Diabetes Mellitus Type 2 Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010),
in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin,
over a period of 24 weeks of treatment, followed by an extension.
The primary objective is to assess the effects of lixisenatide when added to pioglitazone on
glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at
Week 24.
Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on
the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to
6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic
model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to
assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody
development.
Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the schedule date of Week 76 visit (Visit 25) for the last randomized patients. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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