NCT01117584

A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus

Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12-Week Treatment With ASP1941 in Combination With Metformin in Patients With Type 2Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy, safety and tolerability of a 12-week treatment of 4 doses of ASP1941 compared to placebo in combination with metformin in adult patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin alone.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ipragliflozin	oral tablet
DRUG	Placebo	oral tablet
DRUG	Metformin	oral tablet

Timeline

• Start date: 2010-04-06
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-05-05
• Last updated: 2025-05-22

Locations

44 sites across 6 countries: United States, Hungary, Italy, Poland, Romania, United Kingdom