The six-year study, which included more than 12,000 patients, found that the rate of cardiovascular events was 2.94 per 100 person-years in patients with early type 2 diabetes who had cardiovascular risk factors and impaired fasting glucose, impaired glucose tolerance, or use of insulin, compared with 2.85 per 100 person-years in this population on standard therapy, according to MD and his colleagues. Gerstein reported in the American Diabetes Association that the statistical probability of developing cancer was the same in both groups (HR 1.00, 95% confidence interval 0.88 to 1.13, p=0.97). The study was published simultaneously in the New England Journal of Medicine. Gerstein noted that this was the longest and most extensive study comparing the effects of insulin and non-insulin therapy, and that we did not find any risk of tumors in this study at all. The primary endpoints of the study were nonfatal heart attack, nonfatal stroke and cardiovascular death. Secondary endpoint outcomes included primary endpoint outcomes and the need for revascularization and hospitalization for heart failure. The investigators also looked at the occurrence of microvascular outcomes, diabetic events, hyperglycemia, weight, and cancer incidence. The Kaplan-Meier curves for cardiovascular events visually overlapped in both groups. The only real differences were “moderate” weight gain (3 pounds versus 1 pound) and “moderate” hyperglycemia. Now we know its long-term effects on a number of serious and important outcomes.” Other speakers at the presentation also shared the exciting findings. Lars Rydén, MD, from the Karolinska Institute in Stockholm, noted, “As a cardiologist, I am more interested in the morbidity and mortality caused by glucose-lowering drugs, and these results enhance our background knowledge. We are reassured by the fact that we did not observe any adverse conditions caused by the treatment in the long term.” However, we don’t know if these results will lead to expanded use of insulin in patients at risk for diabetes, and Gerstein and other researchers point to these data to give confidence in the safety of insulin. It is particularly important to note that glycosylated hemoglobin levels were similar within the two groups throughout the study. The baseline value of glycated hemoglobin was 6.4 percent in both groups. At year four, the values were 6.1% and 6.4% for the glargine insulin and standard treatment groups, respectively, and 6.2% and 6.5% for the two groups at the end of the trial. The ORIGIN study (Outcome Reduction with an Initial Glargine Intervention) enrolled a total of 12,537 subjects in more than 40 countries. The mean follow-up time was 6.5 years, the mean age of the subjects was 63 years, and 35% were female. At study closure, the investigators were provided with information including primary endpoint outcomes for 99% of subjects. Adherence was good in 90% of patients in the glargine insulin group at year two and 85% at year five. Patients without diabetes assigned to the glargine insulin treatment group were 28% less likely to develop diabetes at the first oral glucose tolerance test compared to patients receiving standard therapy. They then stopped insulin treatment and were about 20 percent less likely to develop diabetes when they underwent a second oral glucose tolerance test about 100 days later. The researchers noted, “Our study showed that patients who had daily basal insulin injections with or without treatment with oral agents could maintain near-normal fasting glucose tests and glycated hemoglobin for nearly 6 years, and that high-risk patients needed to self-check their finger-end glucose levels daily to adjust their insulin dosage.” More than half of the subjects in the insulin group were able to maintain fasting blood glucose test levels at 95 mg/dL, compared with 123 mg/dL for patients taking oral hypoglycemic agents. But the study also had limitations because more than half of the patients in the insulin-treated group were taking metformin – a drug that has cardiovascular which has a protective effect on the heart. And the results of the study only showed the effectiveness of insulin treatment rather than the effectiveness of the treatment in lowering blood glucose.