Eli Lilly and Company (Lilly) and Boehringer Ingelheim said that their SGLT2 inhibitor empagliflozin has met the primary efficacy endpoint of a phase III program in adults with type 1 diabetes.
Empagliflozin was evaluated for its efficacy, safety and tolerability as an adjunctive to insulin in comparison to placebo in the late-stage clinical program, dubbed 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 assessed 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.
Lilly diabetes product development vice president Jeff Emmick said: “The Boehringer Ingelheim-Lilly Diabetes Alliance is committed to helping people improve the management of their diabetes, and the EASE programme is part of our broader efforts to explore treatment options that address unmet needs.”
Boehringer Ingelheim said that it has initiated regulatory discussions for empagliflozin as adjunct to insulin for type 1 diabetes in adults, on the basis of the totality of the EASE data.
Boehringer Ingelheim Clinical Development, Therapeutic Area CardioMetabolism global head Jyothis George said: “The EASE programme demonstrated that empagliflozin helps patients with type 1 diabetes to remain within their target glucose range better than insulin alone.
“There are currently no oral treatment options available for people with type 1 diabetes and these results show that empagliflozin could benefit these individuals. We look forward to working with regulatory authorities to explore whether this potential treatment can be made available to adults with type 1 diabetes.”