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

Last updated: December 11, 2020
Sponsor: Novartis
Overall Status: Completed

Phase

2/3

Condition

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT00821977
CLAF237B2201
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant or lactating female
  • FPG ≥ 270 mg/dL (≥15 mmol/L) Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 338
Study Start date:
November 01, 2008
Estimated Completion Date:
October 31, 2010

Connect with a study center

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

    Moncton, New Brunswick E1G 1 A7
    Canada

    Site Not Available

  • T.C. Health Center

    Carbonear, Newfoundland and Labrador A1Y 1C4
    Canada

    Site Not Available

  • LMC Endocrinology Centres (Barrie) Ltd.

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • LMC Endocrinology Centres -(Etobicoke) Ltd. ,

    Etobicoke, Ontario M9R 4E1
    Canada

    Site Not Available

  • LMC Endocrinology Centres -(Thornhill)

    Thornhill, Ontario L4J 8L7
    Canada

    Site Not Available

  • LMC Endocrinology Centres (Toronto) Ltd.

    Toronto, Ontario M4R 2G4
    Canada

    Site Not Available

  • Madras Diabetes Research Foundation

    Gopalapuram, Chennai 600 086
    India

    Site Not Available

  • Medicity Hospital

    Hyderabaad, Hyderabad 500 036
    India

    Site Not Available

  • Manipal Hospital

    Bangalore, 560 017
    India

    Site Not Available

  • MV Hospital for Diabetes and Diabetes Research Centre

    Chennai, 600 013
    India

    Site Not Available

  • Diabetes Thyroid Hormone Research Institute Pvt Ltd.

    Indore, 452 001
    India

    Site Not Available

  • Christian Medical College

    Vellore, 632 004
    India

    Site Not Available

  • University Malaya Medical Centre

    Selangor Darul Ehsan, Ehsan
    Malaysia

    Site Not Available

  • Hospital University Kebangsaan Malaysia

    Kuala Lumpur, Selangor Darul Ehsan
    Malaysia

    Site Not Available

  • Hospital Putrajaya

    Selangor Darul Ehsan,
    Malaysia

    Site Not Available

  • Jose R. Reyes Memorial Medical Center

    Sta Cruz, Manila
    Philippines

    Site Not Available

  • Metropolitan Medical Center

    Manila,
    Philippines

    Site Not Available

  • Institute for Studies on Diabetes Foundation

    Marikina City,
    Philippines

    Site Not Available

  • Policlinica Dr. Luis Rodriguez Carrasquillo

    Carolina, 00983
    Puerto Rico

    Site Not Available

  • Yolanda Sierra Medical Office

    Levittown, 00949
    Puerto Rico

    Site Not Available

  • Endocrine Lipid Diabetes Research Institute

    Ponce, 00717-1471
    Puerto Rico

    Site Not Available

  • Centro Clinico San Patricio

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Miguel Sosa-Padilla, M.D.

    San Juan, 00926
    Puerto Rico

    Site Not Available

  • CMI Cardiologie

    Baia Mare,
    Romania

    Site Not Available

  • Paulescu Institute

    Bucharest,
    Romania

    Site Not Available

  • Anamed SRL

    Oradea,
    Romania

    Site Not Available

  • Emergency County Hospital Ploiesti

    Ploiesti,
    Romania

    Site Not Available

  • Policlinica

    Timisoara,
    Romania

    Site Not Available

  • Diabetologicka ambulancia

    Komarnanska, Velky Meder 932 01
    Slovakia

    Site Not Available

  • Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia

    Kosice, 040 01
    Slovakia

    Site Not Available

  • Diabetologicka ambulancia

    Nove Mesto nad Vahom, 915 01
    Slovakia

    Site Not Available

  • Diabetologicka ambulancia

    Presov,
    Slovakia

    Site Not Available

  • Diabetologicka ambulancia

    Sahy, 936 01
    Slovakia

    Site Not Available

  • Mestska poliklinika Sered, Diabetologicka ambulancia

    Sered, 926 01
    Slovakia

    Site Not Available

  • Diabetologicka ambulancia

    Trebisov, 075 01
    Slovakia

    Site Not Available

  • Advanced Clinical Research

    Pell City, Alabama 35128
    United States

    Site Not Available

  • Horizon Clinical Research Associates, PLLC

    Gilbert, Arizona 85206
    United States

    Site Not Available

  • Clinical Research Advantage

    Mesa, Arizona 85213
    United States

    Site Not Available

  • Vista Medical Research, Inc

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Anasazi Internal Medicine

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Hope Clinical Research

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Tatum Ridge Internal Medicine

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Paradigm Clinical

    Tucson, Arizona 85705
    United States

    Site Not Available

  • Tucson Clinical Research

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Medical Investigations, Inc.

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Paul W. Davis, MD

    Pine Bluff, Arkansas 71603
    United States

    Site Not Available

  • Sall Research Medical Center

    Artesia, California 90704
    United States

    Site Not Available

  • Associated Pharmaceutical Research

    Buena Park, California 90620
    United States

    Site Not Available

  • Burbank - Lovelace Scientific Resources, Inc.

    Burbank, California 91506
    United States

    Site Not Available

  • Providence Research

    Burbank, California 91505
    United States

    Site Not Available

  • Lucita M. Cruz, M.D., Inc.

    Norwalk, California 90650
    United States

    Site Not Available

  • California Research Foundation

    San Diego, California 92103
    United States

    Site Not Available

  • Ritchken and First MDs

    San Diego, California 92117-4961
    United States

    Site Not Available

  • San Diego Sports Medicine Research and Family Care

    San Diego, California 92120
    United States

    Site Not Available

  • Crest Clinical Trials

    Santa Ana, California 92701
    United States

    Site Not Available

  • NuLife Clinical Research, Inc.

    Santa Ana, California 92805
    United States

    Site Not Available

  • Westside Arthritis and Metabolism Center

    Santa Monica, California 90404
    United States

    Site Not Available

  • Center for Clinical Trials of San Gabriel

    West Covina, California 91790
    United States

    Site Not Available

  • Colorado Springs Health Partners, Pc

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Express Care Clinical Research

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Cherry Creek Family Practice

    Denver, Colorado 80206
    United States

    Site Not Available

  • Metro Clinical Research

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Complete Family Care

    Northglenn, Colorado 80234
    United States

    Site Not Available

  • Clinical Therapeutics Corp

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • South Florida Clinical Research Center

    Miramar, Florida 33023
    United States

    Site Not Available

  • Pines Research, LLC

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • Well Pharma Medical Research

    South Miami, Florida 33143
    United States

    Site Not Available

  • Southern Clinical Research

    Augusta, Georgia 30904
    United States

    Site Not Available

  • Rockdale Medical Research

    Conyers, Georgia 30094
    United States

    Site Not Available

  • North Georgia Medical Research Institute

    Ellijay, Georgia 30540
    United States

    Site Not Available

  • Perimeter North Medical Research

    Roswell, Georgia 30076
    United States

    Site Not Available

  • JMG CIinical Research

    Alton, Illinois 62002
    United States

    Site Not Available

  • Fox Valley Clinical Research

    Aurora, Illinois 60504
    United States

    Site Not Available

  • American Health Network

    Indianapolis, Indiana 46254
    United States

    Site Not Available

  • Mercy Family Medicine

    Mason City, Iowa 50401
    United States

    Site Not Available

  • Associates Research, Inc

    Lansing, Kansas 66043
    United States

    Site Not Available

  • Health Science Research Center

    Pratt, Kansas 67124
    United States

    Site Not Available

  • Cotton O'neil Clinic

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Heartland Research Associates, LLC

    Wichita, Kansas 67205
    United States

    Site Not Available

  • Dolby Research, LLC

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Bruce Samuels LLC

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Gulf Coast Research, LLC

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • Crescent City Clinical Research Center

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • The Family Doctors

    Shreveport, Louisiana 71115
    United States

    Site Not Available

  • Maine Centers for Endocrinology & Diabetes

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Michigan Hypertension Center

    Chelsea, Michigan 48118
    United States

    Site Not Available

  • Genesys Integrated Group Practice, PC

    Flint, Michigan 48532
    United States

    Site Not Available

  • Borgess Heart Institute-Borgess Research Institute

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • NISUS Research Northern MI Hospital

    Petoskey, Michigan 49770-2212
    United States

    Site Not Available

  • Spence Medical Research Center, LLC

    Pinckney, Michigan 39466
    United States

    Site Not Available

  • Southwestern Medical Clinic, PC

    Stevensville, Michigan 49127
    United States

    Site Not Available

  • Belzoni Clinical Research

    Belzoni, Mississippi 39038
    United States

    Site Not Available

  • Gulfside Clinical Research

    Gulf Port, Mississippi 39501
    United States

    Site Not Available

  • Gulfside Clinical Research

    Gulfport, Mississippi 39501
    United States

    Site Not Available

  • Mississippi Medical Research, LLC

    Picayune, Mississippi 39466
    United States

    Site Not Available

  • Woodlake Research

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Truman Medical Center & Univ Physician Associates

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Ozark Mountains Medical Research

    Ozark, Missouri 65721
    United States

    Site Not Available

  • Midwest Pharmaceutical Research Inc.

    Saint Peters, Missouri 63376
    United States

    Site Not Available

  • Midwest Pharmaceutical Research, Inc.

    Saint Peters, Missouri 63376
    United States

    Site Not Available

  • ClinVest Research

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Ozark Medical-Surgical Associates, Ltd.

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Midwest Pharmaceutical Research Inc.

    St. Peters, Missouri 63376
    United States

    Site Not Available

  • Patient's First Health Care

    Washington, Missouri 63090
    United States

    Site Not Available

  • Fallbrook Family Health Center

    Lincoln, Nebraska 68521
    United States

    Site Not Available

  • Physician Research Collaboration

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Heartland Clinical Research, Inc.

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Quality Clinical Research

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Desert Endocrinology Clinical Research Center

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Clinical Research Center of NV

    Las Vegas, Nevada 89104
    United States

    Site Not Available

  • Palm Medical Research Center

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Joslin Diabetes Center

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Physicians Research Center

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Shore Health Group

    Toms River, New Jersey 08753
    United States

    Site Not Available

  • The Endocrine Group, LLP

    Albany, New York 12206
    United States

    Site Not Available

  • Endwell Family Physician

    Endwell, New York 13760
    United States

    Site Not Available

  • North Shore Diabetes and Endocrine Associates

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Mezitis Education & Research Institute

    New York, New York 10024
    United States

    Site Not Available

  • Cornerstone Medical Center

    Burlington, North Carolina 27215
    United States

    Site Not Available

  • Kernodle Clinic, Inc.

    Burlington, North Carolina 27215
    United States

    Site Not Available

  • Neem Research Group of Charlotte

    Charlotte, North Carolina 28262
    United States

    Site Not Available

  • Bland Clinic, PA

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Triad Clinical Trials, LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Private Practice

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Crescent Medical Research

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Jones Family Practice, PA

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • The Lipid Center

    Statesville, North Carolina 28677
    United States

    Site Not Available

  • Lillestol Research, LLC

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Frederick C. Smith Clinic R & R Research

    Marion, Ohio 43302
    United States

    Site Not Available

  • Pharmacotherapy Research Associates, INC

    Zanesville, Ohio 43071
    United States

    Site Not Available

  • Central Sooner Research

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Lion Research

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Integris Physicians Services Clinical Research

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Memorial Clinical Research

    Oklahoma City, Oklahoma 73134
    United States

    Site Not Available

  • Blair Medical Associates Inc

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Tri-State Medical Group

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Fleetwood Medical Associates

    Fleetwood, Pennsylvania 19522
    United States

    Site Not Available

  • Family Medical Associates

    Levittown, Pennsylvania 19056
    United States

    Site Not Available

  • New England Center for Clinical Research

    Cranston, Rhode Island 02920
    United States

    Site Not Available

  • Hartwell Research Group, LLC

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Low Country Internal Medicine

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Pharmacorp Clinical Trials, INC

    Charleston, South Carolina 29412
    United States

    Site Not Available

  • The Family Healthcare Center

    Clinton, South Carolina 29325
    United States

    Site Not Available

  • Columbia Clinical Research

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Med Plus South - Strand Family Practice

    Garden City, South Carolina 29576
    United States

    Site Not Available

  • DeGarmo Institute of Medical Research

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Dorchester Medical Associates

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • Southeastern Research Associates, Inc.

    Taylors, South Carolina 28687
    United States

    Site Not Available

  • Community Research Partners, Inc.

    Varnville, South Carolina 29944
    United States

    Site Not Available

  • AM Diabetes and Endocrinology Center

    Bartlett, Tennessee 38133
    United States

    Site Not Available

  • Tri-Cities Medical Research

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • ACRC Trials

    Addison, Texas 75093
    United States

    Site Not Available

  • Discover Research Inc.

    Beaumont, Texas 77701
    United States

    Site Not Available

  • MW Clinical Research

    Beaumont, Texas 77701
    United States

    Site Not Available

  • Discover Research

    Bryan, Texas 77802
    United States

    Site Not Available

  • Z&Z Medical Associates/Internal Medicine Clinical Research

    Dallas, Texas 75235
    United States

    Site Not Available

  • Western Sky Medical Research

    El Paso, Texas 79902
    United States

    Site Not Available

  • HCA Research

    Houston, Texas 77025
    United States

    Site Not Available

  • Texas Center for Drug Development, P.A.

    Houston, Texas 77081
    United States

    Site Not Available

  • Leading Edge Research, PA

    Irving, Texas 75039
    United States

    Site Not Available

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas 77566
    United States

    Site Not Available

  • South Texas Institutes of Health

    McAllen, Texas 78501
    United States

    Site Not Available

  • Hill Country Medical Associates

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • North Hills Family Practice

    North Richard Hills, Texas 76180
    United States

    Site Not Available

  • North Hills Family Practice

    North Richland Hills, Texas 76180
    United States

    Site Not Available

  • Naidu Clinic

    Odessa, Texas 79761
    United States

    Site Not Available

  • Med-Olam Clinical Research

    Pasadena, Texas 77504
    United States

    Site Not Available

  • Southwest Clinical Research Centers, LLC

    Pearland, Texas 77584
    United States

    Site Not Available

  • Diabetes & Glandular Disease Clinic , PA

    San Antonio, Texas 78237
    United States

    Site Not Available

  • Progressive Clinical Research

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Utah Clinical Trials

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Diabetes Research Center

    South Burlington, Vermont 05403
    United States

    Site Not Available

  • Northport VA Medical Center

    Northport, Virginia 11768
    United States

    Site Not Available

  • Holston Medical Group

    Weber City, Virginia 24920
    United States

    Site Not Available

  • Madrona Medical Group - Clinical Research Dept.

    Bellingham, Washington 98226
    United States

    Site Not Available

  • Summit Reserach Network, LLC

    Seattle, Washington 98104
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98431
    United States

    Site Not Available

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