An investigational sodium glucose cotransporter-2 (SGLT2) inhibitor, empagliflozin (Boehringer Ingelheim), lowered glucose to a similar degree as metformin and also produced sustained weight loss for up to 90 weeks in an open-label extension study in patients with type 2 diabetes. The data were presented during a late-breaking clinical-trial session on May 5 at the American Association of Clinical Endocrinologists (AACE) 2013 Scientific & Clinical Congress by Thomas Hach, MD, senior medical director, Boehringer Ingelheim, Germany.

Empagliflozin is one of a new class of glucose-lowering drugs, the oral SGLT2 inhibitors, which produce increased urinary glucose excretion, with a consequent lowering of plasma glucose levels, as well as weight loss. A New Drug Application (NDA) has been submitted to the US FDA for empagliflozin, and a decision is expected in the first quarter of 2014.

Dr. Hach presented data from a randomized, 78-week extension study that followed 2 separate 12-week randomized controlled trials. In 1 trial, patients were randomized to 10-mg or 25-mg empagliflozin or to metformin, as monotherapy, in 81, 82, and 80 patients, respectively. The second study randomized 71, 70, and 71 patients, respectively, to empagliflozin 10 mg or 25 mg or to sitagliptin as an add-on to metformin.At 90 weeks, adjusted mean percentage-point reductions from baseline in HbA1c were 0.51 for empagliflozin 10 mg and 0.60 for 25 mg, compared with 0.64 for metformin as monotherapy.

Urinary-tract infections were also not increased with empagliflozin .However, as has been seen with other SGLT2 inhibitors, rates of genital infection were increased with empagliflozin, 2.5% and 3.7% for the 10-mg and 25-mg doses, respectively, compared with 1.3% with metformin monotherapy and 8.5% and 4.3% vs 1.4% with sitagliptin add-on therapy. Genital infections were seen predominantly in women, and none were severe.