One-pill combo reduces blood glucose significantly in T2DM

The Boerhringer Ingleheim-Eli Lilly Diabetes Alliance presented more than 40 posters, abstracts, and oral presentations June 13-17 at the 74th American Diabetes Association (ADA) Scientific Sessions in San Francisco. 

Christophe Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim, shared the results of two combination therapy phase 3 studies: the investigational compound empagliflozin (EMPA) paired with linagliptin (LINA) in fixed-dose combinations and delivered in one pill, the first such combination therapy for diabetes filed with the FDA. The combination therapy was studied in drug-naive patients with type 2 diabetes and as add-on therapy to metformin in type 2 diabetes patients.

EMPA is a sodium glucose co-transporter-2 (SGLT2) inhibitor that removes excess glucose through the urine by blocking glucose re-absorption in the kidney. LINA, a dipeptidyl peptidase-4 (DPP-4) inhibitor is marketed in the United States as Tradjenta 5 mg tablets, and used to improve glycemic control in adults with type 2 diabetes.

According to Arbet-Engels, the results of these studies forecast a new approach to type 2 diabetes therapy of both ongoing treatment and drug-naive patients.

Compelling results

Patients in each study were randomized to treatment with fixed-dose combination of EMPA 25 mg/LINA 5 mg, EMPA 10 mg/LINA 5 mg; and monotherapies EMPA 25 mg, EMPA 10 mg, and LINA 5 mg. The primary end point in the investigations was change in baseline at week 24 of HbA1c; changes in fasting blood glucose (FPG) and weight were key secondary end points.

In both studies, significantly more adults who had HbA1c levels greater than 7.0% at baseline achieved A1c levels of less than 7.0% after 24 weeks with both doses of the EMPA/LINA combination vs. either EMPA or LINA alone.

The BI-Lilly Diabetes alliance is “the first one to have this combination therapy now filed with the FDA,” said Arbet-Engels. “This one-pill combination targets two different physiologies of diabetes, both the insulin secretion and blood glucose aspect, and we believe this offers physicians an important solution to individualize therapy of their type 2 [diabetes] patients."