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news.Boehringer Ingelheim and Eli Lilly and Company presented results from a 52-week Phase III study that demonstrated sustained efficacy of the investigational empagliflozin/linagliptin combination tablet in adults with type 2 diabetes (T2D) already taking metformin and in those who were previously untreated.
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Results from the study, presented during the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD), also confirmed the safety profile of the combination tablet.
"We are encouraged by the results of this study because it showed clinically meaningful reductions in blood glucose levels with the empagliflozin/linagliptin combination when used with or without metformin," said Prof Hans-J. Woerle, Vice President, Head of medicine, Therapeutic Area Metabolism, Boehringer Ingelheim. "As Type 2 Diabetes is a complex and progressive condition, new treatment approaches may be required to help control blood glucose and the single tablet combination of empagliflozin/linagliptin may provide an important option for these patients."
About the study
In the parallel group study, 1,363 adults with T2D were randomised to five groups to investigate the efficacy and safety of two doses of the empagliflozin/linagliptin combination tablet compared to two doses of empagliflozin and one dose of linagliptin with or without metformin. Overall, empagliflozin/linagliptin combination therapy was well tolerated, with safety profiles similar to those known for the individual components. Patients were randomised to one the following treatments:
Empagliflozin 25mg/linagliptin 5mg, combination tablet
Empagliflozin 10mg/linagliptin 5mg, combination tablet
Empagliflozin 25mg
Empagliflozin 10mg
Linagliptin 5mg
Empagliflozin/linagliptin combination therapy as add-on to stable dose metformin
In April this year, Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly announced the U.S. Food and Drug Administration (FDA) accepted the filing of the New Drug Application for the investigational oral combination of empagliflozin/linagliptin in a single tablet for the treatment of T2D. If granted approval by the FDA, this combination will bring together, for the first time into one tablet, the distinct mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor.