Effects of luseogliflozin, a sodium-glucose co-transporter 2 inhibitor, on 24-h glucose variability assessed by continuous glucose monitoring in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, crossover study

Abstract

The aim of the present study was to determine the effects of luseogliflozin on 24-h glucose levels, assessed by continuous glucose monitoring, and on pharmacodynamic variables measured throughout the day. In this double-blind, placebo-controlled, crossover study, 37 patients with type 2 diabetes mellitus inadequately controlled with diet and exercise were randomized into two groups. Patients in each group first received luseogliflozin then placebo for 7 days each, or vice versa. After 7 days of treatment, the mean 24-h glucose level was significantly lower with luseogliflozin than with placebo [mean (95% confidence interval) 145.9 (134.4-157.5) mg/dl vs 168.5 (156.9-180.0) mg/dl; p < 0.001]. The proportion of time spent with glucose levels ≥70 to ≤180 mg/dl was significantly greater with luseogliflozin than with placebo [median (interquartile range) 83.2 (67.7-96.5)% vs 71.9 (46.9-83.3)%; p < 0.001] without inducing hypoglycaemia. The decrease in glucose levels was accompanied by reductions in serum insulin levels throughout the day.

Keywords: 24-h glucose variability; SGLT2 inhibitor; continuous glucose monitoring; luseogliflozin; type 2 diabetes.

Figure 1

(A) Twenty‐four‐hour plasma glucose levels, as measured by continuous glucose monitoring after 7 days of once‐daily administration of 2.5 mg luseogliflozin or placebo. Values are means ± standard deviation (s.d.). Glucose: 1 mg/dl = 0.0556 mmol/l. (B) Twenty‐four‐hour serum insulin levels after 7 days of once‐daily administration of 2.5 mg luseogliflozin or placebo. Values are means ± s.d. *p < 0.05 for luseogliflozin versus placebo. Insulin: 1 µU/ml = 6.945 pmol/l. (C) Twenty‐four‐hour plasma glucagon levels after 7 days of once‐daily administration of 2.5 mg luseogliflozin or placebo. Values are means ± s.d. *p < 0.05 for luseogliflozin versus placebo. Glucagon: 1 pg/ml = 1 ng/l. (D) Cumulative urinary glucose excretion after 7 days of once‐daily administration of 2.5 mg luseogliflozin or placebo. Values are means ± s.d. *p < 0.05 for luseogliflozin versus placebo.