Publication: Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study
Issued Date
2010-11-01
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ISSN
01252208
01252208
01252208
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2-s2.0-78649246535
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of the Medical Association of Thailand. Vol.93, No.11 (2010), 1249-1255
Suggested Citation
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 Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study. Journal of the Medical Association of Thailand. Vol.93, No.11 (2010), 1249-1255. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/29497
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Title
Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study
Author(s)
Abstract
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.