Sanofi announced new results from the landmark ORIGIN (Outcome Reduction with Initial Glargine INtervention) trial showing treatment with Lantus (insulin glargine) was approximately three-fold more likely (p<0.001) to achieve and maintain target glycemic levels, defined as HbA1C < 6.5 per cent in this analysis, vs standard care in individuals with pre-diabetes or early type II diabetes at high cardiovascular (CV) risk.
Data presented at the European Association for the Study of Diabetes (EASD) 48th Annual Meeting showed that insulin glargine use was an independent predictor of maintaining mean yearly HbA1c <6.5 per cent target over five years, vs standard care. Similarly, a lower HbA1c baseline level was also found to predict reaching the same target.
ORIGIN was a six-year randomised clinical trial designed to assess the effects of treatment with insulin glargine vs standard care on CV outcomes and involved over 12,500 participants worldwide with pre-diabetes (impaired fasting glycemia or impaired glucose tolerance) or early type II diabetes (treated at most with one oral anti-diabetic) and high CV risk. Key results reported earlier this year at the American Diabetes Association Congress (June 2012) showed insulin glargine had a neutral effect on CV outcomes and significantly reduced progression from pre-diabetes to diabetes (secondary outcome) by 28 per cent (p=0.006).1
“This analysis shows that insulin glargine generally brought glycemic control to HbA1c <6.5 per cent, a commonly sought target, and sustained it over five years. Further study of the ORIGIN data is likely to provide further insights regarding the medical benefits or risks of this approach to treatment,” stated Professor Matthew Riddle MD, Oregon Health and Science University, USA, lead author of this ORIGIN sub-analysis.
These new findings showed that insulin glargine was more effective than standard care at maintaining glycemic control in all subgroups assessed, including age, alcohol consumption, depression, baseline HbA1c, urine albumin:creatinine ratio (ACR), diabetes and particularly in individuals with abdominal obesity (p=0.011) and greater grip strength (p<0.001).
Dr Riccardo Perfetti, Vice President Medical Affairs, Global Diabetes, Sanofi, commented: “Contrary to conventional understanding that diabetes is a progressively worsening disease, these new results from this sub-study of ORIGIN suggest that achieving and maintaining glycemic control early with insulin glargine might positively affect the natural history of the disease.”
Safety outcomes from the new ORIGIN sub-study were not included in the presentation at the EASD 48th Annual Meeting. Hypoglycemic events as observed in the ORIGIN main study were infrequent: In the insulin glargine arm, the rate of severe hypoglycemia was 0.01 episodes per patient-year of exposure versus 0.003 episodes per patient-year for standard care. Rates for overall hypoglycemia with insulin glargine were 16.7 patients with events per 100 patient-years of exposure versus 5.2 patients with events per 100 patient-years for standard care. In addition, weight gain was modest for participants in the insulin glargine arm, at an average of 3.5 pounds over the duration of the study.
EP News Bureau