Clinical trial NCT00976495: Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Astra Zeneca, Bristol-Myers Squibb
First posted: 2009-09-14
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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

Primary outcomes:
measure: Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 12
measure: Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 12
measure: Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 12
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Res Inst
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research
state: California
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: Orlando
country: United States
facility: Compass Research, Llc
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
city: St. Paul
country: United States
facility: Prism Research
state: Minnesota
city: Pawtucket
country: United States
facility: Memorial Hospital Of Rhode Island
state: Rhode Island
city: Milwaukee
country: United States
facility: Zablocki Veterans Affairs Medical Center
state: Wisconsin
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Laval
country: Canada
facility: Local Institution
state: Quebec
city: Groningen
country: Netherlands
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: