Eli Lilly and and Boehringer Ingelheim's SGLT2 meets primary efficacy endpoint of phase III program in adults with type 1 diabetes
8 October 2018 -

United States-based Eli Lilly and Company's and Germany-based Boehringer Ingelheim's SGLT2 inhibitor, empagliflozin, has met the primary efficacy endpoint of a phase III program in adults with type 1 diabetes, it was reported on Friday.

The product was evaluated for its efficacy, safety and tolerability as an adjunctive to insulin in comparison to placebo in the late-stage clinical program, named EASE.

The primary efficacy endpoint of the trial is a change from baseline in HbA1c after treatment for 26 weeks with different doses of empagliflozin in comparison to placebo. The EASE-2 study evaluated doses of 10 and 25mg of the SGLT2 inhibitor as adjunct to insulin over 52 weeks, while the EASE-3 study evaluated doses of 2.5, 10 and 25mg of the investigational diabetes drug as adjunct to insulin over 26 weeks.

Apart from reduction in HbA1c, empagliflozin was demonstrated to be effective on secondary endpoints, resulting in weight reductions, lowering of blood pressure, and decreases in total doses of daily insulin. Also, data from continuous glucose monitoring in the EASE program showed that patients subjected to empagliflozin had improved glycaemic variability and spent more time in range.