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NCT01658579 · ClinicalTrials.gov registry record · Phase 2
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT01658579 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 59 participants.
The verdict
NCT01658579, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
Primary Objective: * To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives: * To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening * To compare the incidence and frequency of hypoglycemic episodes * To assess the safety and tolerability of the new formulation of insulin glargine
Interventions
- DRUG HOE901-U300 (new formulation of insulin glargine)
- DRUG Lantus (insulin glargine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01658579
The ClinicalTrials.gov registry entry for NCT01658579 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 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 2 interventions - of which HOE901-U300 (new formulation of insulin glargine) is the first listed.
NCT01658579 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01658579 about?
NCT01658579 is a clinical study titled "Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin". Primary Objective: * To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives: * To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening...
What is the current status of trial NCT01658579?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2012-08. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01658579?
The interventions under investigation include: HOE901-U300 (new formulation of insulin glargine) (DRUG), Lantus (insulin glargine) (DRUG).
Who is sponsoring clinical trial NCT01658579?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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