Efficacy and safety of ipragliflozin add-on therapy to insulin in Japanese patients with type 1 diabetes mellitus: A randomized, double-blind, phase 3 trial.

ABSTRACT:

Aim

To assess the efficacy and safety of once-daily ipragliflozin 50 mg versus placebo in Japanese people with type 1 diabetes mellitus (T1DM) inadequately controlled with insulin.

Materials and methods

We conducted a multicentre, double-blind, parallel-group, placebo-controlled phase 3 study. Participants (N = 175) were randomized (2:1) to receive once-daily ipragliflozin 50 mg (n = 115) or placebo (n = 60), combined with insulin, for 24 weeks. The primary endpoint was change in glycated haemoglobin (HbA1c); key secondary endpoints included change in insulin dose and body weight. Treatment-emergent adverse events (TEAEs) were evaluated.

Results

The ipragliflozin group demonstrated a significant decrease in HbA1c from baseline to end of treatment versus the placebo gr

SUBMITTER: Kaku K 

PROVIDER: S-EPMC6772182 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature