Renal Mechanism of Action/Splay vs. TmG

Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus

Inclusion Criteria:

• Male and female subjects
• Age 18 to 65 years
• BMI 18 to 35 kg/m2
• Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin
• No evidence of impaired renal function

Exclusion Criteria:

• Unwilling or unable to use an acceptable method of birth control
• Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B
• Exposure to insulin
• Use of exclusionary concomitant medications
• Evidence of significant kidney disease or any other significant medical or psychiatric disorder