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NCT02058160 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
A Phase 3 study of Type 2 Diabetes, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 736
- Enrollment target
- 20
- Study locations
NCT02058160: Completed Phase 3 study of Type 2 Diabetes, sponsored by Sanofi.
NCT02058160 is a Phase 3 study of Type 2 Diabetes that has completed, run by Sanofi. The registered enrollment target is 736 participants, below the 3,921-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02058160, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 736 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.
Primary Outcome
Change in HbA1c was calculated by subtracting baseline value from Week 30 value.
Conditions Studied
Interventions
- DRUG Insulin glargine/lixisenatide (HOE901/AVE0010)
- DRUG Insulin glargine (HOE901)
- DRUG Metformin (Background Drug)
Study Locations (20)
California
- Investigational Site Number 840568 - Bell Gardens
- Investigational Site Number 840550 - Chino
- Investigational Site Number 840529 - Chula Vista
- Investigational Site Number 840623 - Corona
- Investigational Site Number 840566 - Fresno
- Investigational Site Number 840552 - Greenbrae
- Investigational Site Number 840578 - Lancaster
- Investigational Site Number 840626 - Los Angeles
- Investigational Site Number 840581 - Los Angeles
- Investigational Site Number 840621 - Mission Viejo
- Investigational Site Number 840511 - Northridge
- Investigational Site Number 840573 - Palm Springs
- Investigational Site Number 840559 - Port Hueneme
- Investigational Site Number 840536 - San Ramon
Arizona
- Investigational Site Number 840570 - Sun City
- Investigational Site Number 840562 - Tempe
- Investigational Site Number 840577 - Tucson
Arkansas
- Investigational Site Number 840517 - Little Rock
- Investigational Site Number 840537 - Little Rock
Alabama
- Investigational Site Number 840607 - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 736 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT02058160 record still lists
NCT02058160 is an interventional study that assigns participants to a tested intervention. The registered 736 participants enrollment target is mid-sized for trials with a published cap, below the 3,921-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Insulin glargine/lixisenatide (HOE901/AVE0010) is the first listed.
NCT02058160 names 20 study sites across 4 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02058160 about?
NCT02058160 is a clinical study titled "Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes". Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide...
What is the current status of trial NCT02058160?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 736 participants. The study started on 2014-01. Estimated completion is 2015-07.
What conditions does trial NCT02058160 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT02058160?
The interventions under investigation include: Insulin glargine/lixisenatide (HOE901/AVE0010) (DRUG), Insulin glargine (HOE901) (DRUG), Metformin (Background Drug) (DRUG).
Who is sponsoring clinical trial NCT02058160?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02058160 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02058160's enrollment target sits among peer trials
736 34th of 327 higher than 294 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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.
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