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- Title
Henagliflozin monotherapy in patients with type 2 diabetes inadequately controlled on diet and exercise: A randomized, double‐blind, placebo‐controlled, phase 3 trial.
- Authors
Lu, Juming; Fu, Liujun; Li, Yan; Geng, Jianlin; Qin, Li; Li, Ping; Zheng, Hailong; Sun, Zilin; Li, Yanbing; Zhang, Lihui; Sun, Yadong; Chen, Daoxiong; Qin, Guijun; Lu, Weiping; Guo, Yushan; Zhang, Yuwei; Liu, Haiyan; Zhang, Tao; Zou, Jianjun
- Abstract
Aim: To evaluate henagliflozin, a novel sodium‐glucose co‐transporter‐2 inhibitor, as monotherapy in patients with type 2 diabetes and inadequate glycaemic control with diet and exercise. Materials and Methods: This multicentre trial included a 24‐week, randomized, double‐blind, placebo‐controlled period, followed by a 28‐week extension period. Four hundred and sixty‐eight patients with an HbA1c of 7.0%–10.5% were randomly assigned (1:1:1) to receive once‐daily placebo, or 5 or 10 mg henagliflozin. After 24 weeks, patients on placebo were switched to 5 or 10 mg henagliflozin, and patients on henagliflozin maintained the initial therapy. The primary endpoint was the change in HbA1c from baseline after 24 weeks. Results: At Week 24, the placebo‐adjusted least squares (LS) mean changes from baseline in HbA1c were −0.91% (95% CI: −1.11% to −0.72%; P <.001) and −0.94% (−1.13% to −0.75%; P <.001) with henagliflozin 5 and 10 mg, respectively; the placebo‐adjusted LS mean changes were −1.3 (−1.8 to −0.9) and −1.5 (−2.0 to −1.1) kg in body weight, and −5.1 (−7.2 to −3.0) and −4.4 (−6.5 to −2.3) mmHg in systolic blood pressure (all P <.05). The trends of these improvements were sustained for an additional 28 weeks. Adverse events occurred in 81.0%, 78.9% and 78.9% of patients in the placebo, henagliflozin 5 and 10 mg groups, respectively. No diabetic ketoacidosis or major episodes of hypoglycaemia occurred. Conclusions: Henagliflozin 5 mg and 10 mg as monotherapy provided effective glycaemic control, reduced body weight and blood pressure, and was generally well tolerated.
- Subjects
TYPE 2 diabetes; SYSTOLIC blood pressure; GLYCEMIC control; DIABETIC acidosis; BLOOD pressure; EXERCISE tolerance; SALT-free diet
- Publication
Diabetes, Obesity & Metabolism, 2021, Vol 23, Issue 5, p1111
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.14314