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EAGLE: Insulin Glargine vs Liraglutide in T2D

NCT01117350Phase 4

Key facts

Status: Completed
Start: Jul 2010
Primary completion: Oct 2012
Countries: 17
Sponsor: Sanofi
Modality: Recombinant Proteins and Enzymes

Drugs: insulin glargine
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 4, randomised, open-label trial of insulin glargine in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Sanofi. Primary endpoint: Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at 24 weeks. Started Jul 2010; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Insulin Glargine
Insulin glargine once daily + Metformin
Liraglutide
Liraglutide once daily + Metformin

Who it enrols

Patients with Type 2 Diabetes diagnosed for at least 1 year, treated with lifestyle interventions and metformin (plus optionally sulfonylurea, glinide or DPP-4 inhibitor) for >3 months, with HbA1c 7.5-12% and BMI 25-40 kg/m2.

Endpoints

Primary

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7%24 weeks

Secondary

Change in Glycosylated Haemoglobin (HbA1c)24 weeks
Change in Fasting Plasma Glucose24 weeks
Change in Body Weight24 weeks
Hypoglycemia Occurrence24 weeks

Results

Not all primary endpoints met

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