ADA: Studies point to safety, efficacy profile for new insulin glargine product

LY2963016 insulin glargine has a similar safety and efficacy profile to currently marketed insulin glargine, according to data recently presented the American Diabetes Association (ADA) Scientific Sessions in San Francisco.

The Boehringer Ingelheim  and Eli Lilly and Company Diabetes alliance presented two phase 3 studies, ELEMENT-1 and ELEMENT-2, in patients with type 1 and type 2 diabetes, respectively. These studies evaluated whether glycemic control achieved with LY2963016 insulin glargine was similar to currently marketed insulin glargine.

ELEMENT-1 was a 52-week phase 3, randomized, open-label study of 535 patients with type 1 diabetes. The primary objective was to evaluate whether LY2963016 insulin glargine was non-inferior to currently marketed insulin glargine in reducing average blood sugar levels (HbA_1c]) from baseline at 24 weeks. Patients in the study were also treated with mealtime insulin. Anti-insulin glargine antibodies were also measured to determine the immunogenicity profile of LY2963016 insulin glargine.

ELEMENT-2 was a 24-week phase 3, randomized, double-blind study of 756 patients with type 2 diabetes. The primary objective was to evaluate whether LY2963016 insulin glargine was non-inferior to currently marketed insulin glargine in reducing average blood sugar levels (HbA_1c) from baseline at 24 weeks in patients inadequately controlled on 2 or more oral diabetes medicines. Anti-insulin glargine antibodies were also measured to determine the immunogenicity profile of LY2963016 insulin glargine.

“Results showed that both LY2963016 insulin glargine and currently marketed insulin glargine led to significant decreases in average blood glucose levels [HbA_1c],” said Gwen Krivi, PhD, vice president, Lilly Diabetes Development.

LY2963016 insulin glargine demonstrated non-inferiority compared to marketed insulin glargine, and marketed insulin glargine demonstrated non-inferiority to LY2963016 insulin glargine. Results also showed a similar immunogenicity profile of LY2963016 insulin glargine to marketed insulin glargine.

“We are confident that, if approved, the alliance’s new insulin glargine product will offer patients with diabetes a basal insulin alternative to currently marketed insulin glargine,” said Krivi.

Lilly and Boehringer Ingelheim sponsored the studies.