A randomized, double blind, placebo-controlled, parallel and multicenter study to evaluate the safety and efficacy of pioglitazone with sulphonyurea in type 2 diabetic patients / 中华内科杂志

ObjectiveTo evaluate the safety and efficacy of 30 mg pioglitazone hydrochloride combined with sulphonyurea in the treatment of type 2 diabetic patients.MethodsA 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(HbA1 c) 7.0％ -12.0％,treated with stable dosage of a sulphonyurea for at least 30 days previously, were randomized to receive placebo or pioglitazone 30 mg once daily for 16 weeks.The sulphonyurea and dosage remained unchanged.ResultsThe 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 HbAlc [(0.92 ±0.10)％ vs (0.28 ±0.11)％, P＜0.05].Since fasting plasma insulin (Flns) 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).ConclusionsThe 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 sulphonyurea in Chinese type 2 diabetic patients previously poorly controlled by single sulphonyurea therapy, and furthermore had good safety and compliance.

The effect of rosiglitazone combined with insulin on plasma aldosterone in diabetes patients / 中国糖尿病杂志

Objective To investigate if edema caused by rosiglitazone is associated with the change of aldosterone level. Methods Plasma aldosterone levels in different periods from patients treated with rosiglitazone combined with insulin were measured.Type 2 diabetes patients who have been treated with insulin alone were divided into two groups: patients treated with rosiglitazone(4mg/d) combined with insulin(RSG+insulin group), or treated with insulin alone (insulin group)(n=10). Aldosterone levels, incidence of edema and weight gain were monitored every two months during six months. Results The incidence of edema and weight gain were higher in RSG+insulin group than in insulin group. After two months, aldosterone levels were higher in RSG+insulin group than in insulin group[(77.8±25.9)vs(60.2±27.6)pg/ml,P＞0.05],but it had no statistical difference; after four months, aldosterone levels were higher in RSG+insulin group than in insulin group[(87.2±27.1)vs (61.5±25.6) pg/ml,P＜0.05]. After six months, aldosterone level recovered gradually,it had no statistical difference compared with that of control[(77.0±21.0)vs(69.6±21.7) pg/ml,P＞0.05]. Conclusions The cause of early edema in type 2 diabetic patients treated with rosiglitazone combined with insulin was probably assosiated with elevated aldosterone level.