Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections of Insulin in Obese Inadequately Controlled Type 2 Diabetes-猫眼课题宝

DOI：

10.2337/dc13-3055

发表时间：

2014-07-01

期刊：

DIABETES CARE

影响因子：

16.2

通讯作者：

中科院分区：

医学1区

文献类型：

作者：

Rosenstock, Julio;Jelaska, Ante;Broedl, Uli C.

目的：我们研究了在肥胖2型糖尿病(T2 DM)患者每日多次注射胰岛素(MDI Ins)的基础上加用钠葡萄糖转运蛋白2(Ins-Glug CoTransporter 2)抑制剂的有效性和安全性。研究设计与方法未能充分控制MDI胰岛素+/-二甲双胍(平均糖化血红蛋白(1c)8.3%[67 mmol/mol]；BMI 34.8 kg/m(2)；胰岛素剂量92国际单位/天)的患者随机分为3组，每日1次，分别给予10 mg(n=186)、25 mg(n=189)或188(n=188)安慰剂治疗52周。胰岛素剂量在第1-18周保持稳定，在第19-40周调整到达到血糖目标，然后在第41-52周稳定。主要终点是在18周时糖化血红蛋白(1c)较基线的变化。次要终点是胰岛素剂量、体重、结果糖化血红蛋白(1c)的调整后平均+/-SE变化在第18周时安慰剂组为-0.50+/-0.05%(-5.56+/-0.5 mm o l/m ol)，而安慰剂组为-0.94+/-0.05%(-10.3+/-0.5 m o l/m o l)和-1.02+/-0.05%(-11.1+/-0.5 m ol/m o l)；0.001)。在第52周，胰岛素滴定的进一步降低导致糖化血红蛋白(1c)较基线分别变化20.81+/-0.08%(-8.9+/-0.9 mm o l/m ol)、-1.18+/-0.08%(-12.9+/-0.9 m ol/m ol)和-1.27+/-0.08%(-13.9+/-0.9 m ol/m ol)，安慰剂、依帕格列酮10 mg和依帕利平25 mg，HbA(1c)分别为7.5%(58 mm o l/m ol)、7.2%(55 m o l/m ol)和7.1%(54 m o l/m ol)。更多的患者达到了HBA(1c)&lt；7%(

OBJECTIVEWe investigated the efficacy and safety of the sodium glucose cotransporter 2 inhibitor, empagliflozin, added to multiple daily injections of insulin (MDI insulin) in obese patients with type 2 diabetes mellitus (T2DM).RESEARCH DESIGN AND METHODSPatients inadequately controlled on MDI insulin +/- metformin (mean HbA(1c) 8.3% [67 mmol/mol]; BMI 34.8 kg/m(2); insulin dose 92 international units/day) were randomized and treated with once-daily empagliflozin 10 mg (n = 186), empagliflozin 25 mg (n = 189), or placebo (n = 188) for 52 weeks. Insulin dose was to remain stable in weeks 1-18, adjusted to meet glucose targets in weeks 19-40, then stable in weeks 41-52. The primary end point was change from baseline in HbA(1c) at week 18. Secondary end points were changes from baseline in insulin dose, weight, and HbA(1c) at week 52.RESULTSAdjusted mean +/- SE changes from baseline in HbA(1c) were -0.50 +/- 0.05%(-5.56 +/- 0.5 mmol/mol) for placebo versus -0.94 +/- 0.05% (-10.3 +/- 0.5 mmol/mol) and -1.02 +/- 0.05% (-11.1 +/- 0.5 mmol/mol) for empagliflozin 10 mg and empagliflozin 25 mg, respectively, at week 18 (both P < 0.001). At week 52, further reductions with insulin titration resulted in changes from baseline in HbA(1c) of 20.81 +/- 0.08%(-8.9 +/- 0.9 mmol/mol), -1.18 +/- 0.08%(-12.9 +/- 0.9 mmol/mol), and -1.27 +/- 0.08%(-13.9 +/- 0.9 mmol/mol) with placebo, empagliflozin 10 mg, and empagliflozin 25 mg, respectively, and final HbA(1c) of 7.5% (58 mmol/mol), 7.2% (55 mmol/mol), and 7.1% (54 mmol/mol), respectively. More patients attained HbA(1c) < 7% (

Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections of Insulin in Obese Inadequately Controlled Type 2 Diabetes

文献摘要

被引文献

相似文献