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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00770081

Public ClinicalTrials.gov record NCT00770081. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 11:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00770081
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis
Industry
Enrollment
75 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2008 (Type not available)
Primary completion
Apr 2011 (Actual)
Completion
Apr 2011 (Actual)
Last update posted
Dec 17, 2020

2008 – 2011

United States locations

U.S. sites
87
U.S. states
34
U.S. cities
74
Facility City State ZIP Site status
University of South Alabama Medical Center Mobile Alabama 36617 —
Anasazi Internal Medicine Phoenix Arizona 85032 —
Sonoran Health Specialists Scottsdale Arizona 85260 —
Mary K. Richards, MD. PA Little Rock Arkansas 72204 —
University of Arkanasas for Medical Sciences Little Rock Arkansas 72205 —
Not listed Burlingame California 94010 —
John Muir Clinical Research Concord California 94520 —
Academic Medical Research Institute Los Angeles California 90022 —
UCLA Medical Center Los Angeles California 90095 —
Northern California Institute for Bone Health Oakland California — —
Dr. Wei Feng Pasadena California 91101 —
Sierra Clinical Research - Orangevale Roseville California 95661 —
California Institute of Renal Research San Diego California 92123 —
Denver Nephrology PC Denver Colorado 80230 —
Western Nephrology & Metabolic Bone Disease PC Lakewood Colorado 80214 —
Western Nephrology & Metabolic Bone Disease PC Westminster Colorado 80031 —
Hartford Hospital Hartford Connecticut 06102 —
Nephrology Associates of South Miami Aventura Florida 33180 —
University of Florida Shands Hospital Gainesville Florida 32610 —
Center for Diabetes & Endocrine Care Hollywood Florida 33021 —
Larry Levinson, D.O., PA Hollywood Florida 33021 —
Jacksonville Center for Clinical Research Jacksonville Florida 32216 —
Osler Medical Clinical Research Melbourne Florida 32901 —
Tampa Bay Nephrology Associates Tampa Florida 33603 —
Atlanta Diabetes Associates Atlanta Georgia 30309 —
Emory Clinic Atlanta Georgia 30322 —
University of Hawaii Honolulu Hawaii 96813 —
Boise Kidney & Hypertension Institiute Meridian Idaho 83642 —
Iowa Diabetes & Endocrinology Research Center PLC Des Moines Iowa 50314 —
University of Iowa Iowa City Iowa 52242 —
Cray Diabetes Education Center Kansas City Kansas 66160 —
Cotton-O'Neil Diabetes & Endocrinology Center Topeka Kansas 66606 —
Metabolic Center of Louisiana Baton Rouge Louisiana 70808 —
Dolby Research, LLC Baton Rouge Louisiana 70809 —
Bruce Samuels LLC Covington Louisiana 70433 —
Egan Healthcare Metairie Louisiana 70002 —
Crescent City Clinical Research Center Metairie Louisiana 70006 —
Arthritis and Diabetes Clinic Monroe Louisiana 71203 —
Northwest Louisiana Nephrology Research Shreveport Louisiana 71101-4440 —
Joslin Diabetes Center at North Arundel Hospital Glen Burnie Maryland 21061 —
Biolab Research, LLC Rockville Maryland 20852-1542 —
Harvard University (Joslin Diabetes Center) Boston Massachusetts 02215 —
Genesys Integrated Group Practice, PC Flint Michigan 49532 —
Mayo Clinic Rochester Rochester Minnesota 55905 —
Phillips Medical Services, PLLC Jackson Mississippi 39209 —
Mississippi Medical Research, LLC Picayune Mississippi 39466 —
Diabetes and Endocrinology Specialist, Inc Chesterfield Missouri 63017 —
Jefferson City Medical Group Jefferson City Missouri 65109 —
Arms, Dodge, Robinson, Wilber & Crouch, Inc. Kansas City Missouri 64111 —
Washington U School of Medicine St Louis Missouri 63110 —
Platte Valley Medical Group Kearney Nebraska 68848 —
Creighton Diabetes Center Omaha Nebraska 68131 —
Creighton Nephrology Omaha Nebraska 68131 —
UMDNJ-Robert Wood Johnson New Brunswick New Jersey 08903 —
University of New Mexico Health Science Center Albuquerque New Mexico 87131 —
Downstate University of Brooklyn Brooklyn New York 11203-2056 —
HRRG Orchard Park New York 14127 —
SUNY - Upstate Medical University Syracuse New York 13210 —
Meritcare Medical Group Fargo North Dakota 58122 —
University of Cincinnati Cincinnati Ohio 45206 —
Hightop Medical Research Center Cincinnati Ohio 45224 —
The Ohio State University Medical Center Columbus Ohio 43210 —
Willamette Valley Clinical Studies Eugene Oregon 97404 —
Portland Hypertension and Nephrology Oregon City Oregon 97045 —
Lehigh Valley Hospital-Dept. of Medicine Research Allentown Pennsylvania 18105 —
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 —
Renal Endocrine Associates, P. C. Pittsburgh Pennsylvania 15224 —
Aiken Center for Clinical Research Aiken South Carolina 29801 —
Medical U of South Carolina Charleston South Carolina 29425 —
SC Nephrology and Hyptertension Center, Inc. Orangeburg South Carolina 29115 —
Sumter Medical Specialists Sumter South Carolina 29150 —
AM Diabetes and Endocrinology Center Bartlett Tennessee 38133 —
Medical Nephrology Associates Dyersburg Tennessee 38024 —
Dallas Diabetes & Endocrine Center Dallas Texas 75230 —
North Texas Endocrine Center Dallas Texas 75231 —
Texas Tech University Health Sciences Center El Paso Texas 79905 —
Baylor Clinic (BCM 621) Houston Texas 770303411 —
Baylor College of Medicine Houston Texas 77030 —
Renal Associates, P.A. San Antonio Texas 78215 —
Allied Institute of Medicine San Antonio Texas 78222 —
Central Utah Clinic American Fork Utah 84003 —
Clinical Research and Consulting Center, LLC Fairfax Virginia 22030 —
Nephrology Associates of Northern Virginia Fairfax Virginia 22033 —
Medical College of Virginia Richmond Virginia 23298-0111 —
Medical College of Virginia Richmond Virginia 23298 —
Washington State University at Spokane Spokane Washington 99202 —
UW Health - West Clinic Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00770081, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 17, 2020 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00770081 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →