Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

NCT ID: NCT00821977

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

PHASE2/PHASE3

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-10-31

Brief Summary

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This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

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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Vildagliptin Dose 1

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Vildagliptin Dose 2

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Vildagliptin

Intervention Type DRUG

Vildagliptin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients at least 18 years of age at Visit 1
* Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
* HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
* Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1

Exclusion Criteria

* Pregnant or lactating female
* FPG ≥ 270 mg/dL (≥15 mmol/L)
Minimum Eligible Age

18 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

Locations

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Advanced Clinical Research

Pell City, Alabama, United States

Site Status

Horizon Clinical Research Associates, PLLC

Gilbert, Arizona, United States

Site Status

Vista Medical Research, Inc

Mesa, Arizona, United States

Site Status

Clinical Research Advantage

Mesa, Arizona, United States

Site Status

Hope Clinical Research

Phoenix, Arizona, United States

Site Status

Anasazi Internal Medicine

Phoenix, Arizona, United States

Site Status

Tatum Ridge Internal Medicine

Phoenix, Arizona, United States

Site Status

Paradigm Clinical

Tucson, Arizona, United States

Site Status

Tucson Clinical Research

Tucson, Arizona, United States

Site Status

Medical Investigations, Inc.

Little Rock, Arkansas, United States

Site Status

Paul W. Davis, MD

Pine Bluff, Arkansas, United States

Site Status

Sall Research Medical Center

Artesia, California, United States

Site Status

Associated Pharmaceutical Research

Buena Park, California, United States

Site Status

Providence Research

Burbank, California, United States

Site Status

Burbank - Lovelace Scientific Resources, Inc.

Burbank, California, United States

Site Status

Lucita M. Cruz, M.D., Inc.

Norwalk, California, United States

Site Status

California Research Foundation

San Diego, California, United States

Site Status

Ritchken and First MDs

San Diego, California, United States

Site Status

San Diego Sports Medicine Research and Family Care

San Diego, California, United States

Site Status

Crest Clinical Trials

Santa Ana, California, United States

Site Status

NuLife Clinical Research, Inc.

Santa Ana, California, United States

Site Status

Westside Arthritis and Metabolism Center

Santa Monica, California, United States

Site Status

Center for Clinical Trials of San Gabriel

West Covina, California, United States

Site Status

Colorado Springs Health Partners, Pc

Colorado Springs, Colorado, United States

Site Status

Express Care Clinical Research

Colorado Springs, Colorado, United States

Site Status

Cherry Creek Family Practice

Denver, Colorado, United States

Site Status

Metro Clinical Research

Littleton, Colorado, United States

Site Status

Complete Family Care

Northglenn, Colorado, United States

Site Status

Clinical Therapeutics Corp

Coral Gables, Florida, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

South Florida Clinical Research Center

Miramar, Florida, United States

Site Status

Pines Research, LLC

Pembroke Pines, Florida, United States

Site Status

Well Pharma Medical Research

South Miami, Florida, United States

Site Status

Southern Clinical Research

Augusta, Georgia, United States

Site Status

Rockdale Medical Research

Conyers, Georgia, United States

Site Status

North Georgia Medical Research Institute

Ellijay, Georgia, United States

Site Status

Perimeter North Medical Research

Roswell, Georgia, United States

Site Status

JMG CIinical Research

Alton, Illinois, United States

Site Status

Fox Valley Clinical Research

Aurora, Illinois, United States

Site Status

American Health Network

Indianapolis, Indiana, United States

Site Status

Mercy Family Medicine

Mason City, Iowa, United States

Site Status

Associates Research, Inc

Lansing, Kansas, United States

Site Status

Health Science Research Center

Pratt, Kansas, United States

Site Status

Cotton O'neil Clinic

Topeka, Kansas, United States

Site Status

Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

Dolby Research, LLC

Baton Rouge, Louisiana, United States

Site Status

Bruce Samuels LLC

Covington, Louisiana, United States

Site Status

Gulf Coast Research, LLC

Lafayette, Louisiana, United States

Site Status

Crescent City Clinical Research Center

Metairie, Louisiana, United States

Site Status

The Family Doctors

Shreveport, Louisiana, United States

Site Status

Maine Centers for Endocrinology & Diabetes

Scarborough, Maine, United States

Site Status

Michigan Hypertension Center

Chelsea, Michigan, United States

Site Status

Genesys Integrated Group Practice, PC

Flint, Michigan, United States

Site Status

Borgess Heart Institute-Borgess Research Institute

Kalamazoo, Michigan, United States

Site Status

NISUS Research Northern MI Hospital

Petoskey, Michigan, United States

Site Status

Spence Medical Research Center, LLC

Pinckney, Michigan, United States

Site Status

Southwestern Medical Clinic, PC

Stevensville, Michigan, United States

Site Status

Belzoni Clinical Research

Belzoni, Mississippi, United States

Site Status

Gulfside Clinical Research

Gulfport, Mississippi, United States

Site Status

Mississippi Medical Research, LLC

Picayune, Mississippi, United States

Site Status

Woodlake Research

Chesterfield, Missouri, United States

Site Status

Midwest Pharmaceutical Research Inc.

City of Saint Peters, Missouri, United States

Site Status

Midwest Pharmaceutical Research, Inc.

City of Saint Peters, Missouri, United States

Site Status

Truman Medical Center & Univ Physician Associates

Kansas City, Missouri, United States

Site Status

Ozark Mountains Medical Research

Ozark, Missouri, United States

Site Status

Ozark Medical-Surgical Associates, Ltd.

Springfield, Missouri, United States

Site Status

ClinVest Research

Springfield, Missouri, United States

Site Status

Patient's First Health Care

Washington, Missouri, United States

Site Status

Physician Research Collaboration

Lincoln, Nebraska, United States

Site Status

Fallbrook Family Health Center

Lincoln, Nebraska, United States

Site Status

Quality Clinical Research

Omaha, Nebraska, United States

Site Status

Heartland Clinical Research, Inc.

Omaha, Nebraska, United States

Site Status

Desert Endocrinology Clinical Research Center

Henderson, Nevada, United States

Site Status

Clinical Research Center of NV

Las Vegas, Nevada, United States

Site Status

Palm Medical Research Center

Las Vegas, Nevada, United States

Site Status

Joslin Diabetes Center

Nashua, New Hampshire, United States

Site Status

Shore Health Group

Toms River, New Jersey, United States

Site Status

Physicians Research Center

Toms River, New Jersey, United States

Site Status

The Endocrine Group, LLP

Albany, New York, United States

Site Status

Endwell Family Physician

Endwell, New York, United States

Site Status

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, United States

Site Status

Mezitis Education & Research Institute

New York, New York, United States

Site Status

Cornerstone Medical Center

Burlington, North Carolina, United States

Site Status

Kernodle Clinic, Inc.

Burlington, North Carolina, United States

Site Status

Neem Research Group of Charlotte

Charlotte, North Carolina, United States

Site Status

Bland Clinic, PA

Greensboro, North Carolina, United States

Site Status

Triad Clinical Trials, LLC

Greensboro, North Carolina, United States

Site Status

Private Practice

Raleigh, North Carolina, United States

Site Status

Crescent Medical Research

Salisbury, North Carolina, United States

Site Status

Jones Family Practice, PA

Shelby, North Carolina, United States

Site Status

The Lipid Center

Statesville, North Carolina, United States

Site Status

Lillestol Research, LLC

Fargo, North Dakota, United States

Site Status

Frederick C. Smith Clinic R & R Research

Marion, Ohio, United States

Site Status

Pharmacotherapy Research Associates, INC

Zanesville, Ohio, United States

Site Status

Central Sooner Research

Norman, Oklahoma, United States

Site Status

Lion Research

Norman, Oklahoma, United States

Site Status

Integris Physicians Services Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Memorial Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Blair Medical Associates Inc

Altoona, Pennsylvania, United States

Site Status

Tri-State Medical Group

Beaver, Pennsylvania, United States

Site Status

Fleetwood Medical Associates

Fleetwood, Pennsylvania, United States

Site Status

Family Medical Associates

Levittown, Pennsylvania, United States

Site Status

New England Center for Clinical Research

Cranston, Rhode Island, United States

Site Status

Hartwell Research Group, LLC

Anderson, South Carolina, United States

Site Status

Low Country Internal Medicine

Charleston, South Carolina, United States

Site Status

Pharmacorp Clinical Trials, INC

Charleston, South Carolina, United States

Site Status

The Family Healthcare Center

Clinton, South Carolina, United States

Site Status

Columbia Clinical Research

Columbia, South Carolina, United States

Site Status

Med Plus South - Strand Family Practice

Garden City, South Carolina, United States

Site Status

DeGarmo Institute of Medical Research

Greer, South Carolina, United States

Site Status

Dorchester Medical Associates

Summerville, South Carolina, United States

Site Status

Southeastern Research Associates, Inc.

Taylors, South Carolina, United States

Site Status

Community Research Partners, Inc.

Varnville, South Carolina, United States

Site Status

AM Diabetes and Endocrinology Center

Bartlett, Tennessee, United States

Site Status

Tri-Cities Medical Research

Bristol, Tennessee, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

ACRC Trials

Addison, Texas, United States

Site Status

Discover Research Inc.

Beaumont, Texas, United States

Site Status

MW Clinical Research

Beaumont, Texas, United States

Site Status

Discover Research

Bryan, Texas, United States

Site Status

Z&Z Medical Associates/Internal Medicine Clinical Research

Dallas, Texas, United States

Site Status

Western Sky Medical Research

El Paso, Texas, United States

Site Status

HCA Research

Houston, Texas, United States

Site Status

Texas Center for Drug Development, P.A.

Houston, Texas, United States

Site Status

Leading Edge Research, PA

Irving, Texas, United States

Site Status

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Site Status

South Texas Institutes of Health

McAllen, Texas, United States

Site Status

Hill Country Medical Associates

New Braunfels, Texas, United States

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North Hills Family Practice

North Richland Hills, Texas, United States

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Naidu Clinic

Odessa, Texas, United States

Site Status

Med-Olam Clinical Research

Pasadena, Texas, United States

Site Status

Southwest Clinical Research Centers, LLC

Pearland, Texas, United States

Site Status

Diabetes & Glandular Disease Clinic , PA

San Antonio, Texas, United States

Site Status

Progressive Clinical Research

Bountiful, Utah, United States

Site Status

Utah Clinical Trials

Salt Lake City, Utah, United States

Site Status

Diabetes Research Center

South Burlington, Vermont, United States

Site Status

Northport VA Medical Center

Northport, Virginia, United States

Site Status

Holston Medical Group

Weber City, Virginia, United States

Site Status

Madrona Medical Group - Clinical Research Dept.

Bellingham, Washington, United States

Site Status

Summit Reserach Network, LLC

Seattle, Washington, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

G.A. Research Associates Moncton, New Brunswick E1G 1 A7

Moncton, New Brunswick, Canada

Site Status

T.C. Health Center

Carbonear, Newfoundland and Labrador, Canada

Site Status

LMC Endocrinology Centres (Barrie) Ltd.

Barrie, Ontario, Canada

Site Status

LMC Endocrinology Centres -(Etobicoke) Ltd. ,

Etobicoke, Ontario, Canada

Site Status

LMC Endocrinology Centres -(Thornhill)

Thornhill, Ontario, Canada

Site Status

LMC Endocrinology Centres (Toronto) Ltd.

Toronto, Ontario, Canada

Site Status

Madras Diabetes Research Foundation

Gopālapuram, Chennai, India

Site Status

Medicity Hospital

Hyderabaad, Hyderabad, India

Site Status

Manipal Hospital

Bangalore, , India

Site Status

MV Hospital for Diabetes and Diabetes Research Centre

Chennai, , India

Site Status

Diabetes Thyroid Hormone Research Institute Pvt Ltd.

Indore, , India

Site Status

Christian Medical College

Vellore, , India

Site Status

University Malaya Medical Centre

Selangor Darul Ehsan, Ehsan, Malaysia

Site Status

Hospital University Kebangsaan Malaysia

Kuala Lumpur, Selangor, Malaysia

Site Status

Hospital Putrajaya

Selangor Darul Ehsan, Selangor, Malaysia

Site Status

Jose R. Reyes Memorial Medical Center

Sta Cruz, Manila, Philippines

Site Status

Metropolitan Medical Center

Manila, , Philippines

Site Status

Institute for Studies on Diabetes Foundation

Marikina City, , Philippines

Site Status

Policlinica Dr. Luis Rodriguez Carrasquillo

Carolina, , Puerto Rico

Site Status

Yolanda Sierra Medical Office

Levittown, , Puerto Rico

Site Status

Endocrine Lipid Diabetes Research Institute

Ponce, , Puerto Rico

Site Status

Centro Clinico San Patricio

San Juan, , Puerto Rico

Site Status

Miguel Sosa-Padilla, M.D.

San Juan, , Puerto Rico

Site Status

CMI Cardiologie

Baia Mare, , Romania

Site Status

Paulescu Institute

Bucharest, , Romania

Site Status

Anamed SRL

Oradea, , Romania

Site Status

Emergency County Hospital Ploiesti

Ploieşti, , Romania

Site Status

Policlinica

Timișoara, , Romania

Site Status

Diabetologicka ambulancia

Komarnanska, Velky Meder, Slovakia

Site Status

Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia

Košice, , Slovakia

Site Status

Diabetologicka ambulancia

Nové Mesto nad Váhom, , Slovakia

Site Status

Diabetologicka ambulancia

Prešov, , Slovakia

Site Status

Mestska poliklinika Sered, Diabetologicka ambulancia

Sereď, , Slovakia

Site Status

Diabetologicka ambulancia

Šahy, , Slovakia

Site Status

Diabetologicka ambulancia

Trebišov, , Slovakia

Site Status

Countries

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United States Canada India Malaysia Philippines Puerto Rico Romania Slovakia

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4586

Results for CLAF237B2201 from the Novartis Clinical Trials website

Other Identifiers

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CLAF237B2201

Identifier Type: -

Identifier Source: org_study_id

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