"Efficacy and safety of empagliflozin in combination with insulin in Chinese patients with type 2 diabetes and insufficient glycaemic control: A phase III, randomized, double-blind, placebo-controlled, parallel study"

作者全名："Ji, Linong; Lu, Yibin; Li, Qifu; Fu, Liujun; Luo, Yong; Lei, Tao; Li, Ling; Ye, Shandong; Shi, Bimin; Li, Xiyan; Meinicke, Thomas"

作者地址："[Ji, Linong] Peking Univ Peoples Hosp, Dept Endocrinol & Metab, Beijing, Peoples R China; [Lu, Yibin] Nanjing Med Univ, Dept Endocrinol, Affiliated Hosp 2, Nanjing, Peoples R China; [Li, Qifu] Chongqing Med Univ, Dept Endocrinol, Affiliated Hosp 1, Chongqing, Peoples R China; [Fu, Liujun] Henan Univ Sci & Technol, Dept Endocrinol, Affiliated Hosp 1, Luoyang, Peoples R China; [Luo, Yong] Chongqing Univ Three Gerges Hosp, Dept Endocrinol, Chongqing, Peoples R China; [Lei, Tao] Putuo Dist Cent Hosp Shanghai, Dept Endocrinol, Shanghai, Peoples R China; [Li, Ling] China Med Univ, Dept Endocrinol, Shengjing Hosp, Shenyang, Peoples R China; [Ye, Shandong] USTC, Dept Endocrinol, Affiliated Hosp 1, Hefei, Peoples R China; [Shi, Bimin] Soochow Univ, Dept Endocrinol, Affiliated Hosp 1, Suzhou, Peoples R China; [Li, Xiyan] Boehringer Ingelheim China Investment Co Ltd, Biostat & Data Sci, Shanghai, Peoples R China; [Meinicke, Thomas] Boehringer Ingelheim Int GmbH, Therapeut Area Cardiovasc Metab Resp, Ingelheim, Germany; [Ji, Linong] Peking Univ Peoples Hosp, Dept Endocrinol & Metab, 11 Xizhimen South St, Beijing 100044, Peoples R China"

通信作者："Ji, LN (通讯作者)，Peking Univ Peoples Hosp, Dept Endocrinol & Metab, 11 Xizhimen South St, Beijing 100044, Peoples R China."

来源：DIABETES OBESITY & METABOLISM

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000957832400001

JCR分区：Q1

影响因子：5.8

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：Chinese patients; empagliflozin; glycaemic control; insulin therapy; type 2 diabetes

摘要："Aim: To evaluate the efficacy and safety of empagliflozin in combination with insulin +/- oral antidiabetic drugs (OADs) over 24 weeks, in Chinese patients with type 2 diabetes (T2D) who had insufficient glycaemic control. Materials and Methods: This was a randomized, double-blind, placebo-controlled, parallel group, multicentre phase III study. Adult patients with T2D and insufficient glycaemic control who received insulin +/- up to two OADs were randomized (1:1:1) to receive empagliflozin 10 or 25 mg, or placebo for 24 weeks. The primary endpoint was change from baseline in HbA1c at week 24. Results: Of 219 randomized patients, 73 patients were in each treatment group; baseline characteristics were comparable among the groups. There was a significantly larger decrease from baseline in HbA1c (adjusted mean treatment difference -0.99 and -0.98 for in the empagliflozin 10 and 25 mg groups, respectively; P < .0001) with both doses of empagliflozin than with placebo. There were also significantly larger decreases from baseline in fasting plasma glucose, 2-hour postprandial glucose and body weight with both empagliflozin doses than with placebo. Among patients in the empagliflozin 10 mg, 25 mg and placebo groups, 17.8%, 9.6% and 11.0% reported confirmed hypoglycaemic events, respectively (nominal P = .2422 and .7661 in the empagliflozin 10 and 25 mg groups, respectively), and no Clinical Events Committee-confirmed diabetic ketoacidosis events were reported. Conclusions: In Chinese patients with T2D, empagliflozin combined with insulin +/- OADs improved glycaemic control and was well tolerated, without an increased risk of hypoglycaemia."

基金机构：Boehringer Ingelheim

基金资助正文：Boehringer Ingelheim