Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-12-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus

• Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%

• C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)

• Body Mass Index ≤ 45 kg/m²

• Must be able to perform self monitoring of blood glucose

Exclusion Criteria:

• aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)

• Serum Total bilirubin >2 mg/dL (34.2 µmol/L)

• Creatinine kinase >3* ULN

• Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects

• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases