Status:
COMPLETED
Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Astra Zeneca, Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.
Eligibility Criteria
Inclusion
- Type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 6.6 and ≤ 9.5%
- Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the enrollment visit
- Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and \< 165 mmHg, AND/OR diastolic BP (DBP) ≥ 80 and \< 105 mmHg
- C-peptide ≥ 0.8 ng/mL
- Estimated GFR by the Modification of Diet in Renal Disease (MDRD) formula \> 60 mL/min/1.73m² and \< 150 mL/min/1.73m²
- Urine albumin:creatinine ratio (UACR) \< 300 mg/g
- BMI ≤ 45.0 kg/m2
Exclusion
- Administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either ACEI or ARB), at any dose during the 12 weeks prior to the enrollment visit
- History of adverse reaction to radio-contrast dye
- Allergy or contraindication to use of thiazide diuretics
- Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN)
- Alanine aminotransferase (ALT) \> 3X ULN
- Serum Total Bilirubin \> 1.5X ULN
- Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00976495
Start Date
October 1 2009
End Date
November 1 2010
Last Update
March 8 2017
Active Locations (12)
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1
Advanced Clinical Res Inst
Anaheim, California, United States, 92801
2
Torrance Clinical Research
Lomita, California, United States, 90717
3
Elite Research Institute
Miami, Florida, United States, 33169
4
Compass Research, Llc
Orlando, Florida, United States, 32806