June 6, 2015 / 5:45 PM / 5 years ago

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

June 6 (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 blood sugar down to the American Diabetes Association (ADA) recommended target of less than 7 percent using a common measure known as A1c, researchers reported.

However, side effects could be a stumbling block to approval of Lilly’s drug. Patients taking BIL had a significant increase in the liver enzyme ALT, although no liver injuries were reported, and liver fat content was higher after BIL treatment for some patients. BIL also raised levels of the blood fat 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, or dangerously low blood glucose, were similar for BIL and Lantus. Lilly’s drug caused less nocturnal hypoglycemia, a concern as sleeping patients are not aware they may be in danger.

“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.

Less weight gain is beneficial as obesity is a leading cause of type 2 diabetes.

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

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

BIL is also being tested for type 1 diabetes.

An estimated 387 million people worldwide suffer from diabetes, with type 2 accounting for at least 90 percent. If not properly treated, diabetes can cause a wide variety of serious health problems. (Reporting by Bill Berkrot. Editing by Andre Grenon)

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