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Completed

NCT Number: NCT00931372

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lixisenatide (AVE0010)

Drug

Solution for subcutaneous injection 100 µg/mL

Placebo

Drug

Subcutaneous injection

Primary outcomes

  1. Area under the insulin secretion curve

    Time frame: within 10 minutes after I.V. glucose challenge

Secondary outcomes

  1. Area under the insulin secretion curve

    Time frame: within 10 to 120 minutes after I.V. glucose challenge

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Profil GmbH, Neuss, Germany

Registry information

Official study title

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.

Acronym: RESTORE

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 2, 2009
Registry last updated
Feb 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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