Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo
- Registration Number
- NCT00931372
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1: AVE0010/Placebo Lixisenatide (AVE0010) Period 1: lixisenatide 20 µg in 200 µL, one single dose Period 2: placebo 200 µL, one single dose Sequence 2: Placebo/AVE0010 Lixisenatide (AVE0010) Period 1: placebo 200 µL, one single dose Period 2: lixisenatide 20 µg in 200 µL, one single dose Sequence 1: AVE0010/Placebo Placebo Period 1: lixisenatide 20 µg in 200 µL, one single dose Period 2: placebo 200 µL, one single dose Sequence 2: Placebo/AVE0010 Placebo Period 1: placebo 200 µL, one single dose Period 2: lixisenatide 20 µg in 200 µL, one single dose
- Primary Outcome Measures
Name Time Method Area under the insulin secretion curve within 10 minutes after I.V. glucose challenge
- Secondary Outcome Measures
Name Time Method Area under the insulin secretion curve within 10 to 120 minutes after I.V. glucose challenge
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇩🇪Berlin, Germany