GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

680

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Lixisenatide (AVE0010)

Self administered by subcutaneous injections once daily within the hour preceding meal (either breakfast or dinner).

DRUG

Placebo

Self administered by subcutaneous injections once daily within the hour preceding meal (either breakfast or dinner).

DEVICE

Pen auto-injector

DRUG

Metformin

Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Trial Locations (16)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

sanofi-aventis Australia & New Zealand administrative office, Macquarie Park

Sanofi-Aventis Administrative Office, Laval

Sanofi-Aventis Administrative Office, Santiago

Sanofi-Aventis Administrative Office, Zagreb

Sanofi-Aventis Administrative Office, Prague

Sanofi-Aventis Administrative Office, Berlin

Sanofi-Aventis Administrative Office, México

Sanofi-Aventis Administrative Office, Casablanca

Sanofi-Aventis Administrative Office, Makati City

Sanofi-Aventis Administrative Office, Bucharest

Sanofi-Aventis Administrative Office, Moscow

Sanofi-Aventis Administrative Office, Midrand

Sanofi-Aventis Administrative Office, Barcelona

Sanofi-Aventis Administrative Office, Kiev

Sanofi-Aventis Administrative Office, Caracas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY