One placebo-controlled, double-blind study was carried out at 18 different sites in Korea and 12 in Taiwan. Patients were above 20 and had type 2 diabetes for atlas 12 weeks. They were given an 8-week period to clear their systems of all other drugs (besides metformin). Patients received either 50 mg ipragliflozin or a placebo. The drugs were identical in all physical forms. The patients were prohibited from using any other anti diabetic drugs, other than metformin. The study ran for 24 weeks along with a 4-week follow-up period.
The standard deviation in hemoglobin A1c were −0.94% and −0.47% in the ipragliflozin and placebo groups, respectively (between-group difference −0.46%, p <0.001). The changes in fasting plasma glucose and bodyweight were also significantly greater in the ipragliflozin group, with between-group differences of −14.1 mg/dL and −1.24 kg, respectively (both p <0.001). The most common adverse events that appeared were upper respiratory infections and urinary tract infections. From this it was concluded that ipragliflozin is both efficacious as well as safe.