(Glucose Reduction and Atherosclerosis Continuing Evaluation)
Participants with a history of cardiovascular (CV) disease and with impaired fasting glucose, glucose intolerance or early type 2 diabetes mellitus are at high risk for CV events and for rapid progression of atherosclerotic vascular disease.
Atherosclerosis progression was evaluated by quantitative B-mode carotid ultrasound in a subset of participants. The primary outcome is the annualized progression slope of the mean maximum intima-media (IMT) thickness across 12 predefined carotid arterial segments.
(Echocardiographic Study of Left Ventricular Mass and Function in Patients with Dysglycemia and Cardiovascular Disease)
Patients with diabetes may have increased left ventricular mass and abnormalities in left ventricular (LV) diastolic and systolic function, often referred to as diabetic cardiomyopathy. These abnormalities may extend also to patients with “mild” pre-diabetic hyperglycemic disorders.
Echocardiography (M-mode) will be used to evaluate LV mass, LV diastolic and LV systolic function in a subset of ORIGIN participants
Diabetes and dysglycemia are risk factors for an accelerated rate of cognitive decline. Evidence from recent years supports the hypothesis that normalizing glucose levels with insulin may prevent or delay this process. Alternatively an increased risk of hypoglycemia due to glucose lowering may accelerate the pace of cognitive decline.
Two standardized cognitive instruments, the Mini Mental State Examination (MMSE) and Digit Symbol Substitution Test (DSS) were administered to ORIGIN participants at four time periods throughout the study, including the baseline and final visit.
Patients with diabetes are at increased risk for erectile dysfunction (ED). This risk gets progressively worse with higher levels of dysglycemia. Furthermore, therapies for ED, such as sildenafil, have reduced efficacy in patients with diabetes. To date, no randomized trials have looked at whether interventions that improve glycemic control can reduce the incidence or frequency of ED. This study provides a unique opportunity to investigate this question as the study population has 3 independent risk factors for ED: dysglycemia, high cardiovascular risk, and age > 50.
The validated International Index of Erectile Function (IIEF) was administered to male ORIGIN participants at four time points throughout the study (baseline, 2 years, 2010 and final visits).
Economic analyses are aimed at helping administrators and doctors to make the best use of scarce health. The ORIGIN trial is a large study with potentially significant implications to clinical practice around the world. It is critical to understand the cost implications that this trial may have on a healthcare system. To that end, this substudy proposes to use economic analyses to evaluate glucose management using insulin glargine compared with standard care.
To evaluate the cost consequence analysis of using insulin glargine vs. standard care in the ORIGIN trial by comparing the total average cost implications of to the two arms vs the impact on cardiovascular mortality and morbidity within the trial period of ORIGIN.
In 2009, five reports addressing a possible relationship between insulin glargine and cancer were released. Each study came to different conclusions: 1 showed no relationship between glargine insulin and cancer; 2 suggested a relationship with breast cancer when just glargine insulin was used, but not if it was combined with other drugs; and 1 suggested that there was a relationship at high but not low doses of glargine. These different results did not come from randomized trials such as ORIGIN. Instead they were derived from short analyses of information available to health authorities over a three year period. A fifth report from a longer five year randomized trial did not show any relationship between glargine and cancer. Cancer events have been collected and adjudicated throughout the ORIGIN study. The results of the analysis will help determine whether glargine insulin or omega 3 fatty acids (or both) prevent or promote cancer.
© 2012 PHRI |