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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by (Responsible Party): | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00069784 |
Purpose
To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either IFG, 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 ORIGIN study is being conducted by the Population Health Research Institute in Hamilton, Ontario (Canada) and an independent Steering Committee. The Principal Investigators are Dr. Hertzel Gerstein and Dr. Salim Yusuf, both at Hamilton Health Sciences and the McMaster University Faculty of Health Sciences.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Non-Insulin-Dependent |
Drug: insulin glargine (HOE901) Drug: omega-3 fatty acids Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| 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), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention) |
| Estimated Enrollment: | 12500 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: insulin glargine (HOE901)
injection
Other Name: Lantus
Drug: omega-3 fatty acids
oral administration
Other Name: Omacor (ethyl esters of omega-3 polyunsaturated fatty acids)
|
| Experimental: 2 |
Drug: insulin glargine (HOE901)
injection
Other Name: Lantus
Drug: placebo
oral administration
|
| Experimental: 3 |
Drug: omega-3 fatty acids
oral administration
Other Name: Omacor (ethyl esters of omega-3 polyunsaturated fatty acids)
|
| Placebo Comparator: 4 |
Drug: placebo
oral administration
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Glucose tolerance status for all candidates who are not known to have diabetes will be determined on the basis of a 75 gram oral glucose tolerance test (OGTT) that will be performed fasting (i.e. no consumption of food or beverage other than water for at least 8 hours). Two plasma glucose values will be drawn during this OGTT - a fasting value and a value drawn two hours after the 75g oral glucose load is administered (PPG).
Participants must have one of the following:
Participants must be at risk for cardiovascular disease, based on satisfying one or more of the following criteria:
Exclusion criteria
Contacts and Locations
Show 40 Study Locations| Study Director: | Clinical Sciences & Operations | Sanofi-Aventis |
More Information
| Responsible Party: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00069784 History of Changes |
| Other Study ID Numbers: | LTS6035, HOE901B/4032 |
| Study First Received: | October 1, 2003 |
| Last Updated: | December 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Impaired Fasting Glucose (IFG) Impaired Glucose Tolerance (IGT) |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperglycemia |
Glargine Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |