Eli Lilly and Company reported that its investigational diabetes treatment basal insulin peglispro (BIL) was more effective than Sanofi's Lantus (insulin glargine) at reducing hemoglobin A1c (HbA1c) in three Phase III clinical trials in patients with type 2 diabetes. The drug is being studied as a once-daily treatment for both type 1 and type 2 diabetes. The primary efficacy endpoint of the trials was to show that the drug was as effective as insulin glargineat reducing hemoglobin A1c (HbA1c).
The clinical trials evaluated three specific populations of patients with type 2 diabetes: those who were not previously taking insulin (IMAGINE-2); those taking basal insulin with mealtime insulin (IMAGINE-4); and those currently taking a basal insulin (IMAGINE-5).
The clinical studies also evaluated the secondary endpoints of nocturnal hypoglycemia rates and changes in weight. In all three trials, patients taking BIL experienced statistically significant lower rates of nocturnal hypoglycemia than those taking Lantus. In addition, patients taking BIL had comparable to statistically significant less weight gain, Lilly reported.
Top-line results for the Phase III clinical trials of patients with type 1 diabetes are planned for release by the end of Q3 this year at the time when both Phase III clinical trials are complete.
Lilly plans to file for approval in the United States and Europe by the end of the first quarter in 2015, said Enrique Conterno, president of Lilly Diabetes.