Phase 3
Completed N=7,637
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
Source: ClinicalTrials.gov NCT01959529 ↗Enrolled (actual)
7,637
Serious AEs
39.2%
Results posted
Nov 2017
Primary outcomePrimary: Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke — 325; 356; 143; 163 Participants — p=<0.001
◆ Published Evidence
Highly cited
566citations · ~63 / year
Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes.
Summary
This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.
Linked Publications (5)
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Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes.
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Day-to-day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2).
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DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality.
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Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) - DEVOTE 1.
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DEVOTE 5: Evaluating the Short-Term Cost-Utility of Insulin Degludec Versus Insulin Glargine U100 in Basal-Bolus Regimens for Type 2 Diabetes in the UK.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke |
325; 356; 143; 163; 68; 74 | <0.001 sig |
| SECONDARY Number of EAC-confirmed Severe Hypoglycaemic Episodes |
280; 472 | <0.001 sig |
| SECONDARY Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no) |
187; 252 | <0.001 sig |
| SECONDARY Change in Glycosylated Haemoglobin (HbA1c) |
-0.86; -0.84 | — |
Eligibility Criteria
Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s) Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA (New York Heart Association) class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
Data sourced from ClinicalTrials.gov (NCT01959529) 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.