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