Phase 3
Completed N=1,082
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02128932 ↗Enrolled (actual)
1,082
Serious AEs
5.3%
Results posted
Mar 2018
Primary outcomePrimary: Change in HbA1c From Baseline — -1.21; -1.64; -0.83 percentage — p=<0.0001
◆ Published Evidence
Highly cited
437citations · ~49 / year
Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial.
Summary
This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.
Linked Publications (5)
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Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial.
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Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials.
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Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial.
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Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials.
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Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline |
-1.21; -1.64; -0.83 | <0.0001 sig |
| SECONDARY Change in Body Weight From Baseline |
-3.47; -5.17; 1.15 | — |
| SECONDARY Change in Fasting Plasma Glucose From Baseline |
-36.74; -49.21; -38.18 | — |
| SECONDARY Change in Diastolic Blood Pressure. |
-1.38; -0.98; -1.44 | — |
| SECONDARY Change in Systolic Blood Pressure. |
-4.65; -5.17; -1.68 | — |
| SECONDARY Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ |
0.95; 1.76; 0.90; 1.95; 2.78; 1.63 | — |
| SECONDARY Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs) |
4.86; 5.37; 3.99 | — |
| SECONDARY Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) |
135; 195; 63; 227; 165; 297 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years or older at the time of signing informed consent
- Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
- HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Exclusion Criteria
- Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
- Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
- Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
- History of chronic or idiopathic acute pancreatitis
- Screening calcitonin value greater than or equal to 50 ng/L
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
- Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
- Acute coronary or cerebrovascular event within 90 days before randomisation
- Heart failure, New York Heart Association Class IV
- Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
- Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Data sourced from ClinicalTrials.gov (NCT02128932) 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.