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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 Oct 19, 2026, 6:41 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
Jan 2008 (Type not available)
Primary completion
Oct 2010 (Actual)
Completion
Oct 2010 (Actual)
Last update posted
Dec 17, 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 17, 2020 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00616811 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →