Journal of the Medical Association of Thailand Vol 93, No 11:NOVEMBER 2010 0125-2208 93 11 2010 Nov Efficacy and Safety of Generic and Original Pioglitazone in Type 2 Diabetes Mellitus: A Multicenter, a Double-Blinded, Randomized-Controlled Study 1249 EN Petch Rawdaree Chaicharn Deerochanawong Thavatchai Peerapatdit Nuntakorn Thongtang Sompongse Suwanwalaikorn Ampai Khemkha Yupin Benjasuratwong Apussanee Boonyavarakul Thanya Chetthakul Rattana Leelawattana Chardpraorn Ngarmukos Chukiat Viwatwongkasem Thongchai Pratipanawatr Natapong Kosachunhanun Original Article To compare the efficacy and safety of generic (Utmos®) and original (Actos®) 30 mg Pioglitazone tablets.Study design: A multicenter, parallel randomized, double-blinded, controlled study. Type 2 diabetic patients, with glycosylated hemoglobin (HbA1c) > 7.0%, who received Metformin notless than 1,000 mg/day over three months were recruited. Patients were randomized to receive either generic or originalPioglitazone 30 mg/day for 24 weeks. Eighty-five patients were enrolled, forty-four patients received generic Pioglitazone and forty-one received originalPioglitazone. There were no significant differences in baseline characteristics between generic and original Pioglitazonegroup. There were significantly reduced HbA1c, fasting plasma glucose (FPG) and significantly increased HDL-cholesterolfrom baseline (p < 0.0001) without statistically differences between the two groups. Headache and edema were found in bothgroups at comparable rates (p > 0.05). Generic Pioglitazone (Utmos®) is effective in controlling blood glucose and has similar effects on lipid profileas the original one. Both generic (Utmos®) and original (Actos®) 30 mg Pioglitazone tablets were not different in the efficacyand safety profiles. Pioglitazone Thiazolidinedione Generic Diabetes mellitus Type 2