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NCT00069784 · ClinicalTrials.gov registry record · Phase 3
The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 12,537
- Enrollment target
NCT00069784 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 12,537 participants.
The verdict
NCT00069784, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12,537 participants
- Enrollment target
Study Summary
The primary objectives of the ORIGIN study were: * To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes; * To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes. The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce: * total mortality (all causes); * the risk of diabetic microvascular outcomes; * the rate of progression of IGT or IFG to type 2 diabetes.
Interventions
- DRUG placebo
- DRUG insulin glargine (HOE901)
- DRUG omega-3 polyunsaturated fatty acids (PUFA)
- DEVICE reusable pen device for insulin injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,537 participants |
| Start Date | 2003-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00069784
The ClinicalTrials.gov registry entry for NCT00069784 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 12,537 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 4 interventions - of which placebo is the first listed.
NCT00069784 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00069784 about?
NCT00069784 is a clinical study titled "The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)". The primary objectives of the ORIGIN study were: * To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type...
What is the current status of trial NCT00069784?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12,537 participants. The study started on 2003-08. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00069784?
The interventions under investigation include: placebo (DRUG), insulin glargine (HOE901) (DRUG), omega-3 polyunsaturated fatty acids (PUFA) (DRUG), reusable pen device for insulin injection (DEVICE).
Who is sponsoring clinical trial NCT00069784?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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