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

AstraZeneca154 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

154

Conditions

Type 2 Diabetes Mellitus

Interventions

DapagliflozinDRUG

Tablets, Oral, 10 mg, once daily, 12 weeks

PlaceboDRUG

Tablets, Oral, 0 mg, once daily, 12 weeks

HydrochlorothiazideDRUG

Tablets, Oral, 25 mg, once daily, 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (12)

Advanced Clinical Res Inst

Anaheim, California, United States

Torrance Clinical Research

Lomita, California, United States

Elite Research Institute

Miami, Florida, United States

Outcomes

Primary Outcomes

Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])

Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.

Time frame: From Baseline to Week 12

Secondary Outcomes

Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])

Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.

Time frame: From Baseline to Week 12

Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])

Time frame: From Baseline to Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.