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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

ClinicalTrials.gov ID: NCT00616811

Public ClinicalTrials.gov record NCT00616811. 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 Sep 3, 2026, 8:49 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 Multi-center, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With 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 24 weeks.

Study identification

NCT ID
NCT00616811
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis
Industry
Enrollment
148 participants

Conditions and interventions

Interventions

Drug

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
Dec 31, 2007
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010
Last update posted
Dec 16, 2020

2008 – 2010

United States locations

U.S. sites
79
U.S. states
32
U.S. cities
70
Facility City State ZIP Site status
University of South Alabama Medical Center Mobile Alabama
Anasazi Internal Medicine Phoenix Arizona
University of Arkanasas for Medical Sciences Little Rock Arkansas
Office of William Zigrang Burlingame California
John Muir Clinical Research Concord California
Academic Medical Research Institute Los Angeles California
UCLA Medical Center Los Angeles California
Northern California Institute for Bone Health Oakland California
Dr. Wei Feng Pasadena California
Sierra Clinical Research - Orangevale Roseville California
Denver Nephrology PC Denver Colorado
Western Nephrology & Metabolic Bone Disease PC Lakewood Colorado
Western Nephrology & Metabolic Bone Disease PC Westminster Colorado
Hartford Hospital Hartford Connecticut
Nephrology Associates of South Miami Aventura Florida
University of Florida Shands Hospital Gainesville Florida
Center for Diabetes & Endocrine Care Hollywood Florida
Jacksonville Center for Clinical Research Jacksonville Florida
Osler Medical Clinical Research Melbourne Florida
Tampa Bay Nephrology Associates Tampa Florida
Atlanta Diabetes Associates Atlanta Georgia
Emory Clinic Atlanta Georgia
University of Hawaii Honolulu Hawaii
Boise Kidney & Hypertension Institiute Meridian Idaho
Iowa Diabetes & Endocrinology Research Center PLC Des Moines Iowa
University of Iowa Iowa City Iowa
Cray Diabetes Education Center Kansas City Kansas
Cotton-O'Neil Diabetes & Endocrinology Center Topeka Kansas
Dolby Research, LLC Baton Rouge Louisiana
Metabolic Center of Louisiana Baton Rouge Louisiana
Bruce Samuels LLC Covington Louisiana
Crescent City Clinical Research Center Metairie Louisiana
Egan Healthcare Metairie Louisiana
Arthritis and Diabetes Clinic Monroe Louisiana
Northwest Louisiana Nephrology Research Shreveport Louisiana
Joslin Diabetes Center at North Arundel Hospital Glen Burnie Maryland
Biolab Research, LLC Rockville Maryland
Genesys Integrated Group Practice, PC Flint Michigan
Phillips Medical Services, PLLC Jackson Mississippi
Mississippi Medical Research, LLC Picayune Mississippi
Diabetes and Endocrinology Specialist, Inc Chesterfield Missouri
Jefferson City Medical Group Jefferson City Missouri
Arms, Dodge, Robinson, Wilber & Crouch, Inc. Kansas City Missouri
Washington U School of Medicine St Louis Missouri
Platte Valley Medical Group Kearney Nebraska
Creighton Diabetes Center Omaha Nebraska
Creighton Nephrology Omaha Nebraska
UMDNJ-Robert Wood Johnson New Brunswick New Jersey
University of New Mexico Health Science Center Albuquerque New Mexico
Downstate University of Brooklyn Brooklyn New York
HRRG Orchard Park New York
Mayo Clinic Rochester Rochester New York
SUNY - Upstate Medical University Syracuse New York
Meritcare Medical Group Fargo North Dakota
Hightop Medical Research Center Cincinnati Ohio
University of Cincinnati Cincinnati Ohio
The Ohio State University Medical Center Columbus Ohio
Willamette Valley Clinical Studies Eugene Oregon
Lehigh Valley Hospital-Dept. of Medicine Research Allentown Pennsylvania
Thomas Jefferson University Hospital Philadelphia Pennsylvania
Renal Endocrine Associates, P. C. Pittsburgh Pennsylvania
Aiken Center for Clinical Research Aiken South Carolina
Medical U of South Carolina Charleston South Carolina
SC Nephrology and Hyptertension Center, Inc. Orangeburg South Carolina
Sumter Medical Specialists Sumter South Carolina
AM Diabetes and Endocrinology Center Bartlett Tennessee
Medical Nephrology Associates Dyersburg Tennessee
Dallas Diabetes & Endocrine Center Dallas Texas
North Texas Endocrine Center Dallas Texas
Texas Tech University Health Sciences El Paso Texas
Baylor Clinic (BCM 621) Houston Texas
Baylor College of Medicine Houston Texas
Allied Institute of Medicine San Antonio Texas
Central Utah Clinic American Fork Utah
Clinical Research and Consulting Center, LLC Fairfax Virginia
Medical College of Virginia Richmond Virginia 23298
Medical College of Virginia Richmond Virginia
Washington State University at Spokane Spokane Washington
UW Health - West Madison Wisconsin

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 NCT00616811, 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 16, 2020 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00616811 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →