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NCT02688933 · ClinicalTrials.gov registry record · Phase 4
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 638
- Enrollment target
NCT02688933: Completed Phase 4 study, sponsored by Sanofi.
NCT02688933 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 638 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02688933, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 638 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus. Secondary Objective: To demonstrate that treatment with HOE901-U300 compared to Lantus provides: * Lower incidence rate of nocturnal symptomatic hypoglycemia; * Better glucose control coverage during the last hours of CGM before next basal-insulin dosing; * Less variability in CGM profile.
Primary Outcome
The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).
Interventions
- DRUG HOE901-U300 (Insulin Glargine 300 U/ml)
- DRUG Lantus (Insulin Glargine 100 U/ml)
- DRUG Mandated back ground therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 638 participants |
| Start Date | 2016-05-05 |
| Est. Completion | 2017-06-19 |
| Phase | Phase 4 |
What the finished NCT02688933 record still lists
NCT02688933 is an interventional study that assigns participants to a tested intervention. The registered 638 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 3 interventions - of which HOE901-U300 (Insulin Glargine 300 U/ml) is the first listed.
NCT02688933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02688933 about?
NCT02688933 is a clinical study titled "A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus". Primary Objective: To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus. Secondary Objective: To demonstrate that treatment with HOE901...
What is the current status of trial NCT02688933?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 638 participants. The study started on 2016-05-05. Estimated completion is 2017-06-19.
What interventions are being tested in trial NCT02688933?
The interventions under investigation include: HOE901-U300 (Insulin Glargine 300 U/ml) (DRUG), Lantus (Insulin Glargine 100 U/ml) (DRUG), Mandated back ground therapy (DRUG).
Who is sponsoring clinical trial NCT02688933?
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 NCT02688933's enrollment target sits among peer trials
638 127th of 2000 higher than 1,874 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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