Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: a multicenter, a double-blinded, randomized-controlled study.
OBJECTIVE
To compare the efficacy and safety of generic (Utmos) and original (Actos) 30 mg Pioglitazone tablets.


METHODS
A multicenter, parallel randomized, double-blinded, controlled study.


METHODS
Type 2 diabetic patients, with glycosylated hemoglobin (HbA,) > or = 7.0%, who received Metformin not less than 1000 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 andforty-one received original Pioglitazone. There were no significant differences in baseline characteristics between generic and original Pioglitazone group. There were significantly reduced HbA(1c), 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).


CONCLUSIONS
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.
BMA Medical College and Vajira Hospital, Bangkok, Thailand. petch@vajira.ac.th
Petch
P
Rawdaree
Chaicharn
C
Deerochanawong
Thavatchai
T
Peerapatdit
Nuntakorn
N
Thongtang
Sompongse
S
Suwanwalaikorn
Ampai
A
Khemkha
Yupin
Y
Benjasuratwong
Apussanee
A
Boonyavarakul
Thanya
T
Chetthakul
Rattana
R
Leelawattana
Chardpraorn
C
Ngarmukos
Chukiat
C
Viwatwongkasem
Thongchai
T
Pratipanawatr
Natapong
N
Kosachunhanun
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D000077205:Pioglitazone; D045162:Thiazolidinediones / Q000627:therapeutic use*; D016896:Treatment Outcome
D001786:Blood Glucose; D016568:Drugs, Generic; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008055:Lipids; D000077205:Pioglitazone; D045162:Thiazolidinediones