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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 446 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00975286
The ClinicalTrials.gov registry entry for NCT00975286 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 446 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00975286 reports 0 study locations.
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.
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