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?
 | Free advice about healthy lifestyle choices:
consultation with a registered dietitian, exercise recommendations
| Free glucose meter, supplies (lancets and strips), and training
| Individualized patient education about control of
diabetes
| Coverage of diabetes medications (insulin, some pills) | Coverage of omega-3 fatty acid medication | Coverage 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
| Men and women age > 50
| IFG (FBS ≥ 6.1
and < 7.0 mM) | IGT (75g OGTT, 2hPG ≥ 7.8 and < 11.1
mM) | Early Type 2 DM (prior diagnosis, FPG ≥ 7.0 mM or 2hPG ≥ 11.1
mM) and...
|
At least one of the following cardiovascular risk factors:
|
Provision of signed and dated informed consent | Ability and willingness to complete study diaries and questionnaires | Demonstrated ability to use glucose monitor and self-inject insulin prior
to randomization | Negative pregnancy test for all child-bearing women | Willingness to discontinue prior omega-3 PUFA supplements | |
ORIGIN Exclusion Criteria
| Type 1 Diabetes mellitus
| Requiring insulin therapy | GAD antibody positive | HbA1c > 9 % | Unwilling to inject insulin or self-test blood
glucose | Non-adherence with the run-in requirement to inject
placebo insulin and test capillary blood glucose for at least 4 days prior
to randomization | CABG in past 4 years unless documented MI or
definite angina since the CABG | Serum creatinine > 175 uM | Active liver disease, ALT or AST > 2.5x ULN at
screening | Systemic corticosteroids, niacin | CHF NYHA III or IV | Expected survival < 3 years from
noncardiovascular disease | Cancer other than nonmelanoma skin cancer within
last 3 years | Unwilling or unable to discontinue thiazolidinedione | Simultaneous participation in another clinical trial
of active treatment | History of hypersensitivity to study drug(s) | Prior heart transplant or awaiting transplant | Unwilling to permit study site to contact primary
care physician | |