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NCT00975286 · ClinicalTrials.gov registry record · Phase 3
24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 446
- Enrollment target
NCT00975286: Completed Phase 3 study, sponsored by Sanofi.
NCT00975286 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 446 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00975286, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 446 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (\<) 7 percent (%) and less than or equal to (\<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.
Primary Outcome
Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Insulin glargine
- DRUG Lixisenatide (AVE0010)
- DEVICE Pen auto-injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 446 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT00975286 record still lists
NCT00975286 is an interventional study that assigns participants to a tested intervention. The registered 446 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00975286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00975286 about?
NCT00975286 is a clinical study titled "24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine". The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effe...
What is the current status of trial NCT00975286?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 446 participants. The study started on 2009-10. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00975286?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Insulin glargine (DRUG), Lixisenatide (AVE0010) (DRUG), Pen auto-injector (DEVICE).
Who is sponsoring clinical trial NCT00975286?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00975286's enrollment target sits among peer trials
446 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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