Efficacy and safety of ipragliflozin as an add-on to a sulfonylurea in Japanese patients with inadequately controlled type 2 diabetes: results of the randomized, placebo-controlled, double-blind, phase III EMIT study

Sulfonylureas are often used alone or in combination with other drugs for treating type 2 diabetes. Ipragliflozin is a sodium/glucose cotransporter 2 inhibitor that enhances urinary glucose excretion and improves glycemic control. We examined the efficacy and safety of ipragliflozin as an add-on to a sulfonylurea in Japanese type 2 diabetes patients with inadequate glycemic control in a phase III study. Patients were randomized, double-blind, to 50 mg ipragliflozin or placebo for 24 weeks, followed by a 28-week open-label extension in which all patients received either 50 or 100 mg ipragliflozin. The primary endpoint was the change in HbA1c from baseline to week 24 (last observation carried forward). Overall, 166 patients were prescribed ipragliflozin and 77 were prescribed placebo. The adjusted mean change in HbA1c from baseline to week 24 between the ipragliflozin and placebo groups was −1.14 % (P < 0.001). The reductions in fasting plasma glucose and body weight were significantly greater in the ipragliflozin group (placebo-adjusted mean change: −38.0 mg/dl and −1.32 kg, respectively; both, P < 0.001). These changes were maintained until the end of the open-label extension. There were more treatment-emergent adverse events in the ipragliflozin group than in the placebo group (75.9 vs. 61.8 %; P = 0.032). The most common adverse events with a higher incidence in the ipragliflozin group than in the placebo group were mild pollakiuria and thirst. Ipragliflozin as an add-on to a sulfonylurea significantly improved glycemic control and reduced body weight, with good tolerability, in Japanese type 2 diabetes patients.