NCT01242202

A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients

Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With an α-Glucosidase Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With an α-Glucosidase Inhibitor Alone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus.

Detailed description

This is a 52-week multi-center study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on an α-Glucosidase Inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ipragliflozin	oral
DRUG	alpha glucosidase inhibitor	oral

Timeline

• Start date: 2010-10-21
• Primary completion: 2012-05-25
• Completion: 2012-05-25
• First posted: 2010-11-16
• Last updated: 2025-05-30

Locations

6 sites across 1 country: Japan