Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Sanofi.
NCT00069784 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 12,537 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1526% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with a first occurrence of one of the above events. The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants. Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a
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 |
What the finished NCT00069784 record still lists
NCT00069784 is an interventional study that assigns participants to a tested intervention. Its 12,537 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1526% higher).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT00069784 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00069784's enrollment target sits among peer trials
12,537 20th of 2000 higher than 1,981 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04888832 · 12,500 participants · NA
The Effect of Work Requirements in SNAP in Virginia
- NCT05452941 · 12,500 participants
A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
- NCT07069556 · 12,500 participants
ColoSense Post-Approval Study
- NCT07037433 · 12,800 participants · Phase 3
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia