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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00770081
First received: October 8, 2008
Last updated: January 2, 2013
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Renal Insufficiency
Drug: vildagliptin
Drug: sitagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 28-week Extension to a 24-week Multicenter, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
50mg qd vildagliptin
Drug: vildagliptin
50mg qd
Active Comparator: 2
sitagliptin (25mg qd)
Drug: sitagliptin
25mg qd

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complete the core study and consent for extension

Exclusion Criteria:

  • Patient unable to comply with core study requirements
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770081

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
United States, Arizona
Anasazi Internal Medicine
Phoenix, Arizona, United States, 85032
Sonoran Health Specialists
Scottsdale, Arizona, United States, 85260
United States, Arkansas
Mary K. Richards, MD. PA
Little Rock, Arkansas, United States, 72204
University of Arkanasas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
*Not Given*
Burlingame, California, United States, 94010
John Muir Clinical Research
Concord, California, United States, 94520
UCLA Medical Center
Los Angeles, California, United States, 90095
Academic Medical Research Institute
Los Angeles, California, United States, 90022
Northern California Institute for Bone Health
Oakland, California, United States
Dr. Wei Feng
Pasadena, California, United States, 91101
Sierra Clinical Research - Orangevale
Roseville, California, United States, 95661
California Institute of Renal Research
San Diego, California, United States, 92123
United States, Colorado
Denver Nephrology PC
Denver, Colorado, United States, 80230
Western Nephrology & Metabolic Bone Disease PC
Lakewood, Colorado, United States, 80214
Western Nephrology & Metabolic Bone Disease PC
Westminster, Colorado, United States, 80031
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Nephrology Associates of South Miami
Aventura, Florida, United States, 33180
University of Florida Shands Hospital
Gainesville, Florida, United States, 32610
Larry Levinson, D.O., PA
Hollywood, Florida, United States, 33021
Center for Diabetes & Endocrine Care
Hollywood, Florida, United States, 33021
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Osler Medical Clinical Research
Melbourne, Florida, United States, 32901
Tampa Bay Nephrology Associates
Tampa, Florida, United States, 33603
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Boise Kidney & Hypertension Institiute
Meridian, Idaho, United States, 83642
United States, Iowa
Iowa Diabetes & Endocrinology Research Center PLC
Des Moines, Iowa, United States, 50314
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Cray Diabetes Education Center
Kansas City, Kansas, United States, 66160
Cotton-O'Neil Diabetes & Endocrinology Center
Topeka, Kansas, United States, 66606
United States, Louisiana
Metabolic Center of Louisiana
Baton Rouge, Louisiana, United States, 70808
Dolby Research, LLC
Baton Rouge, Louisiana, United States, 70809
Bruce Samuels LLC
Covington, Louisiana, United States, 70433
Crescent City Clinical Research Center
Metairie, Louisiana, United States, 70006
Egan Healthcare
Metairie, Louisiana, United States, 70002
Arthritis and Diabetes Clinic
Monroe, Louisiana, United States, 71203
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, United States, 71101-4440
United States, Maryland
Joslin Diabetes Center at North Arundel Hospital
Glen Burnie, Maryland, United States, 21061
Biolab Research, LLC
Rockville, Maryland, United States, 20852-1542
United States, Massachusetts
Harvard University (Joslin Diabetes Center)
Boston, Massachusetts, United States, 02215
United States, Michigan
Genesys Integrated Group Practice, PC
Flint, Michigan, United States, 49532
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Mississippi
Phillips Medical Services, PLLC
Jackson, Mississippi, United States, 39209
Mississippi Medical Research, LLC
Picayune, Mississippi, United States, 39466
United States, Missouri
Diabetes and Endocrinology Specialist, Inc
Chesterfield, Missouri, United States, 63017
Jefferson City Medical Group
Jefferson City, Missouri, United States, 65109
Arms, Dodge, Robinson, Wilber & Crouch, Inc.
Kansas City, Missouri, United States, 64111
Washington U School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nebraska
Platte Valley Medical Group
Kearney, Nebraska, United States, 68848
Creighton Diabetes Center
Omaha, Nebraska, United States, 68131
Creighton Nephrology
Omaha, Nebraska, United States, 68131
United States, New Jersey
UMDNJ-Robert Wood Johnson
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Downstate University of Brooklyn
Brooklyn, New York, United States, 11203-2056
HRRG
Orchard Park, New York, United States, 14127
SUNY - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Dakota
Meritcare Medical Group
Fargo, North Dakota, United States, 58122
United States, Ohio
Hightop Medical Research Center
Cincinnati, Ohio, United States, 45224
University of Cincinnati
Cincinnati, Ohio, United States, 45206
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Willamette Valley Clinical Studies
Eugene, Oregon, United States, 97404
Portland Hypertension and Nephrology
Oregon City, Oregon, United States, 97045
United States, Pennsylvania
Lehigh Valley Hospital-Dept. of Medicine Research
Allentown, Pennsylvania, United States, 18105
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Renal Endocrine Associates, P. C.
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Aiken Center for Clinical Research
Aiken, South Carolina, United States, 29801
Medical U of South Carolina
Charleston, South Carolina, United States, 29425
SC Nephrology and Hyptertension Center, Inc.
Orangeburg, South Carolina, United States, 29115
Sumter Medical Specialists
Sumter, South Carolina, United States, 29150
United States, Tennessee
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, United States, 38133
Medical Nephrology Associates
Dyersburg, Tennessee, United States, 38024
United States, Texas
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230
North Texas Endocrine Center
Dallas, Texas, United States, 75231
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Baylor College of Medicine
Houston, Texas, United States, 77030
Baylor Clinic (BCM 621)
Houston, Texas, United States, 770303411
Allied Institute of Medicine
San Antonio, Texas, United States, 78222
Renal Associates, P.A.
San Antonio, Texas, United States, 78215
United States, Utah
Central Utah Clinic
American Fork, Utah, United States, 84003
United States, Virginia
Clinical Research and Consulting Center, LLC
Fairfax, Virginia, United States, 22030
Nephrology Associates of Northern Virginia
Fairfax, Virginia, United States, 22033
Medical College of Virginia
Richmond, Virginia, United States, 23298-0111
Medical College of Virginia
Richmond, Virginia, United States, 23298
United States, Washington
Washington State University at Spokane
Spokane, Washington, United States, 99202
United States, Wisconsin
UW Health - West Clinic
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00770081     History of Changes
Other Study ID Numbers: CLAF237A23138E1
Study First Received: October 8, 2008
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Sitagliptin
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014