Type 2 Diabetes Clinical Trial
Official title:
A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)
Primary Objective:
To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone
and to insulin glargine alone (on top of metformin treatment) 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 alone and to lixisenatide alone (on top of metformin
treatment) over a 30 week treatment period in patients with type 2 diabetes
Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days follow-up period. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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