Status:
COMPLETED
Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Profil GmbH, Neuss, Germany
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00931372
Start Date
June 1 2009
End Date
August 1 2009
Last Update
February 23 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Berlin, Germany