NCT01054092

A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients

Long-term Study of ASP1941 - A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.

Detailed description

Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. 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

Timeline

• Start date: 2010-01-14
• Primary completion: 2011-07-22
• Completion: 2011-07-22
• First posted: 2010-01-22
• Last updated: 2025-05-30

Locations

7 sites across 1 country: Japan