Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)
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
1 other identifier
interventional
75
1 country
87
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Sep 2008
Longer than P75 for phase_3 diabetes-mellitus-type-2
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 8, 2008
CompletedFirst Posted
Study publicly available on registry
October 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedDecember 17, 2020
May 1, 2012
2.6 years
October 8, 2008
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest)
52 weeks
Secondary Outcomes (1)
To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment
52 weeks
Study Arms (2)
1
EXPERIMENTAL50mg qd vildagliptin
2
ACTIVE COMPARATORsitagliptin (25mg qd)
Interventions
Eligibility Criteria
You may qualify if:
- Complete the core study and consent for extension
You may not qualify if:
- Patient unable to comply with core study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (87)
University of South Alabama Medical Center
Mobile, Alabama, 36617, United States
Anasazi Internal Medicine
Phoenix, Arizona, 85032, United States
Sonoran Health Specialists
Scottsdale, Arizona, 85260, United States
Mary K. Richards, MD. PA
Little Rock, Arkansas, 72204, United States
University of Arkanasas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Unknown Facility
Burlingame, California, 94010, United States
John Muir Clinical Research
Concord, California, 94520, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Northern California Institute for Bone Health
Oakland, California, United States
Dr. Wei Feng
Pasadena, California, 91101, United States
Sierra Clinical Research - Orangevale
Roseville, California, 95661, United States
California Institute of Renal Research
San Diego, California, 92123, United States
Denver Nephrology PC
Denver, Colorado, 80230, United States
Western Nephrology & Metabolic Bone Disease PC
Lakewood, Colorado, 80214, United States
Western Nephrology & Metabolic Bone Disease PC
Westminster, Colorado, 80031, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Nephrology Associates of South Miami
Aventura, Florida, 33180, United States
University of Florida Shands Hospital
Gainesville, Florida, 32610, United States
Center for Diabetes & Endocrine Care
Hollywood, Florida, 33021, United States
Larry Levinson, D.O., PA
Hollywood, Florida, 33021, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Osler Medical Clinical Research
Melbourne, Florida, 32901, United States
Tampa Bay Nephrology Associates
Tampa, Florida, 33603, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30309, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Boise Kidney & Hypertension Institiute
Meridian, Idaho, 83642, United States
Iowa Diabetes & Endocrinology Research Center PLC
Des Moines, Iowa, 50314, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Cray Diabetes Education Center
Kansas City, Kansas, 66160, United States
Cotton-O'Neil Diabetes & Endocrinology Center
Topeka, Kansas, 66606, United States
Metabolic Center of Louisiana
Baton Rouge, Louisiana, 70808, United States
Dolby Research, LLC
Baton Rouge, Louisiana, 70809, United States
Bruce Samuels LLC
Covington, Louisiana, 70433, United States
Egan Healthcare
Metairie, Louisiana, 70002, United States
Crescent City Clinical Research Center
Metairie, Louisiana, 70006, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203, United States
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, 71101-4440, United States
Joslin Diabetes Center at North Arundel Hospital
Glen Burnie, Maryland, 21061, United States
Biolab Research, LLC
Rockville, Maryland, 20852-1542, United States
Harvard University (Joslin Diabetes Center)
Boston, Massachusetts, 02215, United States
Genesys Integrated Group Practice, PC
Flint, Michigan, 49532, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Phillips Medical Services, PLLC
Jackson, Mississippi, 39209, United States
Mississippi Medical Research, LLC
Picayune, Mississippi, 39466, United States
Diabetes and Endocrinology Specialist, Inc
Chesterfield, Missouri, 63017, United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109, United States
Arms, Dodge, Robinson, Wilber & Crouch, Inc.
Kansas City, Missouri, 64111, United States
Washington U School of Medicine
St Louis, Missouri, 63110, United States
Platte Valley Medical Group
Kearney, Nebraska, 68848, United States
Creighton Diabetes Center
Omaha, Nebraska, 68131, United States
Creighton Nephrology
Omaha, Nebraska, 68131, United States
UMDNJ-Robert Wood Johnson
New Brunswick, New Jersey, 08903, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131, United States
Downstate University of Brooklyn
Brooklyn, New York, 11203-2056, United States
HRRG
Orchard Park, New York, 14127, United States
SUNY - Upstate Medical University
Syracuse, New York, 13210, United States
Meritcare Medical Group
Fargo, North Dakota, 58122, United States
University of Cincinnati
Cincinnati, Ohio, 45206, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Portland Hypertension and Nephrology
Oregon City, Oregon, 97045, United States
Lehigh Valley Hospital-Dept. of Medicine Research
Allentown, Pennsylvania, 18105, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Renal Endocrine Associates, P. C.
Pittsburgh, Pennsylvania, 15224, United States
Aiken Center for Clinical Research
Aiken, South Carolina, 29801, United States
Medical U of South Carolina
Charleston, South Carolina, 29425, United States
SC Nephrology and Hyptertension Center, Inc.
Orangeburg, South Carolina, 29115, United States
Sumter Medical Specialists
Sumter, South Carolina, 29150, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133, United States
Medical Nephrology Associates
Dyersburg, Tennessee, 38024, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
Baylor Clinic (BCM 621)
Houston, Texas, 770303411, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Renal Associates, P.A.
San Antonio, Texas, 78215, United States
Allied Institute of Medicine
San Antonio, Texas, 78222, United States
Central Utah Clinic
American Fork, Utah, 84003, United States
Clinical Research and Consulting Center, LLC
Fairfax, Virginia, 22030, United States
Nephrology Associates of Northern Virginia
Fairfax, Virginia, 22033, United States
Medical College of Virginia
Richmond, Virginia, 23298-0111, United States
Medical College of Virginia
Richmond, Virginia, 23298, United States
Washington State University at Spokane
Spokane, Washington, 99202, United States
UW Health - West Clinic
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2008
First Posted
October 9, 2008
Study Start
September 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
December 17, 2020
Record last verified: 2012-05