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GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

NCT00763815 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2016-11-28

Study results available
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Summary

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.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Lixisenatide (AVE0010)

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

DRUG

Placebo

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

DEVICE

Pen auto-injector

DRUG

Pioglitazone

Dose to be kept stable.

DRUG

Metformin

Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States
  • Austria
  • Canada
  • France
  • Germany
  • Greece
  • Guatemala
  • India
  • Mexico
  • Peru
  • Puerto Rico
  • Romania
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00763815 on ClinicalTrials.gov