Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency
NCT ID: NCT00616811
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2008-01-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vildagliptin
vildagliptin
Sitagliptin
Sitagliptin
Interventions
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vildagliptin
Sitagliptin
Eligibility Criteria
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Inclusion Criteria
* Severe Renal Impairment
Exclusion Criteria
* Patients undergoing any method of dialysis
* Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides
18 Years
85 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals Corporation
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of South Alabama Medical Center
Mobile, Alabama, United States
Anasazi Internal Medicine
Phoenix, Arizona, United States
University of Arkanasas for Medical Sciences
Little Rock, Arkansas, United States
Office of William Zigrang
Burlingame, California, United States
John Muir Clinical Research
Concord, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Northern California Institute for Bone Health
Oakland, California, United States
Dr. Wei Feng
Pasadena, California, United States
Sierra Clinical Research - Orangevale
Roseville, California, United States
Denver Nephrology PC
Denver, Colorado, United States
Western Nephrology & Metabolic Bone Disease PC
Lakewood, Colorado, United States
Western Nephrology & Metabolic Bone Disease PC
Westminster, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Nephrology Associates of South Miami
Aventura, Florida, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
Center for Diabetes & Endocrine Care
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Osler Medical Clinical Research
Melbourne, Florida, United States
Tampa Bay Nephrology Associates
Tampa, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Emory Clinic
Atlanta, Georgia, United States
University of Hawaii
Honolulu, Hawaii, United States
Boise Kidney & Hypertension Institiute
Meridian, Idaho, United States
Iowa Diabetes & Endocrinology Research Center PLC
Des Moines, Iowa, United States
University of Iowa
Iowa City, Iowa, United States
Cray Diabetes Education Center
Kansas City, Kansas, United States
Cotton-O'Neil Diabetes & Endocrinology Center
Topeka, Kansas, United States
Dolby Research, LLC
Baton Rouge, Louisiana, United States
Metabolic Center of Louisiana
Baton Rouge, Louisiana, United States
Bruce Samuels LLC
Covington, Louisiana, United States
Crescent City Clinical Research Center
Metairie, Louisiana, United States
Egan Healthcare
Metairie, Louisiana, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, United States
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, United States
Joslin Diabetes Center at North Arundel Hospital
Glen Burnie, Maryland, United States
Biolab Research, LLC
Rockville, Maryland, United States
Genesys Integrated Group Practice, PC
Flint, Michigan, United States
Phillips Medical Services, PLLC
Jackson, Mississippi, United States
Mississippi Medical Research, LLC
Picayune, Mississippi, United States
Diabetes and Endocrinology Specialist, Inc
Chesterfield, Missouri, United States
Jefferson City Medical Group
Jefferson City, Missouri, United States
Arms, Dodge, Robinson, Wilber & Crouch, Inc.
Kansas City, Missouri, United States
Washington U School of Medicine
St Louis, Missouri, United States
Platte Valley Medical Group
Kearney, Nebraska, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
Creighton Nephrology
Omaha, Nebraska, United States
UMDNJ-Robert Wood Johnson
New Brunswick, New Jersey, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States
Downstate University of Brooklyn
Brooklyn, New York, United States
HRRG
Orchard Park, New York, United States
Mayo Clinic Rochester
Rochester, New York, United States
SUNY - Upstate Medical University
Syracuse, New York, United States
Meritcare Medical Group
Fargo, North Dakota, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Willamette Valley Clinical Studies
Eugene, Oregon, United States
Lehigh Valley Hospital-Dept. of Medicine Research
Allentown, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Renal Endocrine Associates, P. C.
Pittsburgh, Pennsylvania, United States
Aiken Center for Clinical Research
Aiken, South Carolina, United States
Medical U of South Carolina
Charleston, South Carolina, United States
SC Nephrology and Hyptertension Center, Inc.
Orangeburg, South Carolina, United States
Sumter Medical Specialists
Sumter, South Carolina, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, United States
Medical Nephrology Associates
Dyersburg, Tennessee, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Texas Tech University Health Sciences
El Paso, Texas, United States
Baylor Clinic (BCM 621)
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Allied Institute of Medicine
San Antonio, Texas, United States
Central Utah Clinic
American Fork, Utah, United States
Clinical Research and Consulting Center, LLC
Fairfax, Virginia, United States
Medical College of Virginia
Richmond, Virginia, United States
Medical College of Virginia
Richmond, Virginia, United States
Washington State University at Spokane
Spokane, Washington, United States
UW Health - West
Madison, Wisconsin, United States
Countries
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References
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Kothny W, Lukashevich V, Foley JE, Rendell MS, Schweizer A. Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment: a randomised clinical trial. Diabetologia. 2015 Sep;58(9):2020-6. doi: 10.1007/s00125-015-3655-z. Epub 2015 Jun 12.
Related Links
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Results for CLAF237A23138 from the Novartis Clinical Trials website
Other Identifiers
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CLAF237A23138
Identifier Type: -
Identifier Source: org_study_id