Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes
- Registration Number
- NCT00821977
- Lead Sponsor
- Novartis
- Brief Summary
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 338
- 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
- Pregnant or lactating female
- FPG ≥ 270 mg/dL (≥15 mmol/L)
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Vildagliptin Dose 1 Vildagliptin - Vildagliptin Dose 2 Vildagliptin -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (170)
G.A. Research Associates Moncton, New Brunswick E1G 1 A7
🇨🇦Moncton, New Brunswick, Canada
AM Diabetes and Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
Ozark Medical-Surgical Associates, Ltd.
🇺🇸Springfield, Missouri, United States
Texas Center for Drug Development, P.A.
🇺🇸Houston, Texas, United States
American Health Network
🇺🇸Indianapolis, Indiana, United States
Clinical Research Advantage
🇺🇸Mesa, Arizona, United States
Community Research Partners, Inc.
🇺🇸Varnville, South Carolina, United States
Gulfside Clinical Research
🇺🇸Gulfport, Mississippi, United States
Pharmacorp Clinical Trials, INC
🇺🇸Charleston, South Carolina, United States
Christian Medical College
🇮🇳Vellore, India
Hospital University Kebangsaan Malaysia
🇲🇾Kuala Lumpur, Selangor Darul Ehsan, Malaysia
Hospital Putrajaya
🇲🇾Selangor Darul Ehsan, Malaysia
Mississippi Medical Research, LLC
🇺🇸Picayune, Mississippi, United States
Dorchester Medical Associates
🇺🇸Summerville, South Carolina, United States
Paul W. Davis, MD
🇺🇸Pine Bluff, Arkansas, United States
Medical Investigations, Inc.
🇺🇸Little Rock, Arkansas, United States
Physician Research Collaboration
🇺🇸Lincoln, Nebraska, United States
Hartwell Research Group, LLC
🇺🇸Anderson, South Carolina, United States
Centro Clinico San Patricio
🇵🇷San Juan, Puerto Rico
Policlinica
🇷🇴Timisoara, Romania
Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia
🇸🇰Kosice, Slovakia
Crescent City Clinical Research Center
🇺🇸Metairie, Louisiana, United States
Belzoni Clinical Research
🇺🇸Belzoni, Mississippi, United States
Diabetes Thyroid Hormone Research Institute Pvt Ltd.
🇮🇳Indore, India
Policlinica Dr. Luis Rodriguez Carrasquillo
🇵🇷Carolina, Puerto Rico
Bruce Samuels LLC
🇺🇸Covington, Louisiana, United States
T.C. Health Center
🇨🇦Carbonear, Newfoundland and Labrador, Canada
The Family Doctors
🇺🇸Shreveport, Louisiana, United States
University Malaya Medical Centre
🇲🇾Selangor Darul Ehsan, Ehsan, Malaysia
Jose R. Reyes Memorial Medical Center
🇵🇭Sta Cruz, Manila, Philippines
Metropolitan Medical Center
🇵🇭Manila, Philippines
Mestska poliklinika Sered, Diabetologicka ambulancia
🇸🇰Sered, Slovakia
Tri-Cities Medical Research
🇺🇸Bristol, Tennessee, United States
Med Plus South - Strand Family Practice
🇺🇸Garden City, South Carolina, United States
Metro Clinical Research
🇺🇸Littleton, Colorado, United States
Providence Research
🇺🇸Burbank, California, United States
Gulf Coast Research, LLC
🇺🇸Lafayette, Louisiana, United States
Cotton O'neil Clinic
🇺🇸Topeka, Kansas, United States
Burbank - Lovelace Scientific Resources, Inc.
🇺🇸Burbank, California, United States
Ritchken and First MDs
🇺🇸San Diego, California, United States
Associated Pharmaceutical Research
🇺🇸Buena Park, California, United States
Mercy Family Medicine
🇺🇸Mason City, Iowa, United States
Truman Medical Center & Univ Physician Associates
🇺🇸Kansas City, Missouri, United States
Express Care Clinical Research
🇺🇸Colorado Springs, Colorado, United States
Pines Research, LLC
🇺🇸Pembroke Pines, Florida, United States
Horizon Clinical Research Associates, PLLC
🇺🇸Gilbert, Arizona, United States
San Diego Sports Medicine Research and Family Care
🇺🇸San Diego, California, United States
Lucita M. Cruz, M.D., Inc.
🇺🇸Norwalk, California, United States
Colorado Springs Health Partners, Pc
🇺🇸Colorado Springs, Colorado, United States
Vista Medical Research, Inc
🇺🇸Mesa, Arizona, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
Crest Clinical Trials
🇺🇸Santa Ana, California, United States
Westside Arthritis and Metabolism Center
🇺🇸Santa Monica, California, United States
California Research Foundation
🇺🇸San Diego, California, United States
Advanced Clinical Research
🇺🇸Pell City, Alabama, United States
Dolby Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
Rockdale Medical Research
🇺🇸Conyers, Georgia, United States
Michigan Hypertension Center
🇺🇸Chelsea, Michigan, United States
Associates Research, Inc
🇺🇸Lansing, Kansas, United States
Fox Valley Clinical Research
🇺🇸Aurora, Illinois, United States
Maine Centers for Endocrinology & Diabetes
🇺🇸Scarborough, Maine, United States
JMG CIinical Research
🇺🇸Alton, Illinois, United States
North Georgia Medical Research Institute
🇺🇸Ellijay, Georgia, United States
Well Pharma Medical Research
🇺🇸South Miami, Florida, United States
Midwest Pharmaceutical Research, Inc.
🇺🇸Saint Peters, Missouri, United States
Shore Health Group
🇺🇸Toms River, New Jersey, United States
Ozark Mountains Medical Research
🇺🇸Ozark, Missouri, United States
Southern Clinical Research
🇺🇸Augusta, Georgia, United States
Midwest Pharmaceutical Research Inc.
🇺🇸Saint Peters, Missouri, United States
Borgess Heart Institute-Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
Joslin Diabetes Center
🇺🇸Nashua, New Hampshire, United States
Desert Endocrinology Clinical Research Center
🇺🇸Henderson, Nevada, United States
Southwestern Medical Clinic, PC
🇺🇸Stevensville, Michigan, United States
Endwell Family Physician
🇺🇸Endwell, New York, United States
MW Clinical Research
🇺🇸Beaumont, Texas, United States
Spence Medical Research Center, LLC
🇺🇸Pinckney, Michigan, United States
Private Practice
🇺🇸Raleigh, North Carolina, United States
Clinical Research Center of NV
🇺🇸Las Vegas, Nevada, United States
Palm Medical Research Center
🇺🇸Las Vegas, Nevada, United States
Mezitis Education & Research Institute
🇺🇸New York, New York, United States
Neem Research Group of Charlotte
🇺🇸Charlotte, North Carolina, United States
The Family Healthcare Center
🇺🇸Clinton, South Carolina, United States
Discover Research Inc.
🇺🇸Beaumont, Texas, United States
Triad Clinical Trials, LLC
🇺🇸Greensboro, North Carolina, United States
Fleetwood Medical Associates
🇺🇸Fleetwood, Pennsylvania, United States
Columbia Clinical Research
🇺🇸Columbia, South Carolina, United States
ACRC Trials
🇺🇸Addison, Texas, United States
Lion Research
🇺🇸Norman, Oklahoma, United States
Bland Clinic, PA
🇺🇸Greensboro, North Carolina, United States
The Lipid Center
🇺🇸Statesville, North Carolina, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Diabetes & Glandular Disease Clinic , PA
🇺🇸San Antonio, Texas, United States
Tri-State Medical Group
🇺🇸Beaver, Pennsylvania, United States
Southeastern Research Associates, Inc.
🇺🇸Taylors, South Carolina, United States
Med-Olam Clinical Research
🇺🇸Pasadena, Texas, United States
Leading Edge Research, PA
🇺🇸Irving, Texas, United States
Holston Medical Group
🇺🇸Weber City, Virginia, United States
Northport VA Medical Center
🇺🇸Northport, Virginia, United States
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
Diabetes Research Center
🇺🇸South Burlington, Vermont, United States
Z&Z Medical Associates/Internal Medicine Clinical Research
🇺🇸Dallas, Texas, United States
Medicity Hospital
🇮🇳Hyderabaad, Hyderabad, India
Manipal Hospital
🇮🇳Bangalore, India
Family Medical Associates
🇺🇸Levittown, Pennsylvania, United States
DeGarmo Institute of Medical Research
🇺🇸Greer, South Carolina, United States
HCA Research
🇺🇸Houston, Texas, United States
Madras Diabetes Research Foundation
🇮🇳Gopalapuram, Chennai, India
Diabetologicka ambulancia
🇸🇰Trebisov, Slovakia
Hill Country Medical Associates
🇺🇸New Braunfels, Texas, United States
Summit Reserach Network, LLC
🇺🇸Seattle, Washington, United States
North Hills Family Practice
🇺🇸North Richland Hills, Texas, United States
Utah Clinical Trials
🇺🇸Salt Lake City, Utah, United States
Southwest Clinical Research Centers, LLC
🇺🇸Pearland, Texas, United States
Institute for Studies on Diabetes Foundation
🇵🇭Marikina City, Philippines
Yolanda Sierra Medical Office
🇵🇷Levittown, Puerto Rico
Anamed SRL
🇷🇴Oradea, Romania
LMC Endocrinology Centres (Toronto) Ltd.
🇨🇦Toronto, Ontario, Canada
MV Hospital for Diabetes and Diabetes Research Centre
🇮🇳Chennai, India
Miguel Sosa-Padilla, M.D.
🇵🇷San Juan, Puerto Rico
Endocrine Lipid Diabetes Research Institute
🇵🇷Ponce, Puerto Rico
Emergency County Hospital Ploiesti
🇷🇴Ploiesti, Romania
CMI Cardiologie
🇷🇴Baia Mare, Romania
Paulescu Institute
🇷🇴Bucharest, Romania
Hope Clinical Research
🇺🇸Phoenix, Arizona, United States
Anasazi Internal Medicine
🇺🇸Phoenix, Arizona, United States
Tatum Ridge Internal Medicine
🇺🇸Phoenix, Arizona, United States
Cherry Creek Family Practice
🇺🇸Denver, Colorado, 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
Complete Family Care
🇺🇸Northglenn, Colorado, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
South Texas Institutes of Health
🇺🇸McAllen, Texas, United States
Paradigm Clinical
🇺🇸Tucson, Arizona, United States
Tucson Clinical Research
🇺🇸Tucson, Arizona, United States
Frederick C. Smith Clinic R & R Research
🇺🇸Marion, Ohio, United States
Woodlake Research
🇺🇸Chesterfield, Missouri, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
The Endocrine Group, LLP
🇺🇸Albany, New York, United States
North Shore Diabetes and Endocrine Associates
🇺🇸New Hyde Park, New York, United States
Cornerstone Medical Center
🇺🇸Burlington, North Carolina, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Blair Medical Associates Inc
🇺🇸Altoona, Pennsylvania, United States
LMC Endocrinology Centres -(Thornhill)
🇨🇦Thornhill, Ontario, Canada
Perimeter North Medical Research
🇺🇸Roswell, Georgia, United States
NuLife Clinical Research, Inc.
🇺🇸Santa Ana, California, United States
South Florida Clinical Research Center
🇺🇸Miramar, Florida, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Genesys Integrated Group Practice, PC
🇺🇸Flint, Michigan, United States
Health Science Research Center
🇺🇸Pratt, Kansas, United States
NISUS Research Northern MI Hospital
🇺🇸Petoskey, Michigan, United States
Patient's First Health Care
🇺🇸Washington, Missouri, United States
ClinVest Research
🇺🇸Springfield, Missouri, United States
Fallbrook Family Health Center
🇺🇸Lincoln, Nebraska, United States
Physicians Research Center
🇺🇸Toms River, New Jersey, United States
Kernodle Clinic, Inc.
🇺🇸Burlington, North Carolina, United States
Jones Family Practice, PA
🇺🇸Shelby, North Carolina, United States
Pharmacotherapy Research Associates, INC
🇺🇸Zanesville, Ohio, United States
Low Country Internal Medicine
🇺🇸Charleston, South Carolina, United States
New England Center for Clinical Research
🇺🇸Cranston, Rhode Island, United States
Naidu Clinic
🇺🇸Odessa, Texas, United States
Progressive Clinical Research
🇺🇸Bountiful, Utah, United States
LMC Endocrinology Centres -(Etobicoke) Ltd. ,
🇨🇦Etobicoke, Ontario, Canada
Madrona Medical Group - Clinical Research Dept.
🇺🇸Bellingham, Washington, United States
LMC Endocrinology Centres (Barrie) Ltd.
🇨🇦Barrie, Ontario, Canada
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Clinical Therapeutics Corp
🇺🇸Coral Gables, Florida, United States
Center for Clinical Trials of San Gabriel
🇺🇸West Covina, California, United States
Discover Research
🇺🇸Bryan, Texas, United States