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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: Completed Phase 3 study, sponsored by Sanofi.
NCT02058147 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,170 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine. Change in HbA1c was calculated by subtracting baseline value from Week 30 value.
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 |
What the finished NCT02058147 record still lists
NCT02058147 is an interventional study that assigns participants to a tested intervention. Its 1,170 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT02058147 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02058147's enrollment target sits among peer trials
1,170 236th of 2000 higher than 1,764 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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