An Open-label, Randomized, Three-parallel-group Study on Pharmacodynamic Effects of 8-week QD Treatment With Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

Registration

Registration

NCT01596504

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

NONE

Status

COMPLETED

Enrollment

142

Start

2012-05

Primary completion

2013-07

Lead sponsor

Sanofi

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG:Lixisenatide (AVE0010); DRUG:Liraglutide; DRUG:Insulin Glargine; DRUG:Metformin

Results posted

TRUE

Secondary identifiers

EUDRACT_NUMBER:2012-000027-40; OTHER:U1111-1124-1364

Registered primary outcomes

• Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours [0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56]