Overview

A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients

Status:
Completed
Trial end date:
2011-11-28
Target enrollment:
0
Participant gender:
All
Summary
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin in patients with diabetes mellitus.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Ipragliflozin
Metformin
Criteria
Inclusion Criteria:

- Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 weeks

- HbA1c value between 7.0 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

- Estimated GFR < 60ml/min/1.73m2

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

- Dysuria and/or urinary tract infection, genital infection

- Significant renal, hepatic or cardiovascular diseases

- Severe gastrointestinal diseases