Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.

Key facts

Study ID

NCT00976495

Run by

AstraZeneca

People needed

154

Starts

2009-10-01

Expected to finish

2010-11-01

Last updated by the study team

2017-03-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Clinical Res Inst — Anaheim, California, United States
• Torrance Clinical Research — Lomita, California, United States
• Elite Research Institute — Miami, Florida, United States
• Compass Research, Llc — Orlando, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• University Of Michigan — Ann Arbor, Michigan, United States
• Prism Research — Saint Paul, Minnesota, United States
• Memorial Hospital Of Rhode Island — Pawtucket, Rhode Island, United States
• Zablocki Veterans Affairs Medical Center — Milwaukee, Wisconsin, United States
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Laval, Quebec, Canada
• Local Institution — Groningen, Netherlands

Full record on ClinicalTrials.gov

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