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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Dapagliflozin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01165268

MB102-066

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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%