Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity

Inclusion Criteria:

• Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0 and ≤ 10.0% at the enrollment visit
• Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment
• C-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
• BMI ≤ 45.0 kg/m2

Exclusion Criteria:

• Urine albumin to creatinine ratio (UACR) > 1,800 mg/g (203.4 mg/mmol/Cr)
• Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN)
• Alanine aminotransferase (ALT) > 3X ULN
• Serum Total Bilirubin > 2 mg/dL (34.2 μmol/l)
• Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases