A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2009-03-14
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients 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

• Fasting serum C-peptide level > 0.6 ng/mL

• HbA1c between 7.0 and 10.0%

• Body Mass Index between 20 and 45 kg/m2

Exclusion Criteria:

• Serum creatinine > upper limit of normal

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

• Dysuria and/or urinary tract infection

• Significant renal, hepatic or cardiovascular diseases

• Ketosis

• Hypertension

• Severe gastrointestinal diseases