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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00821977
Other study ID # CLAF237B2201
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date November 2008
Est. completion date October 2010

Study information

Verified date May 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 338
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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) Other protocol-defined inclusion/exclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vildagliptin

Vildagliptin

Placebo


Locations

Country Name City State
Canada LMC Endocrinology Centres (Barrie) Ltd. Barrie Ontario
Canada T.C. Health Center Carbonear Newfoundland and Labrador
Canada LMC Endocrinology Centres -(Etobicoke) Ltd. , Etobicoke Ontario
Canada G.A. Research Associates Moncton, New Brunswick E1G 1 A7 Moncton New Brunswick
Canada LMC Endocrinology Centres -(Thornhill) Thornhill Ontario
Canada LMC Endocrinology Centres (Toronto) Ltd. Toronto Ontario
India Manipal Hospital Bangalore
India MV Hospital for Diabetes and Diabetes Research Centre Chennai
India Madras Diabetes Research Foundation Gopalapuram Chennai
India Medicity Hospital Hyderabaad Hyderabad
India Diabetes Thyroid Hormone Research Institute Pvt Ltd. Indore
India Christian Medical College Vellore
Malaysia Hospital University Kebangsaan Malaysia Kuala Lumpur Selangor Darul Ehsan
Malaysia Hospital Putrajaya Selangor Darul Ehsan
Malaysia University Malaya Medical Centre Selangor Darul Ehsan Ehsan
Philippines Metropolitan Medical Center Manila
Philippines Institute for Studies on Diabetes Foundation Marikina City
Philippines Jose R. Reyes Memorial Medical Center Sta Cruz Manila
Puerto Rico Policlinica Dr. Luis Rodriguez Carrasquillo Carolina
Puerto Rico Yolanda Sierra Medical Office Levittown
Puerto Rico Endocrine Lipid Diabetes Research Institute Ponce
Puerto Rico Centro Clinico San Patricio San Juan
Puerto Rico Miguel Sosa-Padilla, M.D. San Juan
Romania CMI Cardiologie Baia Mare
Romania Paulescu Institute Bucharest
Romania Anamed SRL Oradea
Romania Emergency County Hospital Ploiesti Ploiesti
Romania Policlinica Timisoara
Slovakia Diabetologicka ambulancia Komarnanska Velky Meder
Slovakia Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia Kosice
Slovakia Diabetologicka ambulancia Nove Mesto nad Vahom
Slovakia Diabetologicka ambulancia Presov
Slovakia Diabetologicka ambulancia Sahy
Slovakia Mestska poliklinika Sered, Diabetologicka ambulancia Sered
Slovakia Diabetologicka ambulancia Trebisov
United States ACRC Trials Addison Texas
United States The Endocrine Group, LLP Albany New York
United States JMG CIinical Research Alton Illinois
United States Blair Medical Associates Inc Altoona Pennsylvania
United States Hartwell Research Group, LLC Anderson South Carolina
United States Sall Research Medical Center Artesia California
United States Southern Clinical Research Augusta Georgia
United States Fox Valley Clinical Research Aurora Illinois
United States AM Diabetes and Endocrinology Center Bartlett Tennessee
United States Dolby Research, LLC Baton Rouge Louisiana
United States Discover Research Inc. Beaumont Texas
United States MW Clinical Research Beaumont Texas
United States Tri-State Medical Group Beaver Pennsylvania
United States Madrona Medical Group - Clinical Research Dept. Bellingham Washington
United States Belzoni Clinical Research Belzoni Mississippi
United States Progressive Clinical Research Bountiful Utah
United States Tri-Cities Medical Research Bristol Tennessee
United States Discover Research Bryan Texas
United States Associated Pharmaceutical Research Buena Park California
United States Burbank - Lovelace Scientific Resources, Inc. Burbank California
United States Providence Research Burbank California
United States Cornerstone Medical Center Burlington North Carolina
United States Kernodle Clinic, Inc. Burlington North Carolina
United States Low Country Internal Medicine Charleston South Carolina
United States Pharmacorp Clinical Trials, INC Charleston South Carolina
United States Neem Research Group of Charlotte Charlotte North Carolina
United States Michigan Hypertension Center Chelsea Michigan
United States Woodlake Research Chesterfield Missouri
United States The Family Healthcare Center Clinton South Carolina
United States Colorado Springs Health Partners, Pc Colorado Springs Colorado
United States Express Care Clinical Research Colorado Springs Colorado
United States Columbia Clinical Research Columbia South Carolina
United States Rockdale Medical Research Conyers Georgia
United States Clinical Therapeutics Corp Coral Gables Florida
United States Bruce Samuels LLC Covington Louisiana
United States New England Center for Clinical Research Cranston Rhode Island
United States Z&Z Medical Associates/Internal Medicine Clinical Research Dallas Texas
United States Cherry Creek Family Practice Denver Colorado
United States Western Sky Medical Research El Paso Texas
United States North Georgia Medical Research Institute Ellijay Georgia
United States Endwell Family Physician Endwell New York
United States Lillestol Research, LLC Fargo North Dakota
United States Fleetwood Medical Associates Fleetwood Pennsylvania
United States Genesys Integrated Group Practice, PC Flint Michigan
United States Med Plus South - Strand Family Practice Garden City South Carolina
United States Horizon Clinical Research Associates, PLLC Gilbert Arizona
United States Bland Clinic, PA Greensboro North Carolina
United States Triad Clinical Trials, LLC Greensboro North Carolina
United States DeGarmo Institute of Medical Research Greer South Carolina
United States Gulfside Clinical Research Gulfport Mississippi
United States Desert Endocrinology Clinical Research Center Henderson Nevada
United States HCA Research Houston Texas
United States Texas Center for Drug Development, P.A. Houston Texas
United States American Health Network Indianapolis Indiana
United States Leading Edge Research, PA Irving Texas
United States Borgess Heart Institute-Borgess Research Institute Kalamazoo Michigan
United States Truman Medical Center & Univ Physician Associates Kansas City Missouri
United States Holston Medical Group Kingsport Tennessee
United States Gulf Coast Research, LLC Lafayette Louisiana
United States R/D Clinical Research, Inc. Lake Jackson Texas
United States Associates Research, Inc Lansing Kansas
United States Clinical Research Center of NV Las Vegas Nevada
United States Palm Medical Research Center Las Vegas Nevada
United States Family Medical Associates Levittown Pennsylvania
United States Fallbrook Family Health Center Lincoln Nebraska
United States Physician Research Collaboration Lincoln Nebraska
United States Medical Investigations, Inc. Little Rock Arkansas
United States Metro Clinical Research Littleton Colorado
United States Frederick C. Smith Clinic R & R Research Marion Ohio
United States Mercy Family Medicine Mason City Iowa
United States South Texas Institutes of Health McAllen Texas
United States Clinical Research Advantage Mesa Arizona
United States Vista Medical Research, Inc Mesa Arizona
United States Crescent City Clinical Research Center Metairie Louisiana
United States South Florida Clinical Research Center Miramar Florida
United States Joslin Diabetes Center Nashua New Hampshire
United States Hill Country Medical Associates New Braunfels Texas
United States North Shore Diabetes and Endocrine Associates New Hyde Park New York
United States Mezitis Education & Research Institute New York New York
United States Central Sooner Research Norman Oklahoma
United States Lion Research Norman Oklahoma
United States North Hills Family Practice North Richland Hills Texas
United States Complete Family Care Northglenn Colorado
United States Northport VA Medical Center Northport Virginia
United States Lucita M. Cruz, M.D., Inc. Norwalk California
United States Naidu Clinic Odessa Texas
United States Integris Physicians Services Clinical Research Oklahoma City Oklahoma
United States Memorial Clinical Research Oklahoma City Oklahoma
United States Heartland Clinical Research, Inc. Omaha Nebraska
United States Quality Clinical Research Omaha Nebraska
United States Ozark Mountains Medical Research Ozark Missouri
United States Med-Olam Clinical Research Pasadena Texas
United States Southwest Clinical Research Centers, LLC Pearland Texas
United States Advanced Clinical Research Pell City Alabama
United States Pines Research, LLC Pembroke Pines Florida
United States NISUS Research Northern MI Hospital Petoskey Michigan
United States Anasazi Internal Medicine Phoenix Arizona
United States Hope Clinical Research Phoenix Arizona
United States Tatum Ridge Internal Medicine Phoenix Arizona
United States Mississippi Medical Research, LLC Picayune Mississippi
United States Spence Medical Research Center, LLC Pinckney Michigan
United States Paul W. Davis, MD Pine Bluff Arkansas
United States Health Science Research Center Pratt Kansas
United States Private Practice Raleigh North Carolina
United States Perimeter North Medical Research Roswell Georgia
United States Midwest Pharmaceutical Research Inc. Saint Peters Missouri
United States Midwest Pharmaceutical Research, Inc. Saint Peters Missouri
United States Crescent Medical Research Salisbury North Carolina
United States Utah Clinical Trials Salt Lake City Utah
United States Diabetes & Glandular Disease Clinic , PA San Antonio Texas
United States California Research Foundation San Diego California
United States Ritchken and First MDs San Diego California
United States San Diego Sports Medicine Research and Family Care San Diego California
United States Crest Clinical Trials Santa Ana California
United States NuLife Clinical Research, Inc. Santa Ana California
United States Westside Arthritis and Metabolism Center Santa Monica California
United States Maine Centers for Endocrinology & Diabetes Scarborough Maine
United States Summit Reserach Network, LLC Seattle Washington
United States Jones Family Practice, PA Shelby North Carolina
United States The Family Doctors Shreveport Louisiana
United States Diabetes Research Center South Burlington Vermont
United States Well Pharma Medical Research South Miami Florida
United States ClinVest Research Springfield Missouri
United States Ozark Medical-Surgical Associates, Ltd. Springfield Missouri
United States The Lipid Center Statesville North Carolina
United States Southwestern Medical Clinic, PC Stevensville Michigan
United States Dorchester Medical Associates Summerville South Carolina
United States Madigan Army Medical Center Tacoma Washington
United States Southeastern Research Associates, Inc. Taylors South Carolina
United States Physicians Research Center Toms River New Jersey
United States Shore Health Group Toms River New Jersey
United States Cotton O'neil Clinic Topeka Kansas
United States Paradigm Clinical Tucson Arizona
United States Tucson Clinical Research Tucson Arizona
United States Community Research Partners, Inc. Varnville South Carolina
United States Patient's First Health Care Washington Missouri
United States Holston Medical Group Weber City Virginia
United States Center for Clinical Trials of San Gabriel West Covina California
United States Heartland Research Associates, LLC Wichita Kansas
United States Pharmacotherapy Research Associates, INC Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada,  India,  Malaysia,  Philippines,  Puerto Rico,  Romania,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
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
Secondary 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
Secondary Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM 76 weeks
Secondary 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
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