Clinical pharmacology study of ipragliflozin in Japanese patients with type 1 diabetes mellitus: A phase 2, randomized, placebo-controlled trial.

ABSTRACT:

Aim

To evaluate the pharmacodynamics, pharmacokinetics, and safety of the novel oral sodium-glucose co-transporter-2 inhibitor, ipragliflozin, in Japanese patients with type 1 diabetes mellitus.

Materials and methods

We conducted a multicentre, double-blind, placebo-controlled, parallel-group study. Patients were randomized to receive 25, 50, or 100 mg/day ipragliflozin or placebo for 2 weeks. Key pharmacokinetic endpoints included area under the concentration-time curve 24 hours postdose (AUC_24h ), maximum plasma concentration (C_max ), and renal clearance. Key pharmacodynamic endpoints included 24-hour urinary glucose excretion, mean plasma glucose AUC_0-24h , and mean renal glucose clearance. Changes in total, basal, and bolus insulin dosage

SUBMITTER: Kaku K 

PROVIDER: S-EPMC6594083 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature