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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic and Blood Pressure (BP) Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976495
• Other study ID #: MB102-035
• Secondary ID: EUDRACT #: 2009-
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2009
• Last updated: March 24, 2015
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 10 mg, once daily, 12 weeks
• Placebo
Tablets, Oral, 0 mg, once daily, 12 weeks
• Hydrochlorothiazide
Tablets, Oral, 25 mg, once daily, 12 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular Filtration Rate as measured by plasma clearance of non-radioactive iohexol		After 12 weeks of double-blind oral administration	Yes
Secondary	Ambulatory blood pressure. Red cell mass measured by dilution of radioisotopically tagged erythrocytes & plasma volume (PV) measured by dilution of radioisotopically labeled human serum albumin. RCM&PV measured in subset of subjects (part of a substudy)		After 12 weeks of double-blind oral administration	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form