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

NCT ID: NCT00770081

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-04-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2 Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

50mg qd vildagliptin

Group Type EXPERIMENTAL

vildagliptin

Intervention Type DRUG

50mg qd

2

sitagliptin (25mg qd)

Group Type ACTIVE_COMPARATOR

sitagliptin

Intervention Type DRUG

25mg qd

Interventions

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vildagliptin

50mg qd

Intervention Type DRUG

sitagliptin

25mg qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Complete the core study and consent for extension

Exclusion Criteria

* Patient unable to comply with core study requirements
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of South Alabama Medical Center

Mobile, Alabama, United States

Site Status

Anasazi Internal Medicine

Phoenix, Arizona, United States

Site Status

Sonoran Health Specialists

Scottsdale, Arizona, United States

Site Status

Mary K. Richards, MD. PA

Little Rock, Arkansas, United States

Site Status

University of Arkanasas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Burlingame, California, United States

Site Status

John Muir Clinical Research

Concord, California, United States

Site Status

Academic Medical Research Institute

Los Angeles, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

Northern California Institute for Bone Health

Oakland, California, United States

Site Status

Dr. Wei Feng

Pasadena, California, United States

Site Status

Sierra Clinical Research - Orangevale

Roseville, California, United States

Site Status

California Institute of Renal Research

San Diego, California, United States

Site Status

Denver Nephrology PC

Denver, Colorado, United States

Site Status

Western Nephrology & Metabolic Bone Disease PC

Lakewood, Colorado, United States

Site Status

Western Nephrology & Metabolic Bone Disease PC

Westminster, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Nephrology Associates of South Miami

Aventura, Florida, United States

Site Status

University of Florida Shands Hospital

Gainesville, Florida, United States

Site Status

Center for Diabetes & Endocrine Care

Hollywood, Florida, United States

Site Status

Larry Levinson, D.O., PA

Hollywood, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Osler Medical Clinical Research

Melbourne, Florida, United States

Site Status

Tampa Bay Nephrology Associates

Tampa, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Emory Clinic

Atlanta, Georgia, United States

Site Status

University of Hawaii

Honolulu, Hawaii, United States

Site Status

Boise Kidney & Hypertension Institiute

Meridian, Idaho, United States

Site Status

Iowa Diabetes & Endocrinology Research Center PLC

Des Moines, Iowa, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Cray Diabetes Education Center

Kansas City, Kansas, United States

Site Status

Cotton-O'Neil Diabetes & Endocrinology Center

Topeka, Kansas, United States

Site Status

Metabolic Center of Louisiana

Baton Rouge, Louisiana, United States

Site Status

Dolby Research, LLC

Baton Rouge, Louisiana, United States

Site Status

Bruce Samuels LLC

Covington, Louisiana, United States

Site Status

Egan Healthcare

Metairie, Louisiana, United States

Site Status

Crescent City Clinical Research Center

Metairie, Louisiana, United States

Site Status

Arthritis and Diabetes Clinic

Monroe, Louisiana, United States

Site Status

Northwest Louisiana Nephrology Research

Shreveport, Louisiana, United States

Site Status

Joslin Diabetes Center at North Arundel Hospital

Glen Burnie, Maryland, United States

Site Status

Biolab Research, LLC

Rockville, Maryland, United States

Site Status

Harvard University (Joslin Diabetes Center)

Boston, Massachusetts, United States

Site Status

Genesys Integrated Group Practice, PC

Flint, Michigan, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Phillips Medical Services, PLLC

Jackson, Mississippi, United States

Site Status

Mississippi Medical Research, LLC

Picayune, Mississippi, United States

Site Status

Diabetes and Endocrinology Specialist, Inc

Chesterfield, Missouri, United States

Site Status

Jefferson City Medical Group

Jefferson City, Missouri, United States

Site Status

Arms, Dodge, Robinson, Wilber & Crouch, Inc.

Kansas City, Missouri, United States

Site Status

Washington U School of Medicine

St Louis, Missouri, United States

Site Status

Platte Valley Medical Group

Kearney, Nebraska, United States

Site Status

Creighton Diabetes Center

Omaha, Nebraska, United States

Site Status

Creighton Nephrology

Omaha, Nebraska, United States

Site Status

UMDNJ-Robert Wood Johnson

New Brunswick, New Jersey, United States

Site Status

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States

Site Status

Downstate University of Brooklyn

Brooklyn, New York, United States

Site Status

HRRG

Orchard Park, New York, United States

Site Status

SUNY - Upstate Medical University

Syracuse, New York, United States

Site Status

Meritcare Medical Group

Fargo, North Dakota, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Hightop Medical Research Center

Cincinnati, Ohio, United States

Site Status

The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Willamette Valley Clinical Studies

Eugene, Oregon, United States

Site Status

Portland Hypertension and Nephrology

Oregon City, Oregon, United States

Site Status

Lehigh Valley Hospital-Dept. of Medicine Research

Allentown, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Renal Endocrine Associates, P. C.

Pittsburgh, Pennsylvania, United States

Site Status

Aiken Center for Clinical Research

Aiken, South Carolina, United States

Site Status

Medical U of South Carolina

Charleston, South Carolina, United States

Site Status

SC Nephrology and Hyptertension Center, Inc.

Orangeburg, South Carolina, United States

Site Status

Sumter Medical Specialists

Sumter, South Carolina, United States

Site Status

AM Diabetes and Endocrinology Center

Bartlett, Tennessee, United States

Site Status

Medical Nephrology Associates

Dyersburg, Tennessee, United States

Site Status

Dallas Diabetes & Endocrine Center

Dallas, Texas, United States

Site Status

North Texas Endocrine Center

Dallas, Texas, United States

Site Status

Texas Tech University Health Sciences Center

El Paso, Texas, United States

Site Status

Baylor Clinic (BCM 621)

Houston, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Renal Associates, P.A.

San Antonio, Texas, United States

Site Status

Allied Institute of Medicine

San Antonio, Texas, United States

Site Status

Central Utah Clinic

American Fork, Utah, United States

Site Status

Clinical Research and Consulting Center, LLC

Fairfax, Virginia, United States

Site Status

Nephrology Associates of Northern Virginia

Fairfax, Virginia, United States

Site Status

Medical College of Virginia

Richmond, Virginia, United States

Site Status

Medical College of Virginia

Richmond, Virginia, United States

Site Status

Washington State University at Spokane

Spokane, Washington, United States

Site Status

UW Health - West Clinic

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5923

Results for CLAF237A23138E1 from the Novartis Clinical Trials website

Other Identifiers

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CLAF237A23138E1

Identifier Type: -

Identifier Source: org_study_id

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