| Trial ID: | L2922 |
| Source ID: | NCT00931372
|
| Associated Drug: |
Lixisenatide (Ave0010)
|
| Title: |
Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2
|
| Acronym: |
RESTORE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Lixisenatide (AVE0010)|DRUG: Placebo
|
| Outcome Measures: |
Primary: Area under the insulin secretion curve, within 10 minutes after I.V. glucose challenge | Secondary: Area under the insulin secretion curve, within 10 to 120 minutes after I.V. glucose challenge
|
| Sponsor/Collaborators: |
Sponsor: Sanofi | Collaborators: Profil GmbH, Neuss, Germany
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-06
|
| Completion Date: |
2009-08
|
| Results First Posted: |
|
| Last Update Posted: |
2012-02-23
|
| Locations: |
Sanofi-Aventis Administrative Office, Berlin, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00931372
|
