[The efficacy and safety of pioglitazone hydrochloride in combination with sulphonylureas and metfomin in the treatment of type 2 diabetes mellitus a 12-week randomized multi-centres placebo-controlled parallel study].
OBJECTIVE
To evaluate the efficacy and safety of pioglitazone hydrochloride 30 mg/day with sulphonylureas and metfomin in the treatment of patients with type 2 diabetes mellitus.


METHODS
There were 283 patients treated with sulphonylureas and metfomin randomized in this multicenter double-blind placebo-controlled clinical trial. Patients who had 7.0 mmol/L </= fasting plasma glucose(FPG) < 13.0 mmol/L were randomized to receive placebo or pioglitazone 30 mg once daily for 12 weeks.


RESULTS
The patients who had been treated with pioglitazone 30 mg showed significant decrease on average from baseline in FPG(1.1 mmol/L versus 0.4 mmol/L, P < 0.001), postprandial plasma glucose(PPG,1.5 mmol/L versus 0.3 mmol/L, P < 0.001), and glycosylated hemoglobin (HbA1c, 0.7% versus 0.4%, P < 0.01). AS for fasting plasma insulin (FIns) levels decreased, significant difference was also observed in the two groups (P < 0.05). HOMA-IR had significant mean decrease in the pioglitazone group as compared with placebo group (P < 0.01).


CONCLUSIONS
Pioglitazone 30 mg/day for 12 weeks might improve the metabolic control and the insulin sensitivity in poorly controlled type 2 diabetes with previous administration of sulphonylureas and metfomin. It provides a safety and tolerance profile for type 2 diabetes mellitus in this trial.
Pan
Changyu
C
Department of Endocrinology, General Hospital of PLA, Beijing 100853, China.
Gao
Yan
Y
Gao
Xin
X
Li
Guangwei
G
Luo
Bangyao
B
Shi
Hongli
H
Tian
Hui
H
Jia
Peihong
P
Lin
Huandong
H
Xing
Xiaoyan
X
Zhao
Yongju
Y
Zhou
Linuo
L
D001794:Blood Pressure; D001835:Body Weight; D002784:Cholesterol / Q000097:blood; D003257:Consumer Product Safety; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006339:Heart Rate; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D045162:Thiazolidinediones; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D007004:Hypoglycemic Agents; D007328:Insulin; D013453:Sulfonylurea Compounds; D013844:Thiazoles; D045162:Thiazolidinediones; D014280:Triglycerides; D008687:Metformin; D002784:Cholesterol; D000077205:Pioglitazone