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Clinical Trial Details

Trial ID: L7341
Source ID: NCT00821977
Associated Drug: Vildagliptin
Title: Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Vildagliptin|DRUG: Vildagliptin|DRUG: Placebo
Outcome Measures: Primary: Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks., 24 weeks | Secondary: Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks, 24 weeks|Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM, 24 weeks|Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM, 76 weeks|Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM, 24 weeks
Sponsor/Collaborators: Sponsor: Novartis
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 338
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-11
Completion Date: 2010-10
Results First Posted:
Last Update Posted: 2020-12-17
Locations: Advanced Clinical Research, Pell City, Alabama, 35128, United States|Horizon Clinical Research Associates, PLLC, Gilbert, Arizona, 85206, United States|Vista Medical Research, Inc, Mesa, Arizona, 85206, United States|Clinical Research Advantage, Mesa, Arizona, 85213, United States|Hope Clinical Research, Phoenix, Arizona, 85006, United States|Anasazi Internal Medicine, Phoenix, Arizona, 85032, United States|Tatum Ridge Internal Medicine, Phoenix, Arizona, 85032, United States|Paradigm Clinical, Tucson, Arizona, 85705, United States|Tucson Clinical Research, Tucson, Arizona, 85712, United States|Medical Investigations, Inc., Little Rock, Arkansas, 72205, United States|Paul W. Davis, MD, Pine Bluff, Arkansas, 71603, United States|Sall Research Medical Center, Artesia, California, 90704, United States|Associated Pharmaceutical Research, Buena Park, California, 90620, United States|Providence Research, Burbank, California, 91505, United States|Burbank - Lovelace Scientific Resources, Inc., Burbank, California, 91506, United States|Lucita M. Cruz, M.D., Inc., Norwalk, California, 90650, United States|California Research Foundation, San Diego, California, 92103, United States|Ritchken and First MDs, San Diego, California, 92117-4961, United States|San Diego Sports Medicine Research and Family Care, San Diego, California, 92120, United States|Crest Clinical Trials, Santa Ana, California, 92701, United States|NuLife Clinical Research, Inc., Santa Ana, California, 92805, United States|Westside Arthritis and Metabolism Center, Santa Monica, California, 90404, United States|Center for Clinical Trials of San Gabriel, West Covina, California, 91790, United States|Colorado Springs Health Partners, Pc, Colorado Springs, Colorado, 80907, United States|Express Care Clinical Research, Colorado Springs, Colorado, 80909, United States|Cherry Creek Family Practice, Denver, Colorado, 80206, United States|Metro Clinical Research, Littleton, Colorado, 80120, United States|Complete Family Care, Northglenn, Colorado, 80234, United States|Clinical Therapeutics Corp, Coral Gables, Florida, 33134, United States|Fort Lauderdale, Florida, 33308, United States|South Florida Clinical Research Center, Miramar, Florida, 33023, United States|Pines Research, LLC, Pembroke Pines, Florida, 33028, United States|Well Pharma Medical Research, South Miami, Florida, 33143, United States|Southern Clinical Research, Augusta, Georgia, 30904, United States|Rockdale Medical Research, Conyers, Georgia, 30094, United States|North Georgia Medical Research Institute, Ellijay, Georgia, 30540, United States|Perimeter North Medical Research, Roswell, Georgia, 30076, United States|JMG CIinical Research, Alton, Illinois, 62002, United States|Fox Valley Clinical Research, Aurora, Illinois, 60504, United States|American Health Network, Indianapolis, Indiana, 46254, United States|Mercy Family Medicine, Mason City, Iowa, 50401, United States|Associates Research, Inc, Lansing, Kansas, 66043, United States|Health Science Research Center, Pratt, Kansas, 67124, United States|Cotton O'neil Clinic, Topeka, Kansas, 66606, United States|Heartland Research Associates, LLC, Wichita, Kansas, 67205, United States|Dolby Research, LLC, Baton Rouge, Louisiana, 70809, United States|Bruce Samuels LLC, Covington, Louisiana, 70433, United States|Gulf Coast Research, LLC, Lafayette, Louisiana, 70508, United States|Crescent City Clinical Research Center, Metairie, Louisiana, 70006, United States|The Family Doctors, Shreveport, Louisiana, 71115, United States|Maine Centers for Endocrinology & Diabetes, Scarborough, Maine, 04074, United States|Michigan Hypertension Center, Chelsea, Michigan, 48118, United States|Genesys Integrated Group Practice, PC, Flint, Michigan, 48532, United States|Borgess Heart Institute-Borgess Research Institute, Kalamazoo, Michigan, 49048, United States|NISUS Research Northern MI Hospital, Petoskey, Michigan, 49770-2212, United States|Spence Medical Research Center, LLC, Pinckney, Michigan, 39466, United States|Southwestern Medical Clinic, PC, Stevensville, Michigan, 49127, United States|Belzoni Clinical Research, Belzoni, Mississippi, 39038, United States|Gulfside Clinical Research, Gulfport, Mississippi, 39501, United States|Mississippi Medical Research, LLC, Picayune, Mississippi, 39466, United States|Woodlake Research, Chesterfield, Missouri, 63017, United States|Truman Medical Center & Univ Physician Associates, Kansas City, Missouri, 64108, United States|Ozark Mountains Medical Research, Ozark, Missouri, 65721, United States|Midwest Pharmaceutical Research Inc., Saint Peters, Missouri, 63376, United States|Midwest Pharmaceutical Research, Inc., Saint Peters, Missouri, 63376, United States|Ozark Medical-Surgical Associates, Ltd., Springfield, Missouri, 65804, United States|ClinVest Research, Springfield, Missouri, 65807, United States|Patient's First Health Care, Washington, Missouri, 63090, United States|Physician Research Collaboration, Lincoln, Nebraska, 68516, United States|Fallbrook Family Health Center, Lincoln, Nebraska, 68521, United States|Quality Clinical Research, Omaha, Nebraska, 68114, United States|Heartland Clinical Research, Inc., Omaha, Nebraska, 68134, United States|Desert Endocrinology Clinical Research Center, Henderson, Nevada, 89052, United States|Clinical Research Center of NV, Las Vegas, Nevada, 89104, United States|Palm Medical Research Center, Las Vegas, Nevada, 89148, United States|Joslin Diabetes Center, Nashua, New Hampshire, 03063, United States|Shore Health Group, Toms River, New Jersey, 08753, United States|Physicians Research Center, Toms River, New Jersey, 08755, United States|The Endocrine Group, LLP, Albany, New York, 12206, United States|Endwell Family Physician, Endwell, New York, 13760, United States|North Shore Diabetes and Endocrine Associates, New Hyde Park, New York, 11042, United States|Mezitis Education & Research Institute, New York, New York, 10024, United States|Cornerstone Medical Center, Burlington, North Carolina, 27215, United States|Kernodle Clinic, Inc., Burlington, North Carolina, 27215, United States|Neem Research Group of Charlotte, Charlotte, North Carolina, 28262, United States|Bland Clinic, PA, Greensboro, North Carolina, 27401, United States|Triad Clinical Trials, LLC, Greensboro, North Carolina, 27408, United States|Private Practice, Raleigh, North Carolina, 27610, United States|Crescent Medical Research, Salisbury, North Carolina, 28144, United States|Jones Family Practice, PA, Shelby, North Carolina, 28150, United States|The Lipid Center, Statesville, North Carolina, 28677, United States|Lillestol Research, LLC, Fargo, North Dakota, 58103, United States|Frederick C. Smith Clinic R & R Research, Marion, Ohio, 43302, United States|Pharmacotherapy Research Associates, INC, Zanesville, Ohio, 43071, United States|Central Sooner Research, Norman, Oklahoma, 73069, United States|Lion Research, Norman, Oklahoma, 73069, United States|Integris Physicians Services Clinical Research, Oklahoma City, Oklahoma, 73112, United States|Memorial Clinical Research, Oklahoma City, Oklahoma, 73134, United States|Blair Medical Associates Inc, Altoona, Pennsylvania, 16602, United States|Tri-State Medical Group, Beaver, Pennsylvania, 15009, United States|Fleetwood Medical Associates, Fleetwood, Pennsylvania, 19522, United States|Family Medical Associates, Levittown, Pennsylvania, 19056, United States|New England Center for Clinical Research, Cranston, Rhode Island, 02920, United States|Hartwell Research Group, LLC, Anderson, South Carolina, 29621, United States|Low Country Internal Medicine, Charleston, South Carolina, 29406, United States|Pharmacorp Clinical Trials, INC, Charleston, South Carolina, 29412, United States|The Family Healthcare Center, Clinton, South Carolina, 29325, United States|Columbia Clinical Research, Columbia, South Carolina, 29201, United States|Med Plus South - Strand Family Practice, Garden City, South Carolina, 29576, United States|DeGarmo Institute of Medical Research, Greer, South Carolina, 29651, United States|Dorchester Medical Associates, Summerville, South Carolina, 29485, United States|Southeastern Research Associates, Inc., Taylors, South Carolina, 28687, United States|Community Research Partners, Inc., Varnville, South Carolina, 29944, United States|AM Diabetes and Endocrinology Center, Bartlett, Tennessee, 38133, United States|Tri-Cities Medical Research, Bristol, Tennessee, 37620, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|ACRC Trials, Addison, Texas, 75093, United States|Discover Research Inc., Beaumont, Texas, 77701, United States|MW Clinical Research, Beaumont, Texas, 77701, United States|Discover Research, Bryan, Texas, 77802, United States|Z&Z Medical Associates/Internal Medicine Clinical Research, Dallas, Texas, 75235, United States|Western Sky Medical Research, El Paso, Texas, 79902, United States|HCA Research, Houston, Texas, 77025, United States|Texas Center for Drug Development, P.A., Houston, Texas, 77081, United States|Leading Edge Research, PA, Irving, Texas, 75039, United States|R/D Clinical Research, Inc., Lake Jackson, Texas, 77566, United States|South Texas Institutes of Health, McAllen, Texas, 78501, United States|Hill Country Medical Associates, New Braunfels, Texas, 78130, United States|North Hills Family Practice, North Richland Hills, Texas, 76180, United States|Naidu Clinic, Odessa, Texas, 79761, United States|Med-Olam Clinical Research, Pasadena, Texas, 77504, United States|Southwest Clinical Research Centers, LLC, Pearland, Texas, 77584, United States|Diabetes & Glandular Disease Clinic , PA, San Antonio, Texas, 78237, United States|Progressive Clinical Research, Bountiful, Utah, 84010, United States|Utah Clinical Trials, Salt Lake City, Utah, 84107, United States|Diabetes Research Center, South Burlington, Vermont, 05403, United States|Northport VA Medical Center, Northport, Virginia, 11768, United States|Holston Medical Group, Weber City, Virginia, 24920, United States|Madrona Medical Group - Clinical Research Dept., Bellingham, Washington, 98226, United States|Summit Reserach Network, LLC, Seattle, Washington, 98104, United States|Madigan Army Medical Center, Tacoma, Washington, 98431, United States|G.A. Research Associates Moncton, New Brunswick E1G 1 A7, Moncton, New Brunswick, E1G 1 A7, Canada|T.C. Health Center, Carbonear, Newfoundland and Labrador, A1Y 1C4, Canada|LMC Endocrinology Centres (Barrie) Ltd., Barrie, Ontario, L4M 7G1, Canada|LMC Endocrinology Centres -(Etobicoke) Ltd. ,, Etobicoke, Ontario, M9R 4E1, Canada|LMC Endocrinology Centres -(Thornhill), Thornhill, Ontario, L4J 8L7, Canada|LMC Endocrinology Centres (Toronto) Ltd., Toronto, Ontario, M4R 2G4, Canada|Madras Diabetes Research Foundation, Gopalapuram, Chennai, 600 086, India|Medicity Hospital, Hyderabaad, Hyderabad, 500 036, India|Manipal Hospital, Bangalore, 560 017, India|MV Hospital for Diabetes and Diabetes Research Centre, Chennai, 600 013, India|Diabetes Thyroid Hormone Research Institute Pvt Ltd., Indore, 452 001, India|Christian Medical College, Vellore, 632 004, India|University Malaya Medical Centre, Selangor Darul Ehsan, Ehsan, Malaysia|Hospital University Kebangsaan Malaysia, Kuala Lumpur, Selangor Darul Ehsan, Malaysia|Hospital Putrajaya, Selangor Darul Ehsan, Malaysia|Jose R. Reyes Memorial Medical Center, Sta Cruz, Manila, Philippines|Metropolitan Medical Center, Manila, Philippines|Institute for Studies on Diabetes Foundation, Marikina City, Philippines|Policlinica Dr. Luis Rodriguez Carrasquillo, Carolina, 00983, Puerto Rico|Yolanda Sierra Medical Office, Levittown, 00949, Puerto Rico|Endocrine Lipid Diabetes Research Institute, Ponce, 00717-1471, Puerto Rico|Centro Clinico San Patricio, San Juan, 00921, Puerto Rico|Miguel Sosa-Padilla, M.D., San Juan, 00926, Puerto Rico|CMI Cardiologie, Baia Mare, Romania|Paulescu Institute, Bucharest, Romania|Anamed SRL, Oradea, Romania|Emergency County Hospital Ploiesti, Ploiesti, Romania|Policlinica, Timisoara, Romania|Diabetologicka ambulancia, Komarnanska, Velky Meder, 932 01, Slovakia|Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia, Kosice, 040 01, Slovakia|Diabetologicka ambulancia, Nove Mesto nad Vahom, 915 01, Slovakia|Diabetologicka ambulancia, Presov, Slovakia|Diabetologicka ambulancia, Sahy, 936 01, Slovakia|Mestska poliklinika Sered, Diabetologicka ambulancia, Sered, 926 01, Slovakia|Diabetologicka ambulancia, Trebisov, 075 01, Slovakia
URL: https://clinicaltrials.gov/show/NCT00821977