Phase 3
Completed N=9,340
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
Source: ClinicalTrials.gov NCT01179048 ↗Enrolled (actual)
9,340
Serious AEs
50.0%
Results posted
Mar 2017
Primary outcomePrimary: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) — 13.0; 14.9 percentage of subjects — p=<0.001
◆ Published Evidence
Highly cited
7,289citations · ~729 / year
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.
Summary
This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.
Linked Publications (5)
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Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.
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LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial.
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LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial.
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LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ.
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LEADER-6: Baseline renal function and associated factors in a high cardiovascular risk type 2 diabetes population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) |
13.0; 14.9 | <0.001 sig |
| SECONDARY Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure. |
20.3; 22.7 | — |
| SECONDARY Time From Randomisation to All Cause Death |
8.2; 9.6 | — |
| SECONDARY Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome |
4.7; 6.0; 3.4; 3.8; 6.0; 6.8 | — |
| SECONDARY Time From Randomisation to First Occurrence of a Composite Microvascular Outcome |
7.6; 8.9 | — |
| SECONDARY Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately. |
5.7; 7.2; 3.4; 4.6; 1.9; 2.1 | — |
Eligibility Criteria
Inclusion Criteria: - Type 2 diabetes - Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s) Exclusion Criteria: - Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigator's discretion
Data sourced from ClinicalTrials.gov (NCT01179048) 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.