NCT02452632

A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-group, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Astellas Pharma Korea, Inc. · Industry
• Sex: All
• Age: 19 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in combination with metformin and sitagliptin against placebo in combination with metformin and sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin and sitagliptin.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ASP1941	oral
DRUG	Placebo	oral

Timeline

• Start date: 2015-06-22
• Primary completion: 2017-01-05
• Completion: 2017-01-05
• First posted: 2015-05-22
• Last updated: 2024-11-12

Locations

22 sites across 1 country: South Korea