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Efficacy and safety of janagliflozin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled on diet and exercise: A multicentre, randomized, double‐blind, placebo‐controlled, Phase 3 trial

Efficacy and safety of janagliflozin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled on diet and exercise: A multicentre, randomized, double‐blind, placebo‐controlled, Phase 3 trial

Authors :
Linong Ji
Xiaozhen Jiang
Qingshun Hao
Zhifeng Cheng
Kun Wang
Shuguang Pang
Meiying Liu
Yushan Guo
Xiaowen Chen
Xiuhai Su
Tao Ning
Jie Liu
Fang Bian
Yulan Li
Zhinong Zhang
Weihong Song
Jingfang Sun
Source :
Diabetes, Obesity and Metabolism. 25:1229-1240
Publication Year :
2023
Publisher :
Wiley, 2023.

Abstract

To evaluate the efficacy and safety of janagliflozin, a selective inhibitor of the renal sodium-glucose cotransporter-2, as monotherapy in drug-naive Chinese patients with type 2 diabetes mellitus (T2DM).This phase 3 trial included a 24-week, multicenter, randomized, double-blind, placebo-controlled period, followed by a 28-week extension period. 432 patients with HbAAt Week 24, the placebo-adjusted LS mean changes of HbAJanagliflozin 25 mg and 50 mg monotherapy once-daily effectively improved glycemic control, reduced body weight and blood pressure, improved HDL-C and insulin sensitivity, and was generally well-tolerated.NCT03811548 This article is protected by copyright. All rights reserved.

Details

ISSN :
14631326 and 14628902
Volume :
25
Database :
OpenAIRE
Journal :
Diabetes, Obesity and Metabolism
Accession number :
edsair.doi.dedup.....242ed4d12dabf2fa8875b3b2e705e120
Full Text :
https://doi.org/10.1111/dom.14971