Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.

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

Details

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

Criteria

Inclusion criteria for T2DM

• Diagnosis of T2DM

• Must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin

• Subjects taking metformin, and/or sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration

• Must have a fasting plasma glucose concentration ≤ 200 mg/dl, and HbA1C ≤ 10%

Inclusion criteria for healthy subjects:

• Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)

Inclusion criteria for all subjects:

• Subjects with (eGFR ≥ 60 and ≤ 160 mL/min/1.73m² and urinary albumin excretion < 300 mg/g creatinine)

• Body Mass Index (BMI) of 18 to 38 kg/m²

• Men and women, ages 18 to 65 years, inclusive

Exclusion criteria for all subjects:

• Subjects with Type 1 Diabetes or uncontrolled Type 2 Diabetes Mellitus

• Subjects with T2DM with fasting plasma glucose > 200 mg/dL, healthy subjects with fasting plasma glucose > 105 mg/dL

• Subjects with T2DM with HbA1C > 10.0%, healthy subjects with HbA1C > 6.8%