Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

Last updated: December 11, 2020
Sponsor: Novartis
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Kidney Disease

Nephropathy

Treatment

N/A

Clinical Study ID

NCT00770081
CLAF237A23138E1
  • Ages 18-85
  • All Genders

Study Summary

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 52 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Complete the core study and consent for extension

Exclusion

Exclusion Criteria:

  • Patient unable to comply with core study requirements

Study Design

Total Participants: 75
Study Start date:
September 01, 2008
Estimated Completion Date:
April 30, 2011

Connect with a study center

  • University of South Alabama Medical Center

    Mobile, Alabama 36617
    United States

    Site Not Available

  • Anasazi Internal Medicine

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Sonoran Health Specialists

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Mary K. Richards, MD. PA

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • University of Arkanasas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Burlingame, California 94010
    United States

    Site Not Available

  • John Muir Clinical Research

    Concord, California 94520
    United States

    Site Not Available

  • Academic Medical Research Institute

    Los Angeles, California 90022
    United States

    Site Not Available

  • UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Northern California Institute for Bone Health

    Oakland, California
    United States

    Site Not Available

  • Dr. Wei Feng

    Pasadena, California 91101
    United States

    Site Not Available

  • Sierra Clinical Research - Orangevale

    Roseville, California 95661
    United States

    Site Not Available

  • California Institute of Renal Research

    San Diego, California 92123
    United States

    Site Not Available

  • Denver Nephrology PC

    Denver, Colorado 80230
    United States

    Site Not Available

  • Western Nephrology & Metabolic Bone Disease PC

    Lakewood, Colorado 80214
    United States

    Site Not Available

  • Western Nephrology & Metabolic Bone Disease PC

    Westminster, Colorado 80031
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Nephrology Associates of South Miami

    Aventura, Florida 33180
    United States

    Site Not Available

  • University of Florida Shands Hospital

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Center for Diabetes & Endocrine Care

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Larry Levinson, D.O., PA

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Osler Medical Clinical Research

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Tampa Bay Nephrology Associates

    Tampa, Florida 33603
    United States

    Site Not Available

  • Atlanta Diabetes Associates

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Emory Clinic

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Hawaii

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Boise Kidney & Hypertension Institiute

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Iowa Diabetes & Endocrinology Research Center PLC

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Cray Diabetes Education Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Cotton-O'Neil Diabetes & Endocrinology Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Dolby Research, LLC

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Metabolic Center of Louisiana

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Bruce Samuels LLC

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Crescent City Clinical Research Center

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Egan Healthcare

    Metairie, Louisiana 70002
    United States

    Site Not Available

  • Arthritis and Diabetes Clinic

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • Northwest Louisiana Nephrology Research

    Shreveport, Louisiana 71101-4440
    United States

    Site Not Available

  • Joslin Diabetes Center at North Arundel Hospital

    Glen Burnie, Maryland 21061
    United States

    Site Not Available

  • Biolab Research, LLC

    Rockville, Maryland 20852-1542
    United States

    Site Not Available

  • Harvard University (Joslin Diabetes Center)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Genesys Integrated Group Practice, PC

    Flint, Michigan 49532
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Phillips Medical Services, PLLC

    Jackson, Mississippi 39209
    United States

    Site Not Available

  • Mississippi Medical Research, LLC

    Picayune, Mississippi 39466
    United States

    Site Not Available

  • Diabetes and Endocrinology Specialist, Inc

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Jefferson City Medical Group

    Jefferson City, Missouri 65109
    United States

    Site Not Available

  • Arms, Dodge, Robinson, Wilber & Crouch, Inc.

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Washington U School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington U School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Platte Valley Medical Group

    Kearney, Nebraska 68848
    United States

    Site Not Available

  • Creighton Diabetes Center

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Creighton Nephrology

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • UMDNJ-Robert Wood Johnson

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • University of New Mexico Health Science Center

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Downstate University of Brooklyn

    Brooklyn, New York 11203-2056
    United States

    Site Not Available

  • HRRG

    Orchard Park, New York 14127
    United States

    Site Not Available

  • SUNY - Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Meritcare Medical Group

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • Hightop Medical Research Center

    Cincinnati, Ohio 45224
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45206
    United States

    Site Not Available

  • The Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Willamette Valley Clinical Studies

    Eugene, Oregon 97404
    United States

    Site Not Available

  • Portland Hypertension and Nephrology

    Oregon City, Oregon 97045
    United States

    Site Not Available

  • Lehigh Valley Hospital-Dept. of Medicine Research

    Allentown, Pennsylvania 18105
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Renal Endocrine Associates, P. C.

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Aiken Center for Clinical Research

    Aiken, South Carolina 29801
    United States

    Site Not Available

  • Medical U of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • SC Nephrology and Hyptertension Center, Inc.

    Orangeburg, South Carolina 29115
    United States

    Site Not Available

  • Sumter Medical Specialists

    Sumter, South Carolina 29150
    United States

    Site Not Available

  • AM Diabetes and Endocrinology Center

    Bartlett, Tennessee 38133
    United States

    Site Not Available

  • Medical Nephrology Associates

    Dyersburg, Tennessee 38024
    United States

    Site Not Available

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • North Texas Endocrine Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    El Paso, Texas 79905
    United States

    Site Not Available

  • Baylor Clinic (BCM 621)

    Houston, Texas 770303411
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Allied Institute of Medicine

    San Antonio, Texas 78222
    United States

    Site Not Available

  • Renal Associates, P.A.

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Central Utah Clinic

    American Fork, Utah 84003
    United States

    Site Not Available

  • Clinical Research and Consulting Center, LLC

    Fairfax, Virginia 22030
    United States

    Site Not Available

  • Nephrology Associates of Northern Virginia

    Fairfax, Virginia 22033
    United States

    Site Not Available

  • Medical College of Virginia

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Washington State University at Spokane

    Spokane, Washington 99202
    United States

    Site Not Available

  • UW Health - West Clinic

    Madison, Wisconsin 53792
    United States

    Site Not Available

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