Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes
1 other identifier
interventional
338
8 countries
176
Brief Summary
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Nov 2008
Typical duration for phase_2 diabetes-mellitus-type-2
176 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 13, 2009
CompletedFirst Posted
Study publicly available on registry
January 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedDecember 17, 2020
May 1, 2012
1.9 years
January 13, 2009
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (3)
Vildagliptin Dose 1
EXPERIMENTALVildagliptin Dose 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or lactating female
- FPG ≥ 270 mg/dL (≥15 mmol/L)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (176)
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
Unknown Facility
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
Midwest Pharmaceutical Research Inc.
City of Saint Peters, Missouri, 63376, United States
Midwest Pharmaceutical Research, Inc.
City of Saint Peters, Missouri, 63376, United States
Truman Medical Center & Univ Physician Associates
Kansas City, Missouri, 64108, United States
Ozark Mountains Medical Research
Ozark, Missouri, 65721, 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
Gopālapuram, 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, Malaysia
Hospital Putrajaya
Selangor Darul Ehsan, Selangor, 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
Ploieşti, Romania
Policlinica
Timișoara, Romania
Diabetologicka ambulancia
Komarnanska, Velky Meder, 932 01, Slovakia
Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia
Košice, 040 01, Slovakia
Diabetologicka ambulancia
Nové Mesto nad Váhom, 915 01, Slovakia
Diabetologicka ambulancia
Prešov, Slovakia
Mestska poliklinika Sered, Diabetologicka ambulancia
Sereď, 926 01, Slovakia
Diabetologicka ambulancia
Šahy, 936 01, Slovakia
Diabetologicka ambulancia
Trebišov, 075 01, Slovakia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2009
First Posted
January 14, 2009
Study Start
November 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
December 17, 2020
Record last verified: 2012-05