DRUG
Lixisenatide (AVE0010)
Solution for subcutaneous injection 100 µg/mL
Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 1
Enrollment
22
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Subcutaneous injection
Timeline
From registration to results.
First posted
Jul 2, 2009
Study start
Jun 2009
Primary completion
Aug 2009
Study completion
Aug 2009
Results posted
Not reported
Registry updated
Feb 23, 2012
Outcomes
What the study measures.
Primary outcomes
Area under the insulin secretion curve
Time frame · within 10 minutes after I.V. glucose challenge
Secondary outcomes
Area under the insulin secretion curve
Time frame · within 10 to 120 minutes after I.V. glucose challenge
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Sanofi-Aventis Administrative Office
Berlin, Germany
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Lixisenatide.
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Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease
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Put the record in context.
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