AIMS: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).
MATERIALS AND METHODS: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 HbA1c ≥7.0% and ≤10.5% were randomized (1:1:1) to receive once-daily placebo, 25 mg or 50 mg janagliflozin. After 24 weeks, patients on placebo were switched and re-randomized (1:1) to 25 mg or 50 mg janagliflozin, whereas patients on janagliflozin maintained the initial therapy. The primary endpoint was the change from baseline in HbA1c after 24 weeks.
RESULTS:At Week 24, the placebo-adjusted LS mean changes of HbA1c were -0.80% (95% CI -0.98% to -0.62%) and -0.88% (95% CI -1.06% to -0.70%), respectively (P <0.001 for both). Higher proportion of patients achieving HbA1c <7.0% with janagliflozin 25 mg and 50 mg compared with placebo (47.2%, 49.3%, and 23.5%, respectively). Both janagliflozin doses significantly decreased FPG, 2-h PPG, body weight, and SBP, as well as increased HDL-C and insulin sensitivity compared with placebo (P <0.05 for all). The trends in improvement of these variables were sustained during the 28-week extension period. Overall incidences of AEs were 67.8%, 71.5% and 60.7% with janagliflozin 25 mg, 50 mg and placebo, respectively. The incidence of UTIs and genital fungal infections was low. No severe hypoglycemia and ketoacidosis occurred.
CONCLUSIONS:Janagliflozin 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.
CLINICAL TRIAL REGISTRATION NO:NCT03811548 This article is protected by copyright. All rights reserved.