Insulin-producing beta cells of the pancreas release exosomes that are taken up by dendritic cells. Credit: Manu5.

Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company have reported positive top-line results from the EASE trial programme, which includes two Phase III studies designed to examine empagliflozin in combination with insulin therapy in adults with type 1 diabetes.

The multinational, double-blinded, placebo-controlled trials investigated the efficacy, safety and tolerability of once-daily empagliflozin as adjunctive to insulin therapy in the enrolled patients.

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As part of the EASE-2 trial, 10mg and 25mg doses of empagliflozin were evaluated as adjunct to insulin versus placebo for 52 weeks.

A total of 720 patients were enrolled in the trial. Its primary endpoint was change from baseline in A1C after 26 weeks of treatment.

The EASE-3 trial was carried out to compare 10mg and 25mg doses of empagliflozin as adjunct to insulin versus placebo for 26 weeks. A lower dose of empagliflozin (2.5mg) was also investigated in this trial, which enrolled 960 patients.

“Despite recent advances in insulin therapy and patient care, less than one third of adults with type 1 diabetes in the US consistently meet target blood sugar levels.”

Both trials met their primary endpoints, while their safety profile was generally found to be consistent with the previously reported safety profile of empagliflozin.

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Boehringer Ingelheim Pharmaceuticals Primary Care Clinical Development and Medical Affairs vice-president Thomas Seck said: “Despite recent advances in insulin therapy and patient care, less than one third of adults with type 1 diabetes in the US consistently meet target blood sugar levels.

“The EASE trials are part of our comprehensive clinical development programme exploring how empagliflozin may improve patient health outcomes and fill treatment gaps for adults with and without type 2 diabetes, and we look forward to sharing the full results from both trials.”

Empagliflozin is an SGLT2 inhibitor used along with diet and exercise to reduce blood sugar in adults with type 2 diabetes, but has not currently been approved for use in people with type 1 diabetes.