The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

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.

Conditions

• Diabetes Mellitus, Non-Insulin-Dependent

Interventions

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

Sponsors & Collaborators

• Population Health Research Institute

  collaborator OTHER

• Sanofi

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

• Hertzel Gerstein, M.D. · McMaster University and Hamilton Health Sciences

• Salim Yusuf, M.D. · McMaster University and Hamilton Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-08-31

Primary Completion

2011-12-31

Completion

2011-12-31

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

Study Locations