NCT01179048|CompletedPhase 3ResultsDMC

Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results

LEADER®

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

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

EX2211-37482009-012201-19U1111-1113-7090CTR20130003

Study Type

interventional

Target

9,341

Locations

31 countries

Sites

417

Timeline

RegisteredAug 2010

StartedAug 2010

CompletionDec 2015

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

9,341

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Aug 2010

Longer than P75 for phase_3 diabetes

Geographic Reach

31 countries

417 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.3 years study duration

First Submitted

Initial submission to the registry

August 6, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed

21 days until next milestone

Study Start

First participant enrolled

August 31, 2010

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2015

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

March 1, 2017

Completed

Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

5.3 years

First QC Date

August 6, 2010

Results QC Date

December 16, 2016

Last Update Submit

July 3, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
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.
from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Secondary Outcomes (5)

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 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 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)

Study Arms (2)

Liraglutide

EXPERIMENTAL

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

Liraglutide

placeboDRUG

Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

Placebo

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.