Status:
COMPLETED
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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%
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01165268
Start Date
August 1 2010
End Date
December 1 2010
Last Update
November 17 2016
Active Locations (1)
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1
Profil Institute For Clinical Research, Inc.
Chula Vista, California, United States, 91911