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NCT01683266 · ClinicalTrials.gov registry record · Phase 3
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
A Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 549
- Enrollment target
- 20
- Study locations
NCT01683266 is a Phase 3 study of Type 1 Diabetes Mellitus that has completed, run by Sanofi. The registered enrollment target is 549 participants, above the 135-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (307% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT01683266, a Phase 3 study of Type 1 Diabetes Mellitus, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 549 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: * To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus Secondary Objective: * To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of: * Change of HbA1c from baseline to endpoint (scheduled Month 6) * Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM) * Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia) * Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative) * Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period
Conditions Studied
Interventions
- DRUG HOE901-U300 (Insulin glargine new formulation)
- DRUG Lantus (Insulin glargine)
Study Locations (20)
California
- Investigational Site Number 840430 - Bell Gardens
- Investigational Site Number 840131 - Escondido
- Investigational Site Number 840140 - Fresno
- Investigational Site Number 840107 - Greenbrae
- Investigational Site Number 840149 - Huntington Beach
- Investigational Site Number 840120 - La Jolla
- Investigational Site Number 840123 - La Mesa
- Investigational Site Number 840159 - La Mesa
- Investigational Site Number 840114 - Long Beach
- Investigational Site Number 840189 - Mission Hills
- Investigational Site Number 840105 - Temecula
- Investigational Site Number 840155 - Tustin
- Investigational Site Number 840115 - Walnut Creek
Colorado
- Investigational Site Number 840160 - Denver
- Investigational Site Number 840188 - Denver
Florida
- Investigational Site Number 840113 - Bradenton
- Investigational Site Number 840102 - Hialeah
Arizona
- Investigational Site Number 840156 - Chandler
Arkansas
- Investigational Site Number 840177 - Little Rock
Connecticut
- Investigational Site Number 840196 - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 549 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01683266
The ClinicalTrials.gov registry entry for NCT01683266 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 549 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 135-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (307% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which HOE901-U300 (Insulin glargine new formulation) is the first listed.
NCT01683266 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01683266 about?
NCT01683266 is a clinical study titled "Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus". Primary Objective: * To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus Secondary Objective: * To compare HOE90...
What is the current status of trial NCT01683266?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 549 participants. The study started on 2012-09. Estimated completion is 2014-03.
What conditions does trial NCT01683266 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01683266?
The interventions under investigation include: HOE901-U300 (Insulin glargine new formulation) (DRUG), Lantus (Insulin glargine) (DRUG).
Who is sponsoring clinical trial NCT01683266?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01683266 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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