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NCT00763451 · ClinicalTrials.gov registry record · Phase 3
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 484
- Enrollment target
- 15
- Study locations
NCT00763451 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Sanofi. The registered enrollment target is 484 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The trial reports 15 study locations across 2 states.
The verdict
NCT00763451, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 484 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Lixisenatide (AVE0010)
- DEVICE Pen auto-injector
Study Locations (15)
Other
- Sanofi-Aventis Administrative Office - São Paulo
- Sanofi-Aventis Administrative Office - Santiago
- Sanofi-Aventis Administrative Office - Bogotá
- Sanofi-Aventis Administrative Office - Tallinn
- Sanofi-Aventis Administrative Office - Berlin
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Vilnius
- Sanofi-Aventis Administrative Office - Kuala Lumpur
- Sanofi-Aventis Administrative Office - México
- Sanofi-Aventis Administrative Office - Makati City
- Sanofi-Aventis Administrative Office - Warsaw
- Sanofi-Aventis Administrative Office - Bucharest
- Sanofi-Aventis Administrative Office - Brastislava
- Sanofi-Aventis Administrative Office - Kiev
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2008-09 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00763451
The ClinicalTrials.gov registry entry for NCT00763451 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00763451 reports 15 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00763451 about?
NCT00763451 is a clinical study titled "GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin". The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to me...
What is the current status of trial NCT00763451?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 484 participants. The study started on 2008-09. Estimated completion is 2011-01.
What conditions does trial NCT00763451 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT00763451?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Lixisenatide (AVE0010) (DRUG), Pen auto-injector (DEVICE).
Who is sponsoring clinical trial NCT00763451?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00763451 being conducted?
This trial has 15 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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