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NCT01676220 · ClinicalTrials.gov registry record · Phase 3
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
A Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 878
- Enrollment target
- 20
- Study locations
NCT01676220: Completed Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Sanofi.
NCT01676220 is a Phase 3 study of Type 2 Diabetes Mellitus that has completed, run by Sanofi. The registered enrollment target is 878 participants, below the 2,953-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01676220, a Phase 3 study of Type 2 Diabetes Mellitus, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 878 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of: \- occurrence of nocturnal hypoglycemia
Primary Outcome
Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Conditions Studied
Interventions
- DRUG HOE901-U300 (new formulation of insulin glargine)
- DRUG Lantus (insulin glargine)
Study Locations (20)
California
- Investigational Site Number 840347 - Bell Gardens
- Investigational Site Number 840244 - Escondido
- Investigational Site Number 840257 - Fresno
- Investigational Site Number 840213 - Greenbrae
- Investigational Site Number 840267 - Huntington Beach
- Investigational Site Number 840230 - La Jolla
- Investigational Site Number 840235 - La Mesa
- Investigational Site Number 840274 - La Mesa
- Investigational Site Number 840222 - Long Beach
- Investigational Site Number 840243 - Palm Springs
- Investigational Site Number 840250 - Spring Valley
Arizona
- Investigational Site Number 840273 - Chandler
- Investigational Site Number 840217 - Mesa
- Investigational Site Number 840220 - Peoria
- Investigational Site Number 840211 - Phoenix
- Investigational Site Number 840207 - Phoenix
- Investigational Site Number 840264 - Tempe
- Investigational Site Number 840234 - Tempe
Alabama
- Investigational Site Number 840324 - Montgomery
Arkansas
- Investigational Site Number 840304 - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 878 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01676220 record still lists
NCT01676220 is an interventional study that assigns participants to a tested intervention. The registered 878 participants enrollment target is mid-sized for trials with a published cap, below the 2,953-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which HOE901-U300 (new formulation of insulin glargine) is the first listed.
NCT01676220 names 20 study sites across 4 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT01676220 about?
NCT01676220 is a clinical study titled "Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy". Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine...
What is the current status of trial NCT01676220?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 878 participants. The study started on 2012-08. Estimated completion is 2014-03.
What conditions does trial NCT01676220 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT01676220?
The interventions under investigation include: HOE901-U300 (new formulation of insulin glargine) (DRUG), Lantus (insulin glargine) (DRUG).
Who is sponsoring clinical trial NCT01676220?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01676220 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 Mellitus
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 NCT01676220's enrollment target sits among peer trials
878 15th of 130 higher than 116 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus 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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