A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

Novo Nordisk A/S1 site in 1 country9,341 target enrollmentAugust 31, 2010

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsliraglutide placebo

Drugsliraglutide placebo

Overview

Phase: Phase 3
Intervention: liraglutide
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 9341
Locations: 1
Primary Endpoint: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 31, 2010

End Date

December 17, 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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

Arms & Interventions

Liraglutide

Intervention: liraglutide

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.

Secondary Outcomes

Time From Randomisation to All Cause Death(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
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.(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
Time From Randomisation to First Occurrence of a Composite Microvascular Outcome(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))