ORIGIN Trial (Background, Results)

Abstract

ORIGIN — the longest and most extensive study on Lantus® use in patients with cardiovascular risk with diabetes mellitus (DM) type 2 in the early stages, as well as prediabetes, in which insulin therapy is not indicated now. ORIGIN trial was initiated to investigate the efficacy of therapy with insulin glargine compared with standard therapy in terms of effects on cardiovascular events. The main findings of ORIGIN trial for over 6-year period: — Achievement of target glycemic level doesn’t reduce cardiovascular risks. — Lantus® does not cause the risk of cancer. — Early administration of Lantus® once daily leads to a stable target glycemic control. — In most of patients (58 %) treated with Lantus® the cases of symptomatic hypoglycemia didn’t occur; incidence of severe hypoglycemia was very low (0.01 episodes per 1 patient-year and 0.003 for standard therapy), the incidence of general hypoglycemia was 0.1 episode per 1 patient-year in the insulin glargine group and 0.027 for standard therapy. — Lantus® prevents the progression of prediabetes to diabetes mellitus type 2 (DM occurred in 25 % of those with prediabetes who received insulin glargine, vs. 31 % in the standard therapy, i.e., the risk for DM development was 28 % lower).