Renal Mechanism of Action/Splay vs. TmG

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

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