Lilly insulin tops Sanofi's Lantus in trials; liver issue persists

Last Updated: 2015-06-08

By Bill Berkrot

(Reuters) - A long-acting insulin being developed by Eli Lilly and Co demonstrated greater blood sugar reduction than Sanofi SA's top-selling Lantus in patients with type 2 diabetes, according to data from three Phase III trials presented on Saturday.

More patients in the studies who received Lilly's basal insulin peglispro (BIL) also got their A1c level down to the American Diabetes Association (ADA) recommended target of less than 7%, researchers reported.

However, side effects could be a stumbling block to approval of Lilly's drug. Patients taking BIL had a significant increase in alanine aminotransferase (ALT), although no liver injuries were reported, and liver fat content was higher after BIL treatment for some patients. BIL also raised levels of triglycerides.

The company has delayed applying for approvals until after 2016 as it studies the liver issues.

Trials involving more than 2,800 patients compared BIL with Lantus, also known as insulin glargine, in those not previously treated with insulin, in those using basal insulin with mealtime insulin, and those already taking basal insulin.

Rates of severe hypoglycemia were similar for BIL and Lantus. Lilly's drug caused less nocturnal hypoglycemia.

"BIL is the first and only basal insulin to consistently demonstrate superior glycemic benefits along with a reduction in nocturnal hypoglycemia and a weight advantage compared to insulin glargine in Phase III clinical studies," Dr. Melanie Davies, the studies lead investigator who presented the data at the ADA meeting in Boston, said in a statement.

In the first study, BIL patients saw average A1c reductions of 1.6% after one year versus 1.3% for Lantus. The second study saw blood sugar reductions of 1.7% versus 1.5% for Lantus after 26 weeks. In the third, after 26 weeks, average A1c decreased 0.82% versus 0.29% with Lantus.

The percentages of patients whose A1c reached ADA target levels were 58%, 63% and 73%, respectively, with BIL. That compared with 43%, 53% and 52% for Lantus.

BIL is also being tested for type 1 diabetes.