October 4, 2018
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 HbA1c 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 programme in adults with type 1 diabetes. The EASE programme results were published online in Diabetes Care ahead of print and presented at the 54th EASD Annual Congress in Berlin on 4th October, 2018.1
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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 adjunct to insulin over 52 weeks, while the EASE-3 study evaluated doses of 2.5, 10 and 25 mg of empagliflozin as adjunct to insulin over 26 weeks. In EASE-2, placebo-corrected mean change from baseline in HbA1c at week 26 was -0.54% and -0.53% for empagliflozin 10 and 25 mg, respectively. In EASE-3 placebo-corrected mean change from baseline in HbA1c at week 26 was -0.28%, -0.45% and -0.52% for empagliflozin 2.5 and 10 and 25 mg, respectively. In addition to reduction in HbA1c, empagliflozin treatment was effective on secondary endpoints, showing reductions in weight, decreases in blood pressure, and decreases in total daily insulin dose.1
In addition, data from continuous glucose monitoring in the EASE programme indicates that patients treated with empagliflozin had improved glycaemic variability and spent more time in range, although the data for the 2.5 mg dose are limited.1
There was no increase in the risk of investigator-reported hypoglycaemic events, including severe hypoglycaemia, with empagliflozin treatment, which was a key secondary endpoint in the trials. Additionally, a reduction in patient-reported hypoglycaemic 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 programme was generally consistent with the previously reported safety profile of empagliflozin in adults with type 2 diabetes.1
“The goal of the EASE programme 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 DKA for people with type 1 diabetes, the 2.5 mg empagliflozin dose warrants consideration, as it balances glycaemic 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 programme demonstrated that empagliflozin helps patients with type 1 diabetes to remain within their target glucose range better than insulin alone,” said Dr. Jyothis George, Global Head of Clinical Development, Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “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.”
Jeff Emmick, M.D., Ph.D., Vice President of Product Development for Lilly Diabetes, added: “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.”
An estimated 425 million adults worldwide have type 1 and type 2 diabetes.2 Type 2 diabetes is the most common form, accounting for around 90 percent of all cases.2 Diabetes is a chronic disease that occurs when the body does not properly produce, or use, the hormone insulin.
About the EASE Phase III programme
The EASE Phase III programme includes two multinational, double-blinded, placebo-controlled Phase III clinical trials to investigate the efficacy, safety and tolerability of once-daily Empagliflozin as Adjunctive to inSulin thErapy in adults with type 1 diabetes (EASE), an indication for which empagliflozin is currently not approved.
Empagliflozin is an SGLT2 inhibitor, which provides blood sugar control with additional benefits of weight loss and lowering blood pressure* in adults with type 2 diabetes. Empagliflozin is the first and only oral diabetes medicine approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. The benefit-risk profile of empagliflozin has been well-established in its approved indications. Type 1 diabetes is currently not an approved indication of empagliflozin.
* Jardiance® is not indicated for weight loss or blood pressure reduction.
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