Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

PHASE2CompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Lixisenatide (AVE0010)

"Pharmaceutical form: solution for injection self-administered with a pen-like injector (OptiClik®).~Route of administration: subcutaneous"

DRUG

Liraglutide

"Pharmaceutical form:solution for injection~Route of administration: subcutaneous"

DRUG

Insulin Glargine

Doses to be adjusted to maintain a fasting self-measured plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL)

DRUG

Metformin

If previously taken metformin to be continued at stable dose throughout the study

Trial Locations (8)

10117

Investigational Site Number 276008, Berlin

14050

Investigational Site Number 276006, Berlin

24105

Investigational Site Number 276004, Kiel

41061

Investigational Site Number 276005, Mönchengladbach

41460

Investigational Site Number 276001, Neuss

55116

Investigational Site Number 276002, Mainz

80636

Investigational Site Number 276007, München

89231

Investigational Site Number 276003, Neu-Ulm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT01596504 - Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin | Biotech Hunter | Biotech Hunter