Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2 (RESTORE)

February 22, 2012 updated by: Sanofi

Restoration of First Phase Insulin Release in Subjects With Type 2 Diabetes Mellitus With Subcutaneous Injection of 20 µg AVE0010 in a Double-blind, Randomized, Placebo-controlled, Two-way Cross Over Intravenous Glucose Challenge Study.

The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin
  • HbA1c>=6,0 % and <=8,5 % at screening
  • BMI 25 to 35 kg/m²
  • 155>=BP systolic >=90 mmHg
  • 100>=BP diastolic>=45 mmHg

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sequence 1: AVE0010/Placebo

Period 1: lixisenatide 20 µg in 200 µL, one single dose

Period 2: placebo 200 µL, one single dose
Drug: Placebo
Subcutaneous injection
Drug: Lixisenatide (AVE0010)
Solution for subcutaneous injection 100 µg/mL
EXPERIMENTAL: Sequence 2: Placebo/AVE0010

Period 1: placebo 200 µL, one single dose

Period 2: lixisenatide 20 µg in 200 µL, one single dose
Drug: Placebo
Subcutaneous injection
Drug: Lixisenatide (AVE0010)
Solution for subcutaneous injection 100 µg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the insulin secretion curve
Time Frame: within 10 minutes after I.V. glucose challenge
within 10 minutes after I.V. glucose challenge

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the insulin secretion curve
Time Frame: within 10 to 120 minutes after I.V. glucose challenge
within 10 to 120 minutes after I.V. glucose challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Profil GmbH, Neuss, Germany

Investigators

  • Principal Investigator: Christoph KAPITZA, MD, Profil GmbH, Neuss, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (ESTIMATE)

July 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDY10433
  • EudraCT:2008-003242-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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