At a glance
ClinicalIndex Comparison Record- ✓Age ≥50 years
- ✓IFG (fasting glucose 110-125 mg/dL) or IGT (2-hour glucose 140-199 mg/dL) or early type 2 diabetes with fasting glucose ≥126 or 2-hour glucose ≥200 mg/dL
- ✓For early type 2 diabetes: either no pharmacologic treatment for ≥10 weeks prior to screening, OR on a single oral antidiabetic drug (sulfonylurea, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, or meglitinide) at stable dose for ≥10 weeks
- ✓At least one cardiovascular risk factor: prior MI (≥5 days prior), prior stroke (≥5 days prior), prior revascularization, angina with ischemic changes, microalbuminuria/albuminuria, left ventricular hypertrophy, significant arterial stenosis (≥50%), or ankle-brachial index <0.9
- ✕Type 1 diabetes
- ✕Currently requiring insulin or with uncontrolled/symptomatic hyperglycemia likely to require insulin or new antidiabetic agent within 2 weeks of randomization
- ✕Positive anti-GAD antibody in the past
- ✕CABG within 4 years prior to screening (unless CV event has occurred since prior CABG)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating insulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), and 2 other interventions for Diabetes Mellitus, Non-Insulin-Dependent. Completed, enrolled 12,537 participants across 40 sites in 40 countries.
Detailed 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.
Study Details
Timeline
Interventions
Cartridges for use in a pen device, each containing 3 mL of insulin glargine 100 U/mL solution for injection
Gelatin capsules (containing icosapent ethyl esters 465 mg and doconexent ethyl esters 375 mg) for oral administration
Matching placebo gelatin capsules (containing olive oil) for oral administration