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24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

NCT00976937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2016-10-11

Study results available
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Summary

The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index \[BMI\] greater than or equal to 30 kilogram per square meter \[kg/m\^2\]) type 2 diabetic patients less than 50 years of age, over a period of 24 weeks of treatment.

The primary objective of this study is to assess the efficacy of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24.

Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on absolute changes in HbA1c values and body weight; fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and anti-lixisenatide antibody development.

Conditions

Interventions

DRUG

Lixisenatide (AVE0010)

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

DRUG

Lixisenatide Placebo

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

DEVICE

Pen auto-injector

DRUG

Sitagliptin

Administered orally once a day in the morning with or without food at approximately the same time each day.

DRUG

Sitagliptin Placebo

Administered orally once a day in the morning with or without food at approximately the same time each day.

DRUG

Metformin

Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Chile
  • Germany
  • Guatemala
  • Mexico
  • Peru
  • Poland
  • Romania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00976937 on ClinicalTrials.gov