Phase 3
Completed N=3,297
Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01720446 ↗Enrolled (actual)
3,297
Serious AEs
36.2%
Results posted
Mar 2018
Primary outcomePrimary: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke — 6.6; 8.9 percentage of subjects — p=<0.0001
◆ Published Evidence
Highly cited
6,525citations · ~653 / year
Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.
Summary
This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.
Linked Publications (5)
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Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.
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Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy.
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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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Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial.
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Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke |
6.6; 8.9 | <0.0001 sig |
| SECONDARY Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome |
12.1; 16.0 | 0.0016 sig |
| SECONDARY Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome |
1.6; 1.9; 2.5; 3.7; 1.5; 2.5 | 0.9181 |
| SECONDARY Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke |
7.4; 9.6 | 0.0292 sig |
| SECONDARY Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c) |
-1.09; -1.41; -0.44; -0.36 | <0.0001 sig |
| SECONDARY Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose |
-1.75; -2.11; -1.02; -0.88 | <0.0001 sig |
| SECONDARY Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight |
-3.57; -4.88; -0.62 | <0.0001 sig |
| SECONDARY Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile |
0.97; 0.97; 1.00; 0.99; 0.99; 1.01 | 0.0149 sig |
| SECONDARY Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio |
1.02; 0.91; 1.32; 1.29 | 0.0003 sig |
| SECONDARY Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs |
-1.37; -1.57; -1.42; -1.71; -3.44; -5.37 | 0.9205 |
| SECONDARY Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events |
37.5; 36.2; 35.3; 39.7 | — |
| SECONDARY Incidence During the Trial in Other Treatment Outcomes: Adverse Events |
330.5; 337.0; 317.4; 298.3 | — |
| SECONDARY Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies |
1.4; 2.3 | — |
| SECONDARY Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO) |
0.66; 1.82; 0.16; 0.35; 1.66; 2.55 | 0.3171 |
| SECONDARY Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids) |
0.95; 0.91; 0.96; 0.99 | 0.7796 |
| SECONDARY Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate) |
2.12; 2.41; 0.09; -0.07 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria: - Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c above or equal to 7.0% at screening Exclusion Criteria: - Type 1 diabetes mellitus - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening - Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma - Screening calcitonin above or equal to 50 ng/L
Data sourced from ClinicalTrials.gov (NCT01720446) 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.