A Phase 1 Study to Investigate the Mechanism of Action of Ipragliflozin

Status Completed

Clinical Trial Summary

In this study the effect of ipragliflozin on glucose homeostasis in healthy subjects and T2DM subjects, and the effect of exposure of ipragliflozin on urinary glucose excretion and plasma glucose in T2DM subjects will be investigated.

Clinical Trial Description

This study will consist of 2 parts. In Part A the effect of ipragliflozin on the glucose homeostasis will be investigated and in Part B we will investigate the effect of exposure of ipragliflozin on UGE and plasma glucose levels.

Part A

This part will be a randomized, double-blind, placebo-controlled, 2-

period, 2 treatment crossover design in healthy subjects and in T2DM

subjects who are drug naïve or washed out for metformin prior to

admission to the clinical site.

Part B

This part will be an open-label, randomized, 2-period, 2 treatment

crossover design in T2DM subjects stratified by baseline HbA1c

levels (6.0-6.9%, 7.0-7.9%, 8.0-8.9% or 9.0-9.9%). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01611363
Study type	Interventional
Source	Astellas Pharma Inc
Contact
Status	Completed
Phase	Phase 1
Start date	October 27, 2011
Completion date	February 3, 2012

View Details

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