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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

June 30, 2009
February 22, 2012
June 2009
August 2009   (final data collection date for primary outcome measure)
Area under the insulin secretion curve [ Time Frame: within 10 minutes after I.V. glucose challenge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00931372 on ClinicalTrials.gov Archive Site
Area under the insulin secretion curve [ Time Frame: within 10 to 120 minutes after I.V. glucose challenge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Lixisenatide (AVE0010)
    Solution for subcutaneous injection 100 µg/mL
  • Drug: Placebo
    Subcutaneous injection
  • Experimental: Sequence 1: AVE0010/Placebo

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

    Period 2: placebo 200 µL, one single dose

    Interventions:
    • Drug: Lixisenatide (AVE0010)
    • Drug: Placebo
  • Experimental: Sequence 2: Placebo/AVE0010

    Period 1: placebo 200 µL, one single dose

    Period 2: lixisenatide 20 µg in 200 µL, one single dose

    Interventions:
    • Drug: Lixisenatide (AVE0010)
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00931372
PDY10433, EudraCT:2008-003242-28
No
Sanofi
Sanofi
Profil GmbH, Neuss, Germany
Principal Investigator: Christoph KAPITZA, MD Profil GmbH, Neuss, Germany
Sanofi
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP