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Clinical Trial Details

Trial ID: L2487
Source ID: NCT00663260
Associated Drug: Dapagliflozin
Title: Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00663260/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Dapagliflozin|DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: Primary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF], 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., From Baseline to Week 24 | Secondary: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]), 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, From Baseline to Week 24|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]), 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., From Baseline to Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 631
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-06
Completion Date: 2011-06
Results First Posted: 2017-02-10
Last Update Posted: 2017-02-10
Locations: Vista Medical Research, Inc., Mesa, Arizona, 85206, United States|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|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|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|Winthrop University Hospital, Mineola, New York, 11501, United States|Slocum-Dickson Medical Group, Pllc, New Hartford, New York, 13413, United States|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|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|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|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|Local Institution, Capital Federal, Buenos Aires, C1405BCJ, Argentina|Local Institution, Mar Del Plata, Buenos Aires, 7600, Argentina|Local Institution, Zarate, Buenos Aires, 2800, Argentina|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, Camperdown, New South Wales, 2050, Australia|Local Institution, St Leonards, New South Wales, 2065, Australia|Local Institution, Woollongong, New South Wales, 2500, Australia|Local Institution, Launceston, Tasmania, 7250, Australia|Local Institution, Calgary, Alberta, T3B 0M3, Canada|Local Institution, Winnipeg, Manitoba, R3E 3P4, Canada|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|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|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, Indore, Madhya Pradesh, 452001, India|Local Institution, Pune, Maharashtra, 411 004, India|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, Df, Distrito Federal, 01120, Mexico|Local Institution, Df, Distrito Federal, 06700, Mexico|Local Institution, Df, Distrito Federal, 11800, Mexico|Local Institution, Celaya, Guanajuato, 38000, Mexico|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Durango, 34075, Mexico|Local Institution, Cercado De Lima, Lima, 1, Peru|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
URL: https://clinicaltrials.gov/show/NCT00663260

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details