Insulin Glargine

ORIGIN (Outcome Reduction with Initial Glargine Intervention), a long-term international clinical trial conducted on 12,537 people in 40 countries, over a period of six years, assessed the effect of therapy with basal insulin (supplied as insulin glargine) on cardiovascular and other health outcomes in high risk people with dysglycemia (i.e. either pre-diabetes or type 2 diabetes).

Trial Features

• Primary outcome status was known for 99.3% participants at the end of the study.
• More than 50% of participants allocated to insulin glargine achieved a FPG level below 5.3 mmol/l and 75% of these participants achieved FPG levels < 6.0 mmol/l (108 mg/dl) for most of the trial.
• The median insulin dose for glycemic control increased from 0.31 U/kg by year 1, to 0.40 U/kg by year 6.
• At 5 years, more than 85% of participants allocated to insulin glargine were taking the drug and by the end of the study 80% were taking any insulin.

Trial Results

• There was no difference in the incidence of cardiovascular events, cancers or other health outcomes in the insulin glargine and standard care groups (2.94 and 2.85 per 100 person-years; P= 0.63).
• The development of new diabetes in people without diabetes at baseline was reduced by 28%.
• The risk of severe hypoglycemia was 0.7% higher in the insulin glargine group (1% versus 0.3% per year).
• Participants allocated to insulin glargine gained a mean of 1.6 kg during more than 6 years of follow-up compared to 0.5 kg weight loss with standard care.

Significance

• When a glucose lowering drug is needed, basal insulin glargine is now the best studied one available
• Basal insulin glargine slows progression of dysglycemia
• No new adverse health effects of basal insulin were noted, despite more hypoglycemia, with careful collection & adjudication of serious health outcomes
• Although pleiotropic benefits or harms beyond 6-7 years can’t be totally ruled out, exogenous basal insulin’s main effect is to flexibly lower glucose levels

Healthcare Professionals see ORIGIN Trial Overview

Slide set - Insulin Glargine