Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study.
Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study.
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DOI：
10.1186/s12933-014-0169-9
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发表时间：
2015-01-30
影响因子：
9.3
通讯作者：
Broedl UC
中科院分区：
文献类型：
--
作者：
Nishimura R;Tanaka Y;Koiwai K;Inoue K;Hach T;Salsali A;Lund SS;Broedl UC
本研究评价了恩格列净对日本2型糖尿病（T2DM）患者餐后血糖（PPG）和24小时血糖变异性的影响。患者（N = 60;基线平均[SD] HbA1c 7.91 [0.80] %;体重指数24.3 [3.2] kg/m2）随机接受恩格列净10 mg（n = 20）、恩格列净25 mg（n = 19）或安慰剂（n = 21），每日一次单药治疗，持续28天。在基线和第1天和第28天进行了进餐耐量试验和24小时动态血糖监测（CGM）。主要终点为第28天早餐后3小时葡萄糖浓度-时间曲线下面积（PPG的AUC 1 - 4h）较基线的变化。第1天PPG AUC 1 - 4h较基线变化与安慰剂相比的校正平均（95%）差异为− 97.1恩格列净10 mg组为（− 126.5，− 67.8）mg·h/dl，恩格列净10 mg组为− 91.6（− 120.4，− 62.8）mg·h/dl，恩格列净25 mg（与安慰剂相比，p <0.001），第28天为-85.5恩格列净10 mg组为（− 126.0，− 45.0）mg·h/dl，恩格列净25 mg组为− 104.9（− 144.8，− 65.0）mg·h/dl（与安慰剂相比，p均<0.001）。第1天24小时平均血糖（CGM）较基线变化与安慰剂相比的校正平均（95% CI）差异为-20.8恩格列净10 mg组为（− 27.0，− 14.7）mg/dl，恩格列净10 mg组为− 23.9（− 30.0，− 17.9）mg/dl，恩格列净25 mg（与安慰剂相比，p <0.001），第28天为-24.5恩格列净10 mg组为（− 35.4，− 13.6）mg/dl，恩格列净25 mg组为− 31.7（− 42.5，-20.9）mg/dl（与安慰剂相比，p均<0.001）。在任一时间点，任一恩格列净剂量组与安慰剂组血糖波动平均幅度（法师; CGM）较基线的变化均无显著差异。安慰剂组的平均血糖（CGM）曲线在基线和第1天或第28天之间没有变化，但恩格列净组向下移动。恩格列净10 mg组血糖≥ 70至<180 mg/dl的时间百分比从基线时的52.0%增加至第28天的77.0%，恩格列净25 mg组从55.0%增加至81.1%，而低血糖时间未增加。恩格列净治疗28天可降低日本T2DM患者从第一天开始的PPG，并改善每日血糖控制。Clinicaltrials.gov
This study evaluated the effect of empagliflozin on postprandial glucose (PPG) and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus (T2DM). Patients (N = 60; baseline mean [SD] HbA1c 7.91 [0.80]%; body mass index 24.3 [3.2] kg/m2) were randomized to receive empagliflozin 10 mg (n = 20), empagliflozin 25 mg (n = 19) or placebo (n = 21) once daily as monotherapy for 28 days. A meal tolerance test and continuous glucose monitoring (CGM) for 24 hours were performed at baseline and on days 1 and 28. The primary endpoint was change from baseline in area under the glucose concentration-time curve 3 hours after breakfast (AUC1–4h for PPG) at day 28. Adjusted mean (95%) differences versus placebo in changes from baseline in AUC1-4h for PPG at day 1 were −97.1 (−126.5, −67.8) mg · h/dl with empagliflozin 10 mg and −91.6 (−120.4, −62.8) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were −85.5 (−126.0, −45.0) mg · h/dl with empagliflozin 10 mg and −104.9 (−144.8, −65.0) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Adjusted mean (95% CI) differences versus placebo in change from baseline in 24-hour mean glucose (CGM) at day 1 were −20.8 (−27.0, −14.7) mg/dl with empagliflozin 10 mg and −23.9 (−30.0, −17.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were −24.5 (−35.4, −13.6) mg/dl with empagliflozin 10 mg and −31.7 (−42.5,-20.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Changes from baseline in mean amplitude of glucose excursions (MAGE; CGM) were not significantly different with either empagliflozin dose versus placebo at either timepoint. Curves of mean glucose (CGM) did not change between baseline and day 1 or 28 with placebo, but shifted downward with empagliflozin. Percentage of time with glucose ≥70 to <180 mg/dl increased from 52.0% at baseline to 77.0% at day 28 with empagliflozin 10 mg and from 55.0% to 81.1% with empagliflozin 25 mg, without increasing time spent with hypoglycemia. Empagliflozin for 28 days reduced PPG from the first day and improved daily blood glucose control in Japanese patients with T2DM. Clinicaltrials.gov NCT01947855 The online version of this article (doi:10.1186/s12933-014-0169-9) contains supplementary material, which is available to authorized users.
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影响因子：
5.1
作者：
Guariguata, L.;Whiting, D. R.;Shaw, J. E.
通讯作者：
Shaw, J. E.
DOI：
10.1136/bmj.b4909
发表时间：
2010-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Bonds DE;Miller ME;Bergenstal RM;Buse JB;Byington RP;Cutler JA;Dudl RJ;Ismail-Beigi F;Kimel AR;Hoogwerf B;Horowitz KR;Savage PJ;Seaquist ER;Simmons DL;Sivitz WI;Speril-Hillen JM;Sweeney ME
通讯作者：
Sweeney ME
影响因子：
16.2
作者：
Häring HU;Merker L;Seewaldt-Becker E;Weimer M;Meinicke T;Woerle HJ;Broedl UC;EMPA-REG METSU Trial Investigators
通讯作者：
EMPA-REG METSU Trial Investigators
影响因子：
5.8
作者：
Cavalot, F;Petrelli, A;Trovati, M
通讯作者：
Trovati, M
影响因子：
3.8
作者：
Kadowaki, Takashi;Haneda, Masakazu;Broedl, Uli C.
通讯作者：
Broedl, Uli C.