Efficacy and Safety of Generic and Original Pioglitazone in Type 2 Diabetes Mellitus: A Multicenter, a Double-Blinded, Randomized-Controlled Study
Petch Rawdaree MD*, Chaicharn Deerochanawong MD**, Thavatchai Peerapatdit MD***, Nuntakorn Thongtang MD***, Sompongse Suwanwalaikorn MD****, Ampai Khemkha MD****, Yupin Benjasuratwong MD*****, Apussanee Boonyavarakul MD*****, Thanya Chetthakul MD******, Rattana Leelawattana MD*******, Chardpraorn Ngarmukos MD********, Chukiat Viwatwongkasem PhD*********, Thongchai Pratipanawatr MD**********, Natapong Kosachunhanun MD***********
Affiliation : * BMA Medical College and Vajira Hospital, Bangkok, Thailand ** Rajavithi Hospital, Bangkok, Thailand *** Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand **** Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thaialnd ***** Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand ****** Department of Medicine, Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, Thailand ******* Department of Medicine, Faculty of Medicine, Prince of Songkhla University, Songkhla, Thailand ******** Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand *********Department of Biostatistics, Faculty of Public Health, Mahidol University, Bangkok, Thailand ********** Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand *********** Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Objective : 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.
Material and Method: Type 2 diabetic patients, with glycosylated hemoglobin (HbA1c) > 7.0%, who received Metformin not
less than 1,000 mg/day over three months were recruited. Patients were randomized to receive either generic or original
Pioglitazone 30 mg/day for 24 weeks.
Results : Eighty-five patients were enrolled, forty-four patients received generic Pioglitazone and forty-one received original
Pioglitazone. There were no significant differences in baseline characteristics between generic and original Pioglitazone
group. There were significantly reduced HbA1c, fasting plasma glucose (FPG) and significantly increased HDL-cholesterol
from baseline (p < 0.0001) without statistically differences between the two groups. Headache and edema were found in both
groups at comparable rates (p > 0.05).
Conclusion : Generic Pioglitazone (Utmos®) is effective in controlling blood glucose and has similar effects on lipid profile
as the original one. Both generic (Utmos®) and original (Actos®) 30 mg Pioglitazone tablets were not different in the efficacy
and safety profiles.
Keywords : Pioglitazone, Thiazolidinedione, Generic, Diabetes mellitus, Type 2
