Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2
NCT ID: NCT00931372
Last Updated: 2012-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2009-06-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Sequence 1: AVE0010/Placebo
Period 1: lixisenatide 20 µg in 200 µL, one single dose
Period 2: placebo 200 µL, one single dose
Lixisenatide (AVE0010)
Solution for subcutaneous injection 100 µg/mL
Placebo
Subcutaneous injection
Sequence 2: Placebo/AVE0010
Period 1: placebo 200 µL, one single dose
Period 2: lixisenatide 20 µg in 200 µL, one single dose
Lixisenatide (AVE0010)
Solution for subcutaneous injection 100 µg/mL
Placebo
Subcutaneous injection
Interventions
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Lixisenatide (AVE0010)
Solution for subcutaneous injection 100 µg/mL
Placebo
Subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Profil GmbH, Neuss, Germany
UNKNOWN
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Christoph KAPITZA, MD
Role: PRINCIPAL_INVESTIGATOR
Profil GmbH, Neuss, Germany
Locations
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Sanofi-Aventis Administrative Office
Berlin, , Germany
Countries
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Other Identifiers
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EudraCT:2008-003242-28
Identifier Type: -
Identifier Source: secondary_id
PDY10433
Identifier Type: -
Identifier Source: org_study_id
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