NCT01514838

A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

A Phase III, Double-Blind, Randomized, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.

Detailed description

This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the ASP1941 or the acarbose group. Subjects will take the study drug under the double-blind condition in the treatment period. After completion of the study drug administration, a follow-up period will be provided.

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ASP1941	oral
DRUG	acarbose	oral
DRUG	Placebo	oral, used only during placebo run-in period

Timeline

• Start date: 2012-04-23
• Primary completion: 2012-10-19
• Completion: 2012-10-19
• First posted: 2012-01-23
• Last updated: 2024-11-12

Locations

15 sites across 2 countries: South Korea, Taiwan