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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 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 638 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02688933
The ClinicalTrials.gov registry entry for NCT02688933 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 638 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which HOE901-U300 (Insulin Glargine 300 U/ml) is the first listed.
NCT02688933 reports 0 study locations.
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.
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