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NCT01336751 · ClinicalTrials.gov registry record · Phase 3
Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 212
- Enrollment target
NCT01336751 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 212 participants.
The verdict
NCT01336751, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 212 participants
- Enrollment target
Study Summary
Study Primary Objectives: To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin. Study Secondary Objectives : To compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro: * Incidence of hypoglycemia * Change in weight * Change in serum lipid profile * Percentage of subjects achieving A1C levels ≤7%
Interventions
- DRUG Insulin glargine
- DRUG 75% insulin lispro protamine suspension and 25 % insulin lispro injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2001-07 |
| Est. Completion | 2002-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01336751
The ClinicalTrials.gov registry entry for NCT01336751 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 212 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 Insulin glargine is the first listed.
NCT01336751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01336751 about?
NCT01336751 is a clinical study titled "Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment". Study Primary Objectives: To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin. Study Secondary O...
What is the current status of trial NCT01336751?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 212 participants. The study started on 2001-07. Estimated completion is 2002-12.
What interventions are being tested in trial NCT01336751?
The interventions under investigation include: Insulin glargine (DRUG), 75% insulin lispro protamine suspension and 25 % insulin lispro injection (DRUG).
Who is sponsoring clinical trial NCT01336751?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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