Buse J B, Gumbiner B, Mathias N P, Nelson D M, Faja B W, Whitcomb R W
Department of Medicine, Diabetes Care Center, University of North Carolina, Chapel Hill, USA.
Diabetes Care. 1998 Sep;21(9):1455-61. doi: 10.2337/diacare.21.9.1455.
To determine the ability of troglitazone to reduce requirements for injected insulin while maintaining blood glucose levels in insulin-treated patients with type 2 diabetes.
This 26-week double-blind study with open-label extension included patients who had failed previous oral antidiabetic medication and took > or =30 but <150 U of insulin daily The 222 patients in the double-blind study received 200 or 400 mg troglitazone once daily or matching placebo. The primary end point was the proportion of patients meeting the target of > or =50% reduction in injected insulin and either a 15% reduction in fasting blood glucose or a blood glucose <7.8 mmol/l. Insulin dose was reduced 25% based on a study-specific algorithm whenever fasting blood glucose was reduced 5% from baseline. Also of interest were changes in insulin dose and HbA1c. The open-label extension included 173 patients. They received 200 mg of troglitazone with optional titration to 400 mg, and insulin dose was adjusted based on investigators' standards of care. Open-label measures were change in insulin dose, HbA1c, and fasting serum glucose (FSG).
In the double-blind phase, 22 and 27% of the 200- and 400-mg troglitazone groups, respectively, reached target, compared with placebo (7%) (P < 0.01). Insulin dose reductions of 13 +/- 3, 30 +/- 3, and 41 +/- 3 U were observed for placebo, 200-, and 400-mg troglitazone groups, respectively HbA1c decreased 0.09 +/- 0.14% for placebo, 0.13 +/- 0.14% for 200 mg, and 0.41 +/- 0.14% for 400 mg (P < 0.05) troglitazone. In the open-label extension, troglitazone treatment resulted in >50% reduction from baseline in daily insulin dose and decreases in HbA1c of 1% and in FSG of >17%.
Troglitazone decreases daily injected insulin dose requirements and improves glycemic control in insulin-treated patients with type 2 diabetes.
确定曲格列酮在维持2型糖尿病胰岛素治疗患者血糖水平的同时降低胰岛素注射需求量的能力。
这项为期26周的双盲研究及开放标签延长期研究纳入了之前口服抗糖尿病药物治疗失败且每日胰岛素用量≥30单位但<150单位的患者。双盲研究中的222名患者每日接受一次200毫克或400毫克曲格列酮或匹配的安慰剂治疗。主要终点是达到胰岛素注射量减少≥50%且空腹血糖降低15%或血糖<7.8毫摩尔/升目标的患者比例。只要空腹血糖较基线降低5%，胰岛素剂量就根据特定研究算法降低25%。胰岛素剂量和糖化血红蛋白（HbA1c）的变化也受到关注。开放标签延长期纳入了173名患者。他们接受200毫克曲格列酮治疗，可选择滴定至400毫克，胰岛素剂量根据研究者的护理标准进行调整。开放标签阶段的测量指标为胰岛素剂量、HbA1c和空腹血清葡萄糖（FSG）的变化。
在双盲阶段，200毫克和400毫克曲格列酮组分别有22%和27%的患者达到目标，而安慰剂组为7%（P<0.01）。安慰剂组、200毫克和400毫克曲格列酮组的胰岛素剂量分别降低了13±3、30±3和41±3单位。安慰剂组的HbA1c降低了0.09±0.14%，200毫克组降低了0.13±0.14%，400毫克曲格列酮组降低了0.41±0.14%（P<0.05）。在开放标签延长期，曲格列酮治疗使每日胰岛素剂量较基线降低>50%，HbA1c降低1%，FSG降低>17%。
曲格列酮可降低2型糖尿病胰岛素治疗患者的每日胰岛素注射需求量，并改善血糖控制。
