J Med Assoc Thai 2010; 93 (11):1249

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Efficacy and Safety of Generic and Original Pioglitazone in Type 2 Diabetes Mellitus: A Multicenter, a Double-Blinded, Randomized-Controlled Study
Rawdaree P Mail, Deerochanawong C , Peerapatdit T , Thongtang N , Suwanwalaikorn S , Khemkha A , Benjasuratwong Y , Boonyavarakul A , Chetthakul T , Leelawattana R , Ngarmukos C , Viwatwongkasem C , Pratipanawatr T , Kosachunhanun N

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

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