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NCT02058147 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,170
- Enrollment target
NCT02058147 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,170 participants.
The verdict
NCT02058147, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,170 participants
- Enrollment target
Study Summary
Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.
Interventions
- DRUG Metformin
- DRUG Insulin glargine (HOE901)
- DRUG Lixisenatide (AVE0010)
- DRUG Insulin glargine/lixisenatide Fixed Ratio Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,170 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02058147
The ClinicalTrials.gov registry entry for NCT02058147 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,170 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 4 interventions - of which Metformin is the first listed.
NCT02058147 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02058147 about?
NCT02058147 is a clinical study titled "Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM". Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safe...
What is the current status of trial NCT02058147?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,170 participants. The study started on 2014-02. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02058147?
The interventions under investigation include: Metformin (DRUG), Insulin glargine (HOE901) (DRUG), Lixisenatide (AVE0010) (DRUG), Insulin glargine/lixisenatide Fixed Ratio Combination (DRUG).
Who is sponsoring clinical trial NCT02058147?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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