Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced top-line results for four completed Phase III clinical trials for empagliflozin, an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor being studied for treatment of patients with Type 2 Diabetes (T2D). In all four studies, the primary efficacy endpoint defined as significant change in HbA1c from baseline compared to placebo, was met with empagliflozin (10 and 25 mg) taken once daily.
These four pivotal studies from the empagliflozin trial programme are:
Study 1245.20 (n=986) evaluated 10 mg and 25 mg doses of empagliflozin as monotherapy versus placebo for 24 weeks.
Study 1245.23 (n=1,504) compared 10 mg and 25 mg doses of empagliflozin as an add-on to metformin and metformin plus sulfonylurea versus placebo for 24 weeks.
Study 1245.19 (n=499) assessed 10 mg and 25 mg doses of empagliflozin as an add-on to pioglitazone and pioglitazone plus metformin versus placebo for 24 weeks.
Study 1245.36 (n=741) evaluated 25 mg dose of empagliflozin in patients with type 2 diabetes with mild, moderate or severe renal impairment, and 10 mg dose in those with mild renal impairment versus placebo for 52 weeks.
Incidence of adverse events was similar for placebo, empagliflozin 10 mg and 25 mg. Genital infections occurred more often with empagliflozin (both dosages) compared with placebo. This safety information is consistent with findings reported in the Phase II study results for empagliflozin.
Empagliflozin is part of a class of drugs being investigated for the reduction of blood glucose levels in adults with T2D. In clinical trials to date, SGLT2 inhibitors have been shown to reduce blood glucose by removing excess glucose independently of beta cell function and insulin resistance.
"Boehringer Ingelheim and Lilly are very encouraged by the efficacy and safety results for empagliflozin," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Many patients with Type 2 Diabetes are not meeting their blood sugar level goals, and alternative treatment options are needed for them. We believe we are now one step closer to bringing a relevant treatment option in a new drug class to these patients."
"We are pleased with these results for these Phase III clinical trials for empagliflozin," said Enrique Conterno, President, Lilly Diabetes. "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."
Empagliflozin is being investigated in adults with T2D in a Phase III clinical trial programme that will enrol over 14,500 patients. In total, this programme comprises 8 multinational clinical trials, including a large cardiovascular outcome trial.
The pivotal studies for empagliflozin completed in 2012, and Boehringer Ingelheim and Lilly anticipate filing for regulatory review in the U.S., Europe and Japan in 2013. Boehringer Ingelheim and Lilly plan to present detailed data disclosures for many of these studies at scientific medical meetings and publications in 2013 and 2014.