Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
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
2 other identifiers
interventional
154
3 countries
12
Brief Summary
The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Oct 2009
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
March 8, 2017
CompletedMarch 8, 2017
January 1, 2017
1.1 years
September 11, 2009
September 30, 2016
January 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From Baseline to Week 12
Secondary Outcomes (3)
Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
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])
From Baseline to Week 12
Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
From Baseline to Week 12
Study Arms (2)
Dapagliflozin
EXPERIMENTALHydrochlorothiazide
ACTIVE COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Astra Zeneca, Bristol-Myers Squibbcollaborator
Study Sites (12)
Advanced Clinical Res Inst
Anaheim, California, 92801, United States
Torrance Clinical Research
Lomita, California, 90717, United States
Elite Research Institute
Miami, Florida, 33169, United States
Compass Research, Llc
Orlando, Florida, 32806, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
University Of Michigan
Ann Arbor, Michigan, 48106, United States
Prism Research
Saint Paul, Minnesota, 55114, United States
Memorial Hospital Of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, 53295, United States
Local Institution
Toronto, Ontario, M4G 3E8, Canada
Local Institution
Laval, Quebec, H7T 2P5, Canada
Local Institution
Groningen, 9713 GZ, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anna Maria Langkilde
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 14, 2009
Study Start
October 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
March 8, 2017
Results First Posted
March 8, 2017
Record last verified: 2017-01