |
2.4; 3.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03191396) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.