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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Dapagliflozin (Drug); Dapagliflozin (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The change in glycosylated hemoglobin (A1C)

Secondary outcome:

The change in estimated glomerular filtration rate (marker of kidney function)

The change in estimated creatinine clearance (marker of kidney function)

The change in fasting plasma glucose

The change in body weight

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Local Institution, Buenos Aires C1012AAR, Argentina

Local Institution, Buenos Aires C1408INH, Argentina

Local Institution, Cordoba 5000, Argentina

Local Institution, Cordoba X5006CBI, Argentina

Local Institution, Salta A4406CLA, Argentina

Local Institution, Copenhagen Nv 2400, Denmark

Local Institution, Gentofte 2820, Denmark

Local Institution, Hvidovre 2650, Denmark

Local Institution, Besancon Cedex 25030, France

Local Institution, Brest Cedex 29609, France

Local Institution, Paris Cedex 10 75475, France

Local Institution, Paris 75877, France

Local Institution, Poitiers Cedex 86021, France

Local Institution, Bangalore 560 052, India

Local Institution, Bangalore 560034, India

Local Institution, Chennai 600029, India

Local Institution, Pune, Maharashtra 411011, India

Local Institution, Rajasthan 302 001, India

Local Institution, Chieri 10023, Italy

Local Institution, Chieti Scalo 66013, Italy

Local Institution, Modena 41100, Italy

Local Institution, Padova 35128, Italy

Local Institution, Perugia 06126, Italy

Local Institution, Pisa 56126, Italy

Local Institution, Roma 00189, Italy

Local Institution, Siena 53100, Italy

Local Institution, Durango 34075, Mexico

Local Institution, Arequipa, Peru

Local Institution, Lima 18, Peru

Local Institution, Lima LIMA 13, Peru

Local Institution, Caguas 00725, Puerto Rico

Local Institution, San Juan 00909, Puerto Rico

Local Institution, Singapore 119074, Singapore

Local Institution, Barcelona 08036, Spain

Local Institution, San Sebastian De Los 28702, Spain

Local Institution, Vizcaya 48903, Spain

Local Institution, Calgary, Alberta T3B 0M3, Canada

Vista Medical Research, Inc., Mesa, Arizona 85206, United States

Local Institution, Capital Federal, Buenos Aires C1405BCJ, Argentina

Local Institution, Mar Del Plata, Buenos Aires 7600, Argentina

Local Institution, Zarate, Buenos Aires 2800, Argentina

Valley Research, Fresno, California 93720, United States

Marin Endocrine Care & Research, Inc., Greenbrae, California 94904, United States

Office Of Richard Cherlin, Md, Los Gatos, California 95032, United States

Diabetes Medical Center Of California, Northridge, California 91325, United States

Apex Research Of Riverside, Riverside, California 92505, United States

La Biomed At Harbor Ucla Med Ctr., Torrance, California 90502, United States

Endocrine Associates Of The Rockies, Denver, Colorado 80220, United States

Local Institution, Df, Distrito Federal 01120, Mexico

Local Institution, Df, Distrito Federal 06700, Mexico

Local Institution, Df, Distrito Federal 11800, Mexico

Panhandle Family Care Associates, Marianna, Florida 32446, United States

Genesis Clinical Research, Tampa, Florida 33614, United States

Endocrine Research Solutions, Inc., Roswell, Georgia 30076, United States

Local Institution, Celaya, Guanajuato 38000, Mexico

Local Institution, Guadalajara, Jalisco 44670, Mexico

Local Institution, Cercado De Lima, Lima 1, Peru

Local Institution, Indore, Madhya Pradesh 452001, India

Local Institution, Pune, Maharashtra 411 004, India

Local Institution, Winnipeg, Manitoba R3E 3P4, Canada

Twin Cities Clinical Research, Brooklyn Center, Minnesota 55430, United States

Kcva Medical Center Research Svc (151), Kansas City, Missouri 64128, United States

Va Nebraska-Western Iowa Health Care System (Nwihcs), Omaha, Nebraska 68105, United States

University Of Medicine And Dentistry Of New Jersey, Voorhees, New Jersey 08043, United States

Local Institution, Camperdown, New South Wales 2050, Australia

Local Institution, St Leonards, New South Wales 2065, Australia

Local Institution, Woollongong, New South Wales 2500, Australia

Winthrop University Hospital, Mineola, New York 11501, United States

Slocum-Dickson Medical Group, Pllc, New Hartford, New York 13413, United States

Local Institution, Monterrey, Nuevo Leon 64460, Mexico

Community Health Care Of Manchester, Akron, Ohio 44319, United States

Center For Thyroid Diseases And Endocrinology, Beachwood, Ohio 44122, United States

Physician Research, Inc., Zanesville, Ohio 43701, United States

Univ Of Oklahoma Health Science Center, Oklahoma City, Oklahoma 73104, United States

Local Institution, Barrie, Ontario L4M 7G1, Canada

Local Institution, Thornhill, Ontario L4J 8L7, Canada

Local Institution, Toronto, Ontario M4N 3M5, Canada

Local Institution, Toronto, Ontario M4R 2G4, Canada

Rogue Valley Clinical Research, Medford, Oregon 97504, United States

Drexel University College Of Medicine, Philadelphia, Pennsylvania 19102, United States

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States

Local Institution, Gatineau, Quebec J8V 2P5, Canada

Local Institution, Laval, Quebec H7T 2P5, Canada

Local Institution, Sherbrooke, Quebec J1G 5K2, Canada

Local Institution, Regina, Saskatchewan S4P 0W5, Canada

Low Country Internal Medicine Of Sc, Pa, Charleston, South Carolina 29406, United States

Carolina Health Specialists, Myrtle Beach, South Carolina 29572, United States

Palmetto Clinical Research, Summerville, South Carolina 29485, United States

Local Institution, Launceston, Tasmania 7250, Australia

Research Institute Of Dallas, Dallas, Texas 75231, United States

Westbury Medical Clinic P.A., Houston, Texas 77005, United States

The Strelitz Diabetes Center, Norfolk, Virginia 23510, United States

Capital Clinical Research Center, Olympia, Washington 98502, United States

Cedar Research Llc, Tacoma, Washington 98405, United States

Aurora Advanced Healthcare, Milwaukee, Wisconsin 53209, United States

Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin 53295, United States

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: June 2008
Last updated: March 20, 2015

Page last updated: August 23, 2015

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