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NCT01517412 · ClinicalTrials.gov registry record · Phase 3
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 451
- Enrollment target
NCT01517412 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 451 participants.
The verdict
NCT01517412, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 451 participants
- Enrollment target
Study Summary
Primary Objective: \- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: * To assess the effect of the 2 lixisenatide regimens on: * The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24 * Fasting Plasma Glucose (FPG) * 7-point Self-Monitored Plasma Glucose (SMPG) profiles * Body weight * To assess the safety and tolerability of the 2 lixisenatide regimens
Interventions
- DRUG Metformin
- DRUG Lixisenatide (AVE0010)
- DEVICE Self-injector pen device (OptiClik®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01517412
The ClinicalTrials.gov registry entry for NCT01517412 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 451 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 3 interventions - of which Metformin is the first listed.
NCT01517412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01517412 about?
NCT01517412 is a clinical study titled "Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin". Primary Objective: \- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: * To assess the effect of the 2 lixisenatide regimens on: * The percentage of participants who reached the target of HbA1c ...
What is the current status of trial NCT01517412?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2012-02. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01517412?
The interventions under investigation include: Metformin (DRUG), Lixisenatide (AVE0010) (DRUG), Self-injector pen device (OptiClik®) (DEVICE).
Who is sponsoring clinical trial NCT01517412?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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