GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin

PHASE3CompletedINTERVENTIONAL
Enrollment

496

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

February 28, 2011

Study Completion Date

February 28, 2011

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Lixisenatide (AVE0010)

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

DRUG

Placebo

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

DRUG

Basal Insulin

Dose to be kept stable.

DRUG

Metformin

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

DEVICE

Pen auto-injector

Trial Locations (15)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, São Paulo

Sanofi-Aventis Administrative Office, Laval

Sanofi-Aventis Administrative Office, Santiago

Sanofi-Aventis Administrative Office, Cairo

Sanofi-Aventis Administrative Office, Paris

Sanofi-Aventis Administrative Office, Berlin

Sanofi-Aventis Administrative Office, Mumbai

Sanofi-Aventis Administrative Office, Milan

Sanofi-Aventis Administrative Office, México

Sanofi-Aventis Administrative Office, San Juan

Sanofi-Aventis Administrative Office, Moscow

Sanofi-Aventis Administrative Office, Seoul

Sanofi-Aventis Administrative Office, Istanbul

Sanofi-Aventis Administrative Office, Guildford Surrey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY