A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2012-06-06
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Alogliptin; Dipeptidyl-Peptidase IV Inhibitors; Ipragliflozin; Saxagliptin; Sitagliptin Phosphate; Vildagliptin

Criteria

Inclusion Criteria:

• Type 2 diabetic patients receiving with DPP-4 inhibitor mono-therapy for at least 4 weeks

• HbA1c value between 6.5 and 9.5%

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

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