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

Phase 3

Completed

Conditions: Renal Insufficiency
Diabetes Mellitus, Type 2

Interventions: Drug: sitagliptin
Drug: vildagliptin

Registration Number: NCT00770081

Lead Sponsor: Novartis

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

Inclusion Criteria

Complete the core study and consent for extension

Exclusion Criteria

Patient unable to comply with core study requirements

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	sitagliptin	sitagliptin (25mg qd)
1	vildagliptin	50mg qd vildagliptin

Primary Outcome Measures

Name	Time	Method
Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest)	52 weeks

Secondary Outcome Measures

Name	Time	Method
To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment	52 weeks

Trial Locations

Locations (84): Atlanta Diabetes Associates
🇺🇸
Atlanta, Georgia, United States
Emory Clinic
🇺🇸
Atlanta, Georgia, United States
Renal Endocrine Associates, P. C.
🇺🇸
Pittsburgh, Pennsylvania, United States
Dallas Diabetes & Endocrine Center
🇺🇸
Dallas, Texas, United States
North Texas Endocrine Center
🇺🇸
Dallas, Texas, United States
John Muir Clinical Research
🇺🇸
Concord, California, United States
Sierra Clinical Research - Orangevale
🇺🇸
Roseville, California, United States
Nephrology Associates of South Miami
🇺🇸
Aventura, Florida, United States
Larry Levinson, D.O., PA
🇺🇸
Hollywood, Florida, United States
University of Hawaii
🇺🇸
Honolulu, Hawaii, United States
Baylor Clinic (BCM 621)
🇺🇸
Houston, Texas, United States
California Institute of Renal Research
🇺🇸
San Diego, California, United States
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Allied Institute of Medicine
🇺🇸
San Antonio, Texas, United States
Cray Diabetes Education Center
🇺🇸
Kansas City, Kansas, United States
Meritcare Medical Group
🇺🇸
Fargo, North Dakota, United States
Anasazi Internal Medicine
🇺🇸
Phoenix, Arizona, United States
AM Diabetes and Endocrinology Center
🇺🇸
Bartlett, Tennessee, United States
Metabolic Center of Louisiana
🇺🇸
Baton Rouge, Louisiana, United States
Sonoran Health Specialists
🇺🇸
Scottsdale, Arizona, United States
Mississippi Medical Research, LLC
🇺🇸
Picayune, Mississippi, United States
University of Arkanasas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Mary K. Richards, MD. PA
🇺🇸
Little Rock, Arkansas, United States
Egan Healthcare
🇺🇸
Metairie, Louisiana, United States
Arthritis and Diabetes Clinic
🇺🇸
Monroe, Louisiana, United States
Boise Kidney & Hypertension Institiute
🇺🇸
Meridian, Idaho, United States
Dolby Research, LLC
🇺🇸
Baton Rouge, Louisiana, United States
Bruce Samuels LLC
🇺🇸
Covington, Louisiana, United States
Crescent City Clinical Research Center
🇺🇸
Metairie, Louisiana, United States
Medical Nephrology Associates
🇺🇸
Dyersburg, Tennessee, United States
SC Nephrology and Hyptertension Center, Inc.
🇺🇸
Orangeburg, South Carolina, United States
Denver Nephrology PC
🇺🇸
Denver, Colorado, United States
Tampa Bay Nephrology Associates
🇺🇸
Tampa, Florida, United States
Creighton Diabetes Center
🇺🇸
Omaha, Nebraska, United States
Creighton Nephrology
🇺🇸
Omaha, Nebraska, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Academic Medical Research Institute
🇺🇸
Los Angeles, California, United States
Northern California Institute for Bone Health
🇺🇸
Oakland, California, United States
UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Dr. Wei Feng
🇺🇸
Pasadena, California, United States
Western Nephrology & Metabolic Bone Disease PC
🇺🇸
Westminster, Colorado, United States
Jacksonville Center for Clinical Research
🇺🇸
Jacksonville, Florida, United States
Center for Diabetes & Endocrine Care
🇺🇸
Hollywood, Florida, United States
University of Florida Shands Hospital
🇺🇸
Gainesville, Florida, United States
Osler Medical Clinical Research
🇺🇸
Melbourne, Florida, United States
Iowa Diabetes & Endocrinology Research Center PLC
🇺🇸
Des Moines, Iowa, United States
Cotton-O'Neil Diabetes & Endocrinology Center
🇺🇸
Topeka, Kansas, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States
Joslin Diabetes Center at North Arundel Hospital
🇺🇸
Glen Burnie, Maryland, United States
Harvard University (Joslin Diabetes Center)
🇺🇸
Boston, Massachusetts, United States
Genesys Integrated Group Practice, PC
🇺🇸
Flint, Michigan, United States
Biolab Research, LLC
🇺🇸
Rockville, Maryland, United States
Mayo Clinic Rochester
🇺🇸
Rochester, Minnesota, United States
Diabetes and Endocrinology Specialist, Inc
🇺🇸
Chesterfield, Missouri, United States
Jefferson City Medical Group
🇺🇸
Jefferson City, Missouri, United States
Platte Valley Medical Group
🇺🇸
Kearney, Nebraska, United States
Washington U School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Downstate University of Brooklyn
🇺🇸
Brooklyn, New York, United States
HRRG
🇺🇸
Orchard Park, New York, United States
University of New Mexico Health Science Center
🇺🇸
Albuquerque, New Mexico, United States
SUNY - Upstate Medical University
🇺🇸
Syracuse, New York, United States
Hightop Medical Research Center
🇺🇸
Cincinnati, Ohio, United States
The Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Portland Hypertension and Nephrology
🇺🇸
Oregon City, Oregon, United States
Willamette Valley Clinical Studies
🇺🇸
Eugene, Oregon, United States
Aiken Center for Clinical Research
🇺🇸
Aiken, South Carolina, United States
Lehigh Valley Hospital-Dept. of Medicine Research
🇺🇸
Allentown, Pennsylvania, United States
Sumter Medical Specialists
🇺🇸
Sumter, South Carolina, United States
Texas Tech University Health Sciences Center
🇺🇸
El Paso, Texas, United States
Renal Associates, P.A.
🇺🇸
San Antonio, Texas, United States
Central Utah Clinic
🇺🇸
American Fork, Utah, United States
Clinical Research and Consulting Center, LLC
🇺🇸
Fairfax, Virginia, United States
Nephrology Associates of Northern Virginia
🇺🇸
Fairfax, Virginia, United States
UW Health - West Clinic
🇺🇸
Madison, Wisconsin, United States
Washington State University at Spokane
🇺🇸
Spokane, Washington, United States
University of South Alabama Medical Center
🇺🇸
Mobile, Alabama, United States
Northwest Louisiana Nephrology Research
🇺🇸
Shreveport, Louisiana, United States
Phillips Medical Services, PLLC
🇺🇸
Jackson, Mississippi, United States
UMDNJ-Robert Wood Johnson
🇺🇸
New Brunswick, New Jersey, United States
Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Arms, Dodge, Robinson, Wilber & Crouch, Inc.
🇺🇸
Kansas City, Missouri, United States
Medical U of South Carolina
🇺🇸
Charleston, South Carolina, United States
Medical College of Virginia
🇺🇸
Richmond, Virginia, United States