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Boehringer Ingelheim releases results from testing for adjunct to insulin in type 1 diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, Oct. 4, 2018 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today that empagliflozin met the primary efficacy endpoint, defined as a change from baseline in A1C versus placebo after 26 weeks of treatment, for all doses investigated (2.5, 10 and 25 mg) in the Empagliflozin as Adjunctive to inSulin thErapy (EASE) Phase III program in adults with type 1 diabetes. The EASE program results were published online in Diabetes Care ahead of print and presented at the 54th EASD Annual Congress in Berlin today. Empagliflozin is currently not approved for use in type 1 diabetes.

The EASE-2 study evaluated doses of 10 and 25 mg of empagliflozin as an adjunct to insulin over 52 weeks, while the EASE-3 study evaluated doses of 2.5, 10, and 25 mg of empagliflozin as an adjunct to insulin over 26 weeks. In EASE-2, placebo-corrected mean change from baseline in A1C at week 26 was -0.54 percent and -0.53 percent for empagliflozin 10 and 25 mg, respectively. In EASE-3, placebo-corrected mean change from baseline in A1C at week 26 was -0.28 percent, -0.45 percent and -0.52 percent for empagliflozin 2.5 mg, 10 mg and 25 mg, respectively. In addition to reduction in A1C, empagliflozin treatment was effective on secondary endpoints, showing reductions in weight, decreases in blood pressure, and decreases in total daily insulin dose.

In addition, data from continuous glucose monitoring in the EASE program indicates that patients treated with empagliflozin had improved glycemic variability and spent more time in range, although the data for the 2.5 mg dose are limited.

There was no increase in the risk of investigator-reported hypoglycemic events, including severe hypoglycemia, with empagliflozin treatment, which was a key secondary endpoint in the trials. Additionally, a reduction in patient-reported hypoglycemic events was observed. The number of adjudicated diabetic ketoacidosis (DKA) events was comparable between empagliflozin 2.5 mg and placebo, and higher than placebo with empagliflozin 10 and 25 mg. Apart from incidence of DKA, the safety profile observed in the EASE program was generally consistent with the previously reported safety profile of empagliflozin in adults with type 2 diabetes.

"The goal of the EASE program was to determine if treatment with empagliflozin could benefit people with type 1 diabetes as an adjunct to insulin," said Bernard Zinman, M.D., professor in the Department of Medicine, University of Toronto and senior scientist at the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada. "Given the risk of diabetic ketoacidosis for people with type 1 diabetes, the 2.5 mg empagliflozin dose warrants consideration, as it balances glycemic and metabolic improvements that are relevant to patients without increasing their risk of DKA or other serious adverse events."

Based on the totality of the EASE data, Boehringer Ingelheim has initiated regulatory discussions for empagliflozin as adjunct to insulin for adults with type 1 diabetes.

"The EASE trials showed that empagliflozin - an oral treatment - in combination with insulin has potential to help manage blood sugar levels better than insulin alone in adults with type 1 diabetes," said Thomas Seck, M.D., senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Given that less than one third of adults with type 1 diabetes in the U.S. consistently meet target blood sugar levels solely with insulin, we look forward to working with the U.S. Food and Drug Administration to explore whether this potential treatment can be made available to people with type 1 diabetes."

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Todd Schnitt

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