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

This study has been completed.
Sponsor:
Collaborator:
Astra Zeneca, Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00976495
First received: September 11, 2009
Last updated: January 18, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Dapagliflozin
Drug: Placebo
Drug: Hydrochlorothiazide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF]) [ Time Frame: From Baseline to Week 12 ]
    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.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 12 ]
    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.

  • 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 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.

  • Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 12 ]
    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.


Enrollment: 154
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapagliflozin Drug: Dapagliflozin
Tablets, Oral, 10 mg, once daily, 12 weeks
Other Name: BMS-512148
Drug: Placebo
Tablets, Oral, 0 mg, once daily, 12 weeks
Active Comparator: Hydrochlorothiazide Drug: Hydrochlorothiazide
Tablets, Oral, 25 mg, once daily, 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976495

Locations
United States, California
Advanced Clinical Res Inst
Anaheim, California, United States, 92801
Torrance Clinical Research
Lomita, California, United States, 90717
United States, Florida
Elite Research Institute
Miami, Florida, United States, 33169
Compass Research, Llc
Orlando, Florida, United States, 32806
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Michigan
University Of Michigan
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Prism Research
St. Paul, Minnesota, United States, 55114
United States, Rhode Island
Memorial Hospital Of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, Wisconsin
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, United States, 53295
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
Local Institution
Laval, Quebec, Canada, H7T 2P5
Netherlands
Local Institution
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
AstraZeneca
Astra Zeneca, Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00976495     History of Changes
Other Study ID Numbers: MB102-035
EUDRACT #: 2009-010221-39
Study First Received: September 11, 2009
Results First Received: September 30, 2016
Last Updated: January 18, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 27, 2017