Late Stage Trials Prove Lilly Diabetes Drug Set To Battle Sanofi's Lantus

Eli Lilly has announced that its type 2 diabetes drug served as an effective treatment for lowering patients’ blood sugar levels. The Eli Lilly drug, basal insulin peglispro, was in three late-stage trials. The three trials tested three types of patients: those who had not previously taken insulin, those who were taking insulin at meals, and those who were taking another type of basal insulin. Following the trials, the company has found that the drug met its primary endpoint of non-inferior reduction in hemoglobin A1c compared to insulin glargine.

According to Reuters, Eli Lilly initially began the research in hopes of determining that the company’s drug is as effective as Sanofi’s FDA approved Lantus, but it ultimately proved to reduce blood sugar levels more effectively than the Sanofi drug. Lantus is currently the most prescribed insulin drug product in the world, garnering $2 billion in worldwide sales. The Sanofi drug is scheduled to lose patent protection in February of 2015. Eli Lilly expects to file for approval for its type 2 diabetes drug with European and U.S. regulators by the end of 2015’s first quarter. Analysts have also projected sales for the Eli Lilly drug to reach $242 million by 2018.

Enrique Conterno, the president of Lilly Diabetes, says, “These results are promising.  Basal insulin peglispro is the first basal insulin to demonstrate consistently superior HbA1c reduction versus insulin glargine in Phase III clinical trials.If approved, BIL could offer a differentiated profile and provide an important new treatment option for patients with diabetes. We are on track to make regulatory filings by Q1 next year.”

David Kendall, MD and distinguished medical fellow at Lilly Diabetes, also released a statement, saying "In patients with type 2 diabetes taking insulin glargine, nocturnal hypoglycemia and weight gain may be barriers to improving glycemic control. The fact that patients treated with BIL had lower rates of nocturnal hypoglycemia and comparable to less weight gain while achieving superior improvements in glycemic control is noteworthy.”