Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010),
in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a
period of 12 weeks of treatment.
The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on
glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin
(HbA1c) reduction (absolute change) at Week 12.
Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on
glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration
regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour
postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and
tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
This is a double-blind, randomized, placebo-controlled, 4-arm, unbalanced design, parallel group study with a two-step titration regimen or a one-step titration regimen. The study is double-blind with regard to active and placebo treatments; however neither the study drug volume nor the titration regimens (that is, two-step or one-step) are blinded. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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