Henagliflozin as add‐on therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin: A multicenter, randomized, double‐blind, placebo‐controlled, phase 3 trial

AIMS This study evaluated the efficacy and safety of henagliflozin in patients with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. MATERIAL AND METHODS This multicenter Phase 3 trial included a 24-week randomized, double-blind, placebo-controlled period, followed by a 28-week extension period. Patients with a hemoglobin A1c (HbA1c) of 7.0%-10.5% were randomized and treated with once-daily Placebo (n=161), Henagliflozin 5 mg (n=162), or Henagliflozin 10 mg (n=160). After 24 weeks, patients on placebo were switched to 5 or 10 mg henagliflozin for the additional 28-week treatment, and patients on henagliflozin during 24-week treatment period maintained the initial therapy. The primary endpoint was change in HbA1c from baseline to Week 24. RESULTS At Week 24, the least-squares mean HbA1c changes versus placebo from baseline were -0.76% and -0.80% for henagliflozin 5 mg and 10 mg (All P<.0001). Compared with the Placebo group, both doses of henagliflozin lowered fasting plasma glucose, 2-hour postprandial plasma glucose, body weight, blood pressure and increased the proportions of patients achieving HbA1c <7.0% at Week 24. The trends of these improvements could be sustained over additional 28 weeks. Slightly higher proportions of ketosis, urine ketone body present could be observed in patients treated with henagliflozin compared to placebo at Week 24. No diabetic ketoacidosis or episode of severe hypoglycemia was reported. CONCLUSIONS Henagliflozin 5 or 10 mg as add-on therapy to metformin provided a new therapeutic option for treatment of T2DM patients who have inadequate glycemic control with metformin alone, and was generally well tolerated. This article is protected by copyright. All rights reserved.