Clinical trial
The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
NCT00069784 · Sanofi, Industry · Completed
Key facts
| NCT number | NCT00069784 |
|---|---|
| Title | The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention) |
| Official title | A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG)… |
| Acronym | ORIGIN |
| Lead sponsor | Sanofi, Industry |
| Collaborators | Population Health Research Institute |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Diabetes Mellitus, Non-Insulin-Dependent |
| Intervention type | Device, Drug |
| Interventions | insulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), placebo, reusable pen device for insulin injection |
| Enrollment | 12,537 |
| Start date | Aug 1, 2003 |
| Primary completion | Dec 1, 2011 |
| Completion | Dec 1, 2011 |
| First posted | Oct 6, 2003 |
| Last update posted | Jan 31, 2013 |
| Countries | Argentina, Australia, Austria, Belarus, Bermuda, Brazil, Canada, Chile, China, Colombia, Croatia, Denmark and 28 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: