Henagliflozin monotherapy in patients with type 2 diabetes inadequately controlled on diet and exercise: A randomized, double-blind, placebo-controlled, phase 3 trial.
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.
['Lu|Juming|J|', 'Fu|Liujun|L|', 'Li|Yan|Y|', 'Geng|Jianlin|J|', 'Qin|Li|L|', 'Li|Ping|P|', 'Zheng|Hailong|H|', 'Sun|Zilin|Z|', 'Li|Yanbing|Y|0000-0001-7242-760X', 'Zhang|Lihui|L|', 'Sun|Yadong|Y|', 'Chen|Daoxiong|D|', 'Qin|Guijun|G|0000-0002-2503-7534', 'Lu|Weiping|W|0000-0003-0737-1958', 'Guo|Yushan|Y|', 'Zhang|Yuwei|Y|', 'Liu|Haiyan|H|', 'Zhang|Tao|T|', 'Zou|Jianjun|J|']
D001786:Blood Glucose D019086:Bridged Bicyclo Compounds, Heterocyclic D003924:Diabetes Mellitus, Type 2 D004032:Diet D004311:Double-Blind Method D004359:Drug Therapy, Combination D006442:Glycated Hemoglobin A D006801:Humans D007004:Hypoglycemic Agents D016896:Treatment Outcome
henagliflozin type 2 diabetes sodium-glucose co-transporter-2 inhibitor