[A randomized, double blind, placebo-controlled, parallel and multicenter study to evaluate the safety and efficacy of pioglitazone with sulphonylurea in type 2 diabetic patients].
OBJECTIVE
To evaluate the safety and efficacy of 30 mg pioglitazone hydrochloride combined with sulphonylurea in the treatment of type 2 diabetic patients.


METHODS
A randomized, double blind, placebo-controlled, parallel group, multicenter study was performed. A total of 236 patients, who had fasting plasma glucose (FPG) 7.5 - 13.0 mmol/L and glycosylated hemoglobin A1c (HbA1c) 7.0% - 12.0%, treated with stable dosage of a sulphonylurea for at least 30 days previously, were randomized to receive placebo or pioglitazone 30 mg once daily for 16 weeks. The sulphonylurea and dosage remained unchanged.


RESULTS
The patients who had been treated with pioglitazone 30 mg showed significant decrease than that in the placebo group on the average from baseline in FPG [(1.48 ± 2.08) mmol/L vs (-0.17 ± 1.92) mmol/L, P < 0.05], and in HbA1c [(0.92 ± 0.10)% vs (0.28 ± 0.11)%, P < 0.05]. Since fasting plasma insulin (FIns) levels decreased (0.24 ± 0.04) mU/L and (0.09 ± 0.04) mU/L in the two groups. The homeostatic model assessment insulin resistant (HOMA-IR) decreased 1.42 ± 2.90 and 0.46 ± 3.53 in two groups. The triglyceride level was decreased 0.36 mmol/L and 0.14 mmol/L, and the HDL-C level increased 0.17 mmol/L and 0.05 mmol/L in two groups. There were significant differences in two groups (all P < 0.05).


CONCLUSIONS
The 16-week clinical study demonstrated that pioglitazone hydrochloride with a dosage of 30mg daily, could significantly improve the blood glucose control and enhance the insulin sensitivity, lower triglyceride and raise HDL-C level as an additional therapy to a stable-dose sulphonylurea in Chinese type 2 diabetic patients previously poorly controlled by single sulphonylurea therapy, and furthermore had good safety and compliance.
Department of Endocrinology, PLA General Hospital, Beijing, China.
Zhao-hui
ZH
Lü
Chang-yu
CY
Pan
Yan
Y
Gao
Li-xin
LX
Guo
Guang
G
Ning
Zhi-min
ZM
Liu
Ju-ming
JM
Lu
Pei-hong
PH
Jia
Xiao-xia
XX
Wang
Shou-Yue
SY
Sun
Jiao-Yang
JY
Zheng
D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D045162:Thiazolidinediones / Q000009:adverse effects / Q000627:therapeutic use*
D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; D000077205:Pioglitazone