Phase 3 Trial Update of Lantus for Pre-diabetes, Early Type 2 Diabetes with High Cardiovascular Risk

Sanofi announced new results from the Phase 3 ORIGIN trial evaluating Lantus (insulin glargine) in individuals with pre-diabetes or early type 2 diabetes at high cardiovascular (CV) risk.

ORIGIN (Outcome Reduction with Initial Glargine Intervention) was a six-year landmark cardiovascular (CV) outcomes trial, evaluating Lantus vs. standard care in over 12,500 individuals who were at high CV risk with pre-diabetes (impaired fasting glycemia or impaired glucose tolerance) or early type 2 diabetes mellitus (treated at most with one oral anti-diabetic). The trial used a 2x2 factorial design to determine whether using insulin glargine to target fasting normoglycemia (FPG ≤95mg/dL), and separately omega-3 polyunsaturated fatty acids (PUFA), could reduce cardiovascular morbidity and/or mortality. Participants assigned to standard care were treated on the basis of the investigator's best judgment and local guidelines, including lifestyle measures, dietary modifications, metformin, sulfonylureas and other oral anti-diabetic agents.

Patients treated with Lantus were approximately 3-fold more likely (P<0.001) to achieve and maintain target glycemic levels, defined as HbA1C <6.5% in this analysis, vs. standard care. Data showed that insulin glargine use was an independent predictor of maintaining mean yearly HbA1c <6.5% target over 5 years vs. standard care. Similarly, a lower HbA1c baseline level was also found to predict reaching the same target. 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).

Key results reported earlier this year showed insulin glargine had a neutral effect on CV outcomes and significantly reduced progression from pre-diabetes to diabetes (secondary outcome) by 28% (P=0.006).

Lantus is a long- acting human insulin analog indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

For more information call (800) 446-6267 or visit www.sanofi.us.