Boehringer Ingelheim and Eli Lilly have reported positive top-line results from four completed Phase III clinical trials of type 2 diabetes drug empagliflozin.
Empagliflozin is an investigational sodium glucose co-transporter-2 inhibitor being studied for treatment of patients with type 2 diabetes.
All the four studies met the primary efficacy endpoint of significant change in HbA1c from baseline compared to placebo with empagliflozin 10mg and 25mg once-daily doses.
Boehringer Ingelheim medicine corporate senior vice president Professor Klaus Dugi said; "Many patients with type 2 diabetes are not meeting their blood sugar level goals, and alternative treatment options are needed for them."
The trials were Study 1245.20, Study 1245.23, Study 1245.19 and Study 1245.36.
Study 1245.20 (n=986) evaluated 10mg and 25mg doses of empagliflozin as monotherapy versus placebo for 24 weeks, while Study 1245.23 compared 10mg and 25mg doses of empagliflozin as an add-on to metformin and metformin plus sulfonylurea versus placebo for 24 weeks.
Study 1245.19 (n=499) evaluated 10mg and 25mg doses of empagliflozin as an add-on to pioglitazone and pioglitazone plus metformin against placebo for 24 weeks.
A 25mg dose of empagliflozin was assessed in Study 1245.36 in patients with type 2 diabetes with mild, moderate or severe renal impairment, and 10mg dose in those with mild renal impairment versus placebo for 52 weeks.
A similar adverse event profile was established for placebo and empagliflozin 10mg and 25g. The safety information is consistent with findings from empagliflozin Phase II studies.
Lilly Diabetes president Enrique Conterno said; "Diabetes is growing at a tremendous rate across the world. Patients and their physicians need more treatment options in order to help improve their blood sugar levels and reach their treatment goals."
Boehringer Ingelheim and Lilly expect to file for regulatory review in the US, Europe and Japan in 2013.
Image: Eli Lilly and Boehringer Ingelheim announced encouraging efficacy and safety results for empagliflozin. Photo: Courtesy of Guanaco152003.