BOEHRINGER-INGELHEIM

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that both randomised controlled trials in the EASE phase III programme, investigating the use of empagliflozin in combination with insulin therapy in adults with type 1 diabetes, met their primary endpoint. The primary efficacy endpoint, defined in both trials as placebo-corrected change from baseline in HbA1c after 26 weeks of treatment, was met for all investigated doses of empagliflozin (2.5, 10, and 25 mg).

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Type 1 diabetes currently affects approximately 30 million adults worldwide.¹ It is an autoimmune disease in which the body does not produce sufficient amounts of insulin and therefore requires life-long daily insulin administration to regulate blood sugar. For some people with type 1 diabetes, it may be challenging to manage blood sugar levels with insulin alone. People with type 1 diabetes also face risks of complications such as sight loss, heart disease, kidney disease and amputations.

“Despite recent advances in insulin therapy and patient care, optimal glucose control is difficult to achieve in people with type 1 diabetes. Empagliflozin is an effective and well-established medicine used to treat adults with type 2 diabetes, and our comprehensive clinical trial programme continues to investigate the potential benefits it may offer to a range of adults with diabetes”, said Dr. Jyothis George, Global Head of Clinical Development, Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “Boehringer Ingelheim and Lilly look forward to sharing the results of the EASE phase III programme at EASD.”

The safety profile in both studies was generally consistent with the previously reported safety profile of empagliflozin. The number of adjudicated diabetic ketoacidosis events was comparable between empagliflozin 2.5 mg and placebo and higher than placebo in adults with type 1 diabetes on empagliflozin 10 mg and 25 mg.

The full results from the EASE phase III programme will be presented at the European Association for the Study of Diabetes Annual Meeting on 4^th October, 2018 in Berlin, Germany.

Empagliflozin is currently not approved for use in people with type 1 diabetes. Boehringer Ingelheim and Lilly are discussing next steps and exploring regulatory options.

About Diabetes

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 E mpagliflozin as A djunctive to inS ulin thE rapy in adults with type 1 diabetes (EASE), an indication for which empagliflozin is currently not approved.

• EASE-2 [NCT02414958] evaluated 10 mg and 25 mg doses of empagliflozin as adjunct to insulin versus placebo for 52 weeks.³
  Primary endpoint: Change from baseline in HbA1c after 26 weeks of treatment
  Number of patients: 720
• EASE-3 [NCT02580591] compared 10 mg and 25 mg doses of empagliflozin as adjunct to insulin versus placebo for 26 weeks. Additionally, a lower dose of empagliflozin (2.5 mg) was investigated in this trial⁴
  Number of patients: 960

About SGLT2 inhibitors and empagliflozin

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.

Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/type-1-diabetes

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Contact:

Boehringer Ingelheim
Dr Petra Kienle
Product Communication Manager
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Eli Lilly and Company
Grant Smith
Manager, Global Business Communications
Email: grant.smith@lilly.com
Phone: +1 (317) 954-9907