Efficacy and safety of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, phase 3 study

Abstract

Objective: Luseogliflozin -a novel, orally bioavailable, 1-thio-D-glucitol derivative and a selective sodium glucose cotransporter 2 inhibitor -has shown efficacy and tolerability in previous phase 2 studies. This phase 3, randomized, double-blind, placebo-controlled, comparative study aimed to confirm the superiority of 24 week luseogliflozin 2.5 mg monotherapy over placebo in reducing hemoglobin A1c (HbA1c) levels in Japanese patients with type 2 diabetes mellitus (T2DM). Methods:Patients with HbA1c levels of 6.9%-10.5% were randomized to receive luseogliflozin 2.5 mg or placebo once daily for 24 weeks (n ¼ 79 in each group). The primary endpoint was change from baseline in HbA1c at end of treatment. Secondary endpoints included change from baseline in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) following a meal tolerance test, body weight, and abdominal circumference. Safety assessments included adverse events (AEs), clinical laboratory tests, and vital signs.

Fifty-two-week long-term clinical study of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise

“…*P< 0.001 (compared to baseline using the one-sample t-test). CI, confidence interval; FPG, fasting plasma glucose; HbA1c, hemoglobin A1c; SD, standard deviation ies [6,7,11]. It was also comparable to that observed in a 52-week study of sitagliptin (1.7%), a DPP-4 inhibitor known for its low incidence of hypoglycemia when administered as monotherapy [12].…”

“…Our previous study showed that luseogliflozin significantly reduced body weight at Week 24 [7]. Since the present study revealed that the weight reduction could be maintained for longer than 24 weeks, luseogliflozin may be more beneficial for the long-term management of patients with type 2 diabetes mellitus where weight gain is undesirable.…”

“…In addition, efficacy and safety of the drug given as monotherapy for up to 24 weeks compared to placebo was confirmed [7].…”

“…In addition, no patients experienced ketoacidosis. Further, previous studies of luseogliflozin showed a post-meal rapid decrease in fasting ketone bodies [6,7]. Given that luseogliflozin will be administered to patients comprising various metabolic types in clinical practice, further investigation is needed.…”

Changes in heart rate in patients with type 2 diabetes mellitus after treatment with luseogliflozin: Subanalysis of placebo‐controlled, double‐blind clinical trials

“…These studies are registered at the Japan Pharmaceutical Information Center (identifier: JapicCTI‐090908, JapicCTI‐101191 and JapicCTI‐111661)2, 3, 4. The major inclusion criteria were as follows: Japanese patients with type 2 diabetes mellitus receiving diet and exercise therapy alone, age ≥20 years and with glycated hemoglobin levels ≥6.9% to ≤10.5%.…”