[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).

CONCLUSION: 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.