A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment

• Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening

• HbA1c of ≥6.5% and ≤10.5% at screening

Exclusion Criteria:

• Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus

• Past or current history of severe diabetic complications

• Patients requiring insulin therapy

• History of hereditary glucose-galactose malabsorption or primary renal glucosuria