ADA Boston

Lilly Insulin Tops Sanofi's Lantus in T2DM Trials

(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 downA  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.

Novo Nordisk Type 2 Diabetes Combo Drug Tops Sanofi's Lantus

(Reuters) - Novo Nordisk's IDegLira combination drug for type 2 diabetes led to significant reductions in blood sugar, weight and rate of hypoglycemia compared with Sanofi's top-selling Lantus insulin product, according to data from a late-stage trial presented at a medical meeting on Sunday.

The Novo drug, given by once-daily injection, combines its experimental long-acting insulin degludec with liraglutide, a type 2 diabetes treatment sold under the brand name Victoza that was recently approved under another name for weight loss.

IDegLira could give doctors an attractive alternative to raising insulin doses in patients who require additional treatment to get blood sugar levels to the target recommended by the American Diabetes Association (ADA).

"The results demonstrated that IDegLira treatment could positively impact patients who are not in control on their current basal insulin therapy," Professor John Buse, the study's lead investigator, said in a statement.

The combination treatment was recently approved in Europe as Xultophy, but the Danish drugmaker cannot apply to sell it in the United States until the insulin degludec component is independently approved. That drug is in the midst of a large study designed to clear it of heart safety concerns.

In the 26-week, 557-patient phase III study presented at the ADA meeting in Boston, those who received IDegLira on average saw A1c levels, a common measure of blood sugar over time, reduced by 1.8% versus a drop of 1.1% for those who increased their dose of Lantus, also known as insulin glargine.

Seventy-two percent of IDegLira patients achieved the ADA target A1c level of below 7% compared with 47% in the Lantus group. There was a 57% lower rate of hypoglycemia, or potentially dangerously low blood sugar, observed with the Novo medicine.

In addition, the liraglutide component of Novo's combination appears to more than offset the weight gain commonly seen with insulin. IDegLira patients lost an average of 3 pounds (1.4 kilograms) versus a weight gain of 4 pounds (1.8kg) in the Lantus group.

Weight loss is a particularly attractive benefit as obesity is a leading cause of type 2 diabetes.

Nearly 400 million people worldwide have diabetes, with type 2 accounting for more than 90%. Without proper treatment or lifestyle changes, those numbers are expected to grow substantially in coming years.



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