ORIGIN stands for "Outcome Reduction with Initial Glargine Intervention"

What is the ORIGIN Study?

ORIGIN is an international study looking at people who are at high risk for cardiovascular disease and who also have Type 2 Diabetes or a pre-diabetic condition such as Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT).  In this study attempts will be made to reduce the risk of heart attacks, strokes, and other cardiovascular events by using insulin glargine to normalize blood sugar levels.  The ORIGIN study is also investigating whether or not omega-3 polyunsaturated fatty acids (n-3 PUFA) can also reduce risk.  It is anticipated that 10,000 participants from all over the world will be enrolled in the ORIGIN study.

What is Insulin glargine?

Insulin glargine (also called Lantus) is a new basal insulin analogue whose slow and steady absorption allows for better blood sugar control with less hypoglycemia.  Learn more about insulin analogues.

What are omega-3 polyunsaturated fatty acids?

Omega-3 polyunsaturated fatty acids are the fats present in fish oil.  There has been epidemiological evidence suggesting that their consumption may reduce the risk of cardiovascular disease, but this has yet to be confirmed in a large randomized clinical trial such as ORIGIN.

What are the benefits of joining ORIGIN?
bulletFree advice about healthy lifestyle choices: consultation with a registered dietitian, exercise recommendations
bulletFree glucose meter, supplies (lancets and strips), and training
bulletIndividualized patient education about control of diabetes
bulletCoverage of diabetes medications (insulin, some pills)
bulletCoverage of omega-3 fatty acid medication
bulletCoverage of all parking costs

Am I eligible?

Men and women over the age of 50 are eligible for ORIGIN.  You must also be willing to do finger-stick blood sugar checks and take insulin to control blood sugars.  More complex eligibility criteria is listed below, but it is best to go through it with either your family doctor or you can also inquire about your eligibility by phoning the number listed below.

I am interested in volunteering or finding out more...

Hamilton General Hospital ORIGIN Clinic Phone: 905-521-2100 x44612



ORIGIN Complete Eligibility Criteria
bulletMen and women age > 50
bulletIFG (FBS 6.1 and < 7.0 mM)
bulletIGT (75g OGTT, 2hPG ≥ 7.8 and < 11.1 mM)
bulletEarly Type 2 DM (prior diagnosis, FPG ≥ 7.0 mM or 2hPG ≥ 11.1 mM) and...
bulletOn no Treatment for at least 10 wks and HbA1c < 9 %
bulletOne OHA at stable (< half-max) dose for 10 wks and HbA1c < 8.5 %
bulletOne OHA at stable (≥ half-max) dose for 10 wks and HbA1c > 8.0 %
bulletAt least one of the following cardiovascular risk factors:
bulletprior Myocardial Infarction (≥ 5 days prior to randomization)
bulletprior stroke (≥ 5 days prior to randomization)
bulletprior coronary, carotid, or peripheral arterial revascularization (Note: cannot have had a CABG within 4 years unless there has been a documented MI or definite angina since the CABG)
bulletstable angina with Gxt ST depression ≥ 2 mm or positive cardiac imaging study
bulletunstable angina with ST depression ≥ 1 mm or elevated troponin I above normal range but below cutoff for definite MI
bulletMicroalbuminuria (albumin/creatinine ratio > 30 ug/mg first AM urine)
bulletLVH by EKG or Echo
bullet≥ 50 % stenosis on angiogram of coronary, carotid, or leg artery
bulletankle/brachial index < 0.9
bulletProvision of signed and dated informed consent
bulletAbility and willingness to complete study diaries and questionnaires
bulletDemonstrated ability to use glucose monitor and self-inject insulin prior to randomization
bulletNegative pregnancy test for all child-bearing women
bulletWillingness to discontinue prior omega-3 PUFA supplements

ORIGIN Exclusion Criteria
bulletType 1 Diabetes mellitus
bulletRequiring insulin therapy
bulletGAD antibody positive
bulletHbA1c > 9 %
bulletUnwilling to inject insulin or self-test blood glucose
bulletNon-adherence with the run-in requirement to inject placebo insulin and test capillary blood glucose for at least 4 days prior to randomization
bulletCABG in past 4 years unless documented MI or definite angina since the CABG
bulletSerum creatinine > 175 uM
bulletActive liver disease, ALT or AST > 2.5x ULN at screening
bulletSystemic corticosteroids, niacin
bulletCHF NYHA III or IV
bulletExpected survival < 3 years from noncardiovascular disease
bulletCancer other than nonmelanoma skin cancer within last 3 years
bulletUnwilling or unable to discontinue thiazolidinedione
bulletSimultaneous participation in another clinical trial of active treatment
bulletHistory of hypersensitivity to study drug(s)
bulletPrior heart transplant or awaiting transplant
bulletUnwilling to permit study site to contact primary care physician