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

This study has been completed.
Sponsor:
Collaborator:
Profil GmbH, Neuss, Germany
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00931372
First received: June 30, 2009
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Lixisenatide (AVE0010)
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Area under the insulin secretion curve [ Time Frame: within 10 minutes after I.V. glucose challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the insulin secretion curve [ Time Frame: within 10 to 120 minutes after I.V. glucose challenge ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Lixisenatide (AVE0010)
Solution for subcutaneous injection 100 µg/mL
Drug: Placebo
Subcutaneous injection
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: Lixisenatide (AVE0010)
Solution for subcutaneous injection 100 µg/mL
Drug: Placebo
Subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931372

Locations
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Sponsors and Collaborators
Sanofi
Profil GmbH, Neuss, Germany
Investigators
Principal Investigator: Christoph KAPITZA, MD Profil GmbH, Neuss, Germany
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00931372     History of Changes
Other Study ID Numbers: PDY10433, EudraCT:2008-003242-28
Study First Received: June 30, 2009
Last Updated: February 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Sanofi:
Insulin release
Diabetes mellitus type 2
GLP-1 agonist

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013