Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-L)

Primary Objective:
- To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine in HbA1c change from baseline to week 30.

Secondary Objective:
- To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine (with or without metformin) over a 30 week treatment period in patients with type 2 diabetes


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With T2DM
Enrollment: 736
Study Start Date: January 2014
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Insulin glargine/lixisenatide fixed ratio combination
- Active Comparator: Insulin glargine