The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

Phase 3 Completed 12537 enrolled Sanofi Population Health Research Institute · collab

RandomizedFactorialOpen-labelTreatment

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.

Timeline

Start: 2003-08
Primary completion: 2011-12
Completion: 2011-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Insulin Glargine vs Standard Care; p = 0.6273; Cox Proportional Hazard 1.022 (95% CI 0.937 to 1.114); Log Rank; NCT00069784 ↗

registry analysis (superiority or other test); Insulin Glargine vs Standard Care; p = 0.2692; Cox Proportional Hazard 1.038 (95% CI 0.972 to 1.109); Log Rank; NCT00069784 ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omega-3 fatty acids	Unknown	1 g	Oral
Subject	insulin glargine	Protein / enzyme biologic	—	Subcutaneous