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Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00663260
First Posted: April 22, 2008
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: Dapagliflozin Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF] [ Time Frame: From Baseline to Week 24 ]
    HbA1c was measured as percent of hemoglobin by a central laboratory. 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. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period

  • Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.


Enrollment: 631
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dapagliflozin (10 mg) Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once Daily, 104 weeks
Other Name: BMS-512148
Active Comparator: Dapagliflozin (5 mg) Drug: Dapagliflozin
Tablets, Oral, 5 mg, Once Daily, 104 weeks
Other Name: BMS-512148
Placebo Comparator: Placebo Drug: Placebo
Tablets, Oral, 0 mg, Once Daily, 104 weeks

Detailed Description:
All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
  • Clinical diagnosis of moderate renal impairment

Exclusion Criteria:

  • AST and /or ALT > 3.0 times the upper limit of normal
  • Serum total bilirubin > 1.5 times ULN
  • Symptoms of severely uncontrolled diabetes
  • Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663260


  Hide Study Locations
Locations
United States, Arizona
Vista Medical Research, Inc.
Mesa, Arizona, United States, 85206
United States, California
Valley Research
Fresno, California, United States, 93720
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States, 94904
Office Of Richard Cherlin, Md
Los Gatos, California, United States, 95032
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Apex Research Of Riverside
Riverside, California, United States, 92505
La Biomed At Harbor Ucla Med Ctr.
Torrance, California, United States, 90502
United States, Colorado
Endocrine Associates Of The Rockies
Denver, Colorado, United States, 80220
United States, Florida
Panhandle Family Care Associates
Marianna, Florida, United States, 32446
Genesis Clinical Research
Tampa, Florida, United States, 33614
United States, Georgia
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States, 30076
United States, Minnesota
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States, 55430
United States, Missouri
Kcva Medical Center Research Svc (151)
Kansas City, Missouri, United States, 64128
United States, Nebraska
Va Nebraska-Western Iowa Health Care System (Nwihcs)
Omaha, Nebraska, United States, 68105
United States, New Jersey
University Of Medicine And Dentistry Of New Jersey
Voorhees, New Jersey, United States, 08043
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Slocum-Dickson Medical Group, Pllc
New Hartford, New York, United States, 13413
United States, Ohio
Community Health Care Of Manchester
Akron, Ohio, United States, 44319
Center For Thyroid Diseases And Endocrinology
Beachwood, Ohio, United States, 44122
Physician Research, Inc.
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Univ Of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Rogue Valley Clinical Research
Medford, Oregon, United States, 97504
United States, Pennsylvania
Drexel University College Of Medicine
Philadelphia, Pennsylvania, United States, 19102
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Low Country Internal Medicine Of Sc, Pa
Charleston, South Carolina, United States, 29406
Carolina Health Specialists
Myrtle Beach, South Carolina, United States, 29572
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
United States, Texas
Research Institute Of Dallas
Dallas, Texas, United States, 75231
Westbury Medical Clinic P.A.
Houston, Texas, United States, 77005
United States, Virginia
The Strelitz Diabetes Center
Norfolk, Virginia, United States, 23510
United States, Washington
Capital Clinical Research Center
Olympia, Washington, United States, 98502
Cedar Research Llc
Tacoma, Washington, United States, 98405
United States, Wisconsin
Aurora Advanced Healthcare
Milwaukee, Wisconsin, United States, 53209
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, United States, 53295
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, C1405BCJ
Local Institution
Mar Del Plata, Buenos Aires, Argentina, 7600
Local Institution
Zarate, Buenos Aires, Argentina, 2800
Local Institution
Buenos Aires, Argentina, C1012AAR
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Buenos Aires, Argentina, C1408INH
Local Institution
Cordoba, Argentina, 5000
Local Institution
Cordoba, Argentina, X5006CBI
Local Institution
Salta, Argentina, A4406CLA
Australia, New South Wales
Local Institution
Camperdown, New South Wales, Australia, 2050
Local Institution
St Leonards, New South Wales, Australia, 2065
Local Institution
Woollongong, New South Wales, Australia, 2500
Australia, Tasmania
Local Institution
Launceston, Tasmania, Australia, 7250
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T3B 0M3
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Local Institution
Barrie, Ontario, Canada, L4M 7G1
Local Institution
Thornhill, Ontario, Canada, L4J 8L7
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Toronto, Ontario, Canada, M4N 3M5
Local Institution
Toronto, Ontario, Canada, M4R 2G4
Canada, Quebec
Local Institution
Gatineau, Quebec, Canada, J8V 2P5
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Laval, Quebec, Canada, H7T 2P5
Local Institution
Sherbrooke, Quebec, Canada, J1G 5K2
Canada, Saskatchewan
Local Institution
Regina, Saskatchewan, Canada, S4P 0W5
Denmark
Local Institution
Copenhagen Nv, Denmark, 2400
Local Institution
Gentofte, Denmark, 2820
Local Institution
Hvidovre, Denmark, 2650
France
Local Institution
Besancon Cedex, France, 25030
Local Institution
Brest Cedex, France, 29609
Local Institution
Paris Cedex 10, France, 75475
Local Institution
Paris, France, 75877
Local Institution
Poitiers Cedex, France, 86021
India
Local Institution
Indore, Madhya Pradesh, India, 452001
Local Institution
Pune, Maharashtra, India, 411 004
Local Institution
Bangalore, India, 560 052
Local Institution
Bangalore, India, 560034
Local Institution
Chennai, India, 600029
Local Institution
Pune, Maharashtra, India, 411011
Local Institution
Rajasthan, India, 302 001
Italy
Local Institution
Chieri, Italy, 10023
Local Institution
Chieti Scalo, Italy, 66013
Local Institution
Modena, Italy, 41100
Local Institution
Padova, Italy, 35128
Local Institution
Perugia, Italy, 06126
Local Institution
Pisa, Italy, 56126
Local Institution
Roma, Italy, 00189
Local Institution
Siena, Italy, 53100
Mexico
Local Institution
Df, Distrito Federal, Mexico, 01120
Local Institution
Df, Distrito Federal, Mexico, 06700
Local Institution
Df, Distrito Federal, Mexico, 11800
Local Institution
Celaya, Guanajuato, Mexico, 38000
Local Institution
Guadalajara, Jalisco, Mexico, 44670
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Durango, Mexico, 34075
Peru
Local Institution
Cercado De Lima, Lima, Peru, 1
Local Institution
Arequipa, Peru
Local Institution
Lima, Peru, 18
Local Institution
Lima, Peru, LIMA 13
Puerto Rico
Local Institution
Caguas, Puerto Rico, 00725
Local Institution
San Juan, Puerto Rico, 00909
Singapore
Local Institution
Singapore, Singapore, 119074
Spain
Local Institution
Barcelona, Spain, 08036
Local Institution
San Sebastian De Los, Spain, 28702
Local Institution
Vizcaya, Spain, 48903
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00663260     History of Changes
Other Study ID Numbers: MB102-029
First Submitted: April 18, 2008
First Posted: April 22, 2008
Results First Submitted: September 28, 2016
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases