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

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Dapagliflozin

Drug: Placebo

Drug: Hydrochlorothiazide

Study type

Interventional

Funder types

Other

Industry

Identifiers

EUDRACT #: 2009-010221-39

MB102-035

Details and patient eligibility

About

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

Enrollment

154 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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