A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients

• Status: Completed
• Trial end date: 2010-11-06
• Target enrollment: 0
• Participant gender: All

Summary

This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin

Criteria

Inclusion Criteria:

• Type 2 diabetic patients for at least 12 weeks

• HbA1c value between 7.0 and 10.0%

• Body Mass Index (BMI) 20.0 - 45.0 kg/m2

• Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment

Exclusion Criteria:

• Type 1 diabetes mellitus patients

• Serum creatinine > upper limit of normal

• Proteinuria (albumin/creatinine ratio > 300mg/g)

• Dysuria and/or urinary tract infection, genital infection

• Significant renal, hepatic or cardiovascular diseases

• Severe gastrointestinal diseases