NCT01611363

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

An Exploratory Study to Investigate the Effects of Ipragliflozin (ASP1941) on Glucose Homeostasis and Urinary Glucose Excretion in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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%).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ASP1941	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2011-10-27
• Primary completion: 2012-02-03
• Completion: 2012-02-03
• First posted: 2012-06-05
• Last updated: 2017-08-22

Locations

1 site across 1 country: Germany