NCT00069784

The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,537 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The ORIGIN study was conducted by the Population Health Research Institute in Hamilton, Ontario (Canada), working in conjunction with the sponsor, and an independent Steering Committee. Routine visits were to occur at 2, 4, 8, and 16 weeks following randomization, then every four months for the rest of the study, for all participants The duration of the study was based on the number of events observed (event-driven study) and was originally planned to be 5 years. In 2008-2009 ORIGIN's follow-up was extended by approximately 2 years, because of published literature of completed studies suggesting that a longer period of effective glycemic contrast between treatments might be needed to see an effect on cardiovascular events.

Conditions

• Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Type	Name	Description
DRUG	insulin glargine (HOE901)	Cartridges for use in a pen device, each containing 3 mL of insulin glargine 100 U/mL solution for injection
DRUG	omega-3 polyunsaturated fatty acids (PUFA)	Gelatin capsules (containing icosapent ethyl esters 465 mg and doconexent ethyl esters 375 mg) for oral administration
DRUG	placebo	Matching placebo gelatin capsules (containing olive oil) for oral administration
DEVICE	reusable pen device for insulin injection

Timeline

• Start date: 2003-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2003-10-06
• Last updated: 2013-01-31
• Results posted: 2013-01-25

Locations

40 sites across 40 countries: United States, Argentina, Australia, Austria, Belarus, Bermuda, Brazil, Canada, Chile, China, Colombia, Croatia, Denmark, Estonia, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, Venezuela