NCT00713830 - GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea | Biotech Hunter

Enrollment

859

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 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.

DEVICE

Pen auto-injector

DRUG

Sulfonylurea

Sulfonylurea to be continued at maximum effective dose according to local labeling up to end of treatment.

DRUG

Metformin

Metformin if given to be continued at stable dose (at least 1.5 gram per day \[except at least 0.75 gram per day in Japan and 1.0 gram per day in South Korea\]) up to the end of treatment.

Trial Locations (16)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, Sofia

Sanofi-Aventis Administrative Office, Prague

Sanofi-Aventis Administrative Office, Cairo

Sanofi-Aventis Administrative Office, Berlin

Sanofi-Aventis Administrative Office, Mumbai

Sanofi-Aventis Administrative Office, Netanya

Sanofi-Aventis Administrative Office, Tokyo

Sanofi-Aventis Administrative Office, Gouda

Sanofi-Aventis Administrative Office, Bucharest

Sanofi-Aventis Administrative Office, Moscow

Sanofi-Aventis Administrative Office, Seoul

Sanofi-Aventis Administrative Office, Taipei

Sanofi-Aventis Administrative Office, Bangkok

Sanofi-Aventis Administrative Office, Mégrine

Sanofi-Aventis Administrative Office, Istanbul