Phase 3
Completed N=1,201
Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.
Source: ClinicalTrials.gov NCT02648204 ↗Enrolled (actual)
1,201
Serious AEs
7.2%
Results posted
May 2018
Primary outcomePrimary: Change in HbA1c — -1.51; -1.78; -1.11; -1.37 percentage of HbA1c — p=<0.0001
◆ Published Evidence
Highly cited
758citations · ~95 / year
Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.
Summary
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.
Linked Publications (5)
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Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.
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Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.
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Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials.
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Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis.
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Cost of Achieving HbA1c Treatment Targets and Weight Loss Responses with Once-Weekly Semaglutide Versus Dulaglutide in the United States.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
-1.51; -1.78; -1.11; -1.37 | <0.0001 sig |
| SECONDARY Change in Body Weight (kg) |
-4.56; -6.53; -2.30; -2.98 | <0.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose |
-2.18; -2.83; -1.87; -2.25 | — |
| SECONDARY Change in Systolic and Diastolic Blood Pressure |
-0.57; -2.05; -0.35; -0.03; -2.44; -4.88 | — |
| SECONDARY Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire |
4.60; 4.55; 4.52; 4.65 | — |
| SECONDARY HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target |
49.2; 66.7; 34.1; 47.2; 50.8; 33.3 | — |
| SECONDARY Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile |
-2.43; -2.95; -1.99; -2.32 | — |
| SECONDARY Change From Baseline 7-point Self-measured Plasma Glucose Increment |
-0.77; -0.93; -0.44; -0.63 | — |
| SECONDARY Change in Fasting Blood Lipids (Total Cholesterol) |
0.96; 0.97; 0.97; 0.99 | — |
| SECONDARY Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) |
0.97; 1.00; 0.97; 1.01 | — |
| SECONDARY Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) |
0.99; 1.01; 1.00; 1.02 | — |
| SECONDARY Change in Fasting Blood Lipids (Triglycerides) |
0.91; 0.86; 0.91; 0.90 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-1.63; -2.33; -0.82; -1.08 | — |
| SECONDARY Change in Waist Circumference |
-4.27; -5.20; -2.36; -2.93 | — |
| SECONDARY Change in Short Form Health Survey (SF-36v2™) |
1.21; 2.04; 1.93; 1.29; 1.45; 1.23 | — |
| SECONDARY Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target |
68.4; 78.7; 52.2; 66.6; 31.6; 21.3 | — |
| SECONDARY Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% |
43.9; 63.0; 22.7; 30.2; 56.1; 37.0 | — |
| SECONDARY Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% |
14.3; 26.7; 3.3; 7.7; 85.7; 73.3 | — |
| SECONDARY Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain |
64.5; 74.0; 44.1; 58.4; 35.5; 26.0 | — |
| SECONDARY Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% |
77.4; 83.3; 53.8; 67.6; 22.6; 16.7 | — |
| SECONDARY Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% |
64.5; 76.7; 36.5; 44.6; 35.5; 23.3 | — |
| SECONDARY Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% |
53.2; 68.3; 25.1; 34.9; 46.8; 31.7 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAEs) |
966; 1015; 802; 957 | — |
| SECONDARY Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes |
3; 7; 3; 5 | — |
| SECONDARY Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes |
0.7; 1.7; 1.0; 1.7 | — |
| SECONDARY Change in Amylase |
1.17; 1.22; 1.16; 1.20 | — |
| SECONDARY Change in Lipase |
1.22; 1.32; 1.23; 1.29 | — |
| SECONDARY Change in Pulse Rate |
2.09; 3.96; 1.56; 2.42 | — |
Eligibility Criteria
Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Data sourced from ClinicalTrials.gov (NCT02648204) 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.