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NCT01499095 · ClinicalTrials.gov registry record · Phase 3
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 811
- Enrollment target
NCT01499095 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 811 participants.
The verdict
NCT01499095, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 811 participants
- Enrollment target
Study Summary
Primary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia
Interventions
- DRUG Lantus (Insulin glargine)
- DRUG HOE901-U300 (new formulation of insulin glargine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 811 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01499095
The ClinicalTrials.gov registry entry for NCT01499095 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 811 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 Lantus (Insulin glargine) is the first listed.
NCT01499095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01499095 about?
NCT01499095 is a clinical study titled "Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy". Primary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: * To compare the efficacy of ins...
What is the current status of trial NCT01499095?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 811 participants. The study started on 2011-12. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01499095?
The interventions under investigation include: Lantus (Insulin glargine) (DRUG), HOE901-U300 (new formulation of insulin glargine) (DRUG).
Who is sponsoring clinical trial NCT01499095?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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