A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.

• Status: Completed
• Trial end date: 2009-03-06
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin

Criteria

Inclusion Criteria:

• Established diagnosis of type 2 diabetes mellitus

• HbA1c value between 7.0 and 10.0%

• Body mass index between 20 and 45 kg/m2

Exclusion Criteria:

• Established diagnosis of type 1 diabetes mellitus

• Serum creatinine > upper limit of normal range

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

• Urinary tract infection

• Severe uncontrolled Hypertension

• Significant renal, hepatic or cardiovascular disease

• HIV Positive

• History of drug or alcohol abuse/dependency