Clinical trial NCT00821977: Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks.
timeFrame: 24 weeks
Secondary outcomes:
measure: 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
timeFrame: 24 weeks
measure: Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM
timeFrame: 24 weeks
measure: Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM
timeFrame: 76 weeks
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Pell City
country: United States
facility: Advanced Clinical Research
state: Alabama
city: Gilbert
country: United States
facility: Horizon Clinical Research Associates, PLLC
state: Arizona
city: Mesa
country: United States
facility: Vista Medical Research, Inc
state: Arizona
city: Mesa
country: United States
facility: Clinical Research Advantage
state: Arizona
city: Phoenix
country: United States
facility: Hope Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Anasazi Internal Medicine
state: Arizona
city: Phoenix
country: United States
facility: Tatum Ridge Internal Medicine
state: Arizona
city: Tucson
country: United States
facility: Paradigm Clinical
state: Arizona
city: Tucson
country: United States
facility: Tucson Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Medical Investigations, Inc.
state: Arkansas
city: Pine Bluff
country: United States
facility: Paul W. Davis, MD
state: Arkansas
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research
state: California
city: Burbank
country: United States
facility: Providence Research
state: California
city: Burbank
country: United States
facility: Burbank - Lovelace Scientific Resources, Inc.
state: California
city: Norwalk
country: United States
facility: Lucita M. Cruz, M.D., Inc.
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Diego
country: United States
facility: Ritchken and First MDs
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine Research and Family Care
state: California
city: Santa Ana
country: United States
facility: Crest Clinical Trials
state: California
city: Santa Ana
country: United States
facility: NuLife Clinical Research, Inc.
state: California
city: Santa Monica
country: United States
facility: Westside Arthritis and Metabolism Center
state: California
city: West Covina
country: United States
facility: Center for Clinical Trials of San Gabriel
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Health Partners, Pc
state: Colorado
city: Colorado Springs
country: United States
facility: Express Care Clinical Research
state: Colorado
city: Denver
country: United States
facility: Cherry Creek Family Practice
state: Colorado
city: Littleton
country: United States
facility: Metro Clinical Research
state: Colorado
city: Northglenn
country: United States
facility: Complete Family Care
state: Colorado
city: Coral Gables
country: United States
facility: Clinical Therapeutics Corp
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Miramar
country: United States
facility: South Florida Clinical Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Research, LLC
state: Florida
city: South Miami
country: United States
facility: Well Pharma Medical Research
state: Florida
city: Augusta
country: United States
facility: Southern Clinical Research
state: Georgia
city: Conyers
country: United States
facility: Rockdale Medical Research
state: Georgia
city: Ellijay
country: United States
facility: North Georgia Medical Research Institute
state: Georgia
city: Roswell
country: United States
facility: Perimeter North Medical Research
state: Georgia
city: Alton
country: United States
facility: JMG CIinical Research
state: Illinois
city: Aurora
country: United States
facility: Fox Valley Clinical Research
state: Illinois
city: Indianapolis
country: United States
facility: American Health Network
state: Indiana
city: Mason City
country: United States
facility: Mercy Family Medicine
state: Iowa
city: Lansing
country: United States
facility: Associates Research, Inc
state: Kansas
city: Pratt
country: United States
facility: Health Science Research Center
state: Kansas
city: Topeka
country: United States
facility: Cotton O'neil Clinic
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Baton Rouge
country: United States
facility: Dolby Research, LLC
state: Louisiana
city: Covington
country: United States
facility: Bruce Samuels LLC
state: Louisiana
city: Lafayette
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Metairie
country: United States
facility: Crescent City Clinical Research Center
state: Louisiana
city: Shreveport
country: United States
facility: The Family Doctors
state: Louisiana
city: Scarborough
country: United States
facility: Maine Centers for Endocrinology & Diabetes
state: Maine
city: Chelsea
country: United States
facility: Michigan Hypertension Center
state: Michigan
city: Flint
country: United States
facility: Genesys Integrated Group Practice, PC
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Heart Institute-Borgess Research Institute
state: Michigan
city: Petoskey
country: United States
facility: NISUS Research Northern MI Hospital
state: Michigan
city: Pinckney
country: United States
facility: Spence Medical Research Center, LLC
state: Michigan
city: Stevensville
country: United States
facility: Southwestern Medical Clinic, PC
state: Michigan
city: Belzoni
country: United States
facility: Belzoni Clinical Research
state: Mississippi
city: Gulfport
country: United States
facility: Gulfside Clinical Research
state: Mississippi
city: Picayune
country: United States
facility: Mississippi Medical Research, LLC
state: Mississippi
city: Chesterfield
country: United States
facility: Woodlake Research
state: Missouri
city: Kansas City
country: United States
facility: Truman Medical Center & Univ Physician Associates
state: Missouri
city: Ozark
country: United States
facility: Ozark Mountains Medical Research
state: Missouri
city: Saint Peters
country: United States
facility: Midwest Pharmaceutical Research Inc.
state: Missouri
city: Saint Peters
country: United States
facility: Midwest Pharmaceutical Research, Inc.
state: Missouri
city: Springfield
country: United States
facility: Ozark Medical-Surgical Associates, Ltd.
state: Missouri
city: Springfield
country: United States
facility: ClinVest Research
state: Missouri
city: Washington
country: United States
facility: Patient's First Health Care
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration
state: Nebraska
city: Lincoln
country: United States
facility: Fallbrook Family Health Center
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Henderson
country: United States
facility: Desert Endocrinology Clinical Research Center
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Center of NV
state: Nevada
city: Las Vegas
country: United States
facility: Palm Medical Research Center
state: Nevada
city: Nashua
country: United States
facility: Joslin Diabetes Center
state: New Hampshire
city: Toms River
country: United States
facility: Shore Health Group
state: New Jersey
city: Toms River
country: United States
facility: Physicians Research Center
state: New Jersey
city: Albany
country: United States
facility: The Endocrine Group, LLP
state: New York
city: Endwell
country: United States
facility: Endwell Family Physician
state: New York
city: New Hyde Park
country: United States
facility: North Shore Diabetes and Endocrine Associates
state: New York
city: New York
country: United States
facility: Mezitis Education & Research Institute
state: New York
city: Burlington
country: United States
facility: Cornerstone Medical Center
state: North Carolina
city: Burlington
country: United States
facility: Kernodle Clinic, Inc.
state: North Carolina
city: Charlotte
country: United States
facility: Neem Research Group of Charlotte
state: North Carolina
city: Greensboro
country: United States
facility: Bland Clinic, PA
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Private Practice
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Shelby
country: United States
facility: Jones Family Practice, PA
state: North Carolina
city: Statesville
country: United States
facility: The Lipid Center
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Marion
country: United States
facility: Frederick C. Smith Clinic R & R Research
state: Ohio
city: Zanesville
country: United States
facility: Pharmacotherapy Research Associates, INC
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Norman
country: United States
facility: Lion Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Integris Physicians Services Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Memorial Clinical Research
state: Oklahoma
city: Altoona
country: United States
facility: Blair Medical Associates Inc
state: Pennsylvania
city: Beaver
country: United States
facility: Tri-State Medical Group
state: Pennsylvania
city: Fleetwood
country: United States
facility: Fleetwood Medical Associates
state: Pennsylvania
city: Levittown
country: United States
facility: Family Medical Associates
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Anderson
country: United States
facility: Hartwell Research Group, LLC
state: South Carolina
city: Charleston
country: United States
facility: Low Country Internal Medicine
state: South Carolina
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials, INC
state: South Carolina
city: Clinton
country: United States
facility: The Family Healthcare Center
state: South Carolina
city: Columbia
country: United States
facility: Columbia Clinical Research
state: South Carolina
city: Garden City
country: United States
facility: Med Plus South - Strand Family Practice
state: South Carolina
city: Greer
country: United States
facility: DeGarmo Institute of Medical Research
state: South Carolina
city: Summerville
country: United States
facility: Dorchester Medical Associates
state: South Carolina
city: Taylors
country: United States
facility: Southeastern Research Associates, Inc.
state: South Carolina
city: Varnville
country: United States
facility: Community Research Partners, Inc.
state: South Carolina
city: Bartlett
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: Bristol
country: United States
facility: Tri-Cities Medical Research
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Addison
country: United States
facility: ACRC Trials
state: Texas
city: Beaumont
country: United States
facility: Discover Research Inc.
state: Texas
city: Beaumont
country: United States
facility: MW Clinical Research
state: Texas
city: Bryan
country: United States
facility: Discover Research
state: Texas
city: Dallas
country: United States
facility: Z&Z Medical Associates/Internal Medicine Clinical Research
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Houston
country: United States
facility: HCA Research
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, P.A.
state: Texas
city: Irving
country: United States
facility: Leading Edge Research, PA
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: McAllen
country: United States
facility: South Texas Institutes of Health
state: Texas
city: New Braunfels
country: United States
facility: Hill Country Medical Associates
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Family Practice
state: Texas
city: Odessa
country: United States
facility: Naidu Clinic
state: Texas
city: Pasadena
country: United States
facility: Med-Olam Clinical Research
state: Texas
city: Pearland
country: United States
facility: Southwest Clinical Research Centers, LLC
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic , PA
state: Texas
city: Bountiful
country: United States
facility: Progressive Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Utah Clinical Trials
state: Utah
city: South Burlington
country: United States
facility: Diabetes Research Center
state: Vermont
city: Northport
country: United States
facility: Northport VA Medical Center
state: Virginia
city: Weber City
country: United States
facility: Holston Medical Group
state: Virginia
city: Bellingham
country: United States
facility: Madrona Medical Group - Clinical Research Dept.
state: Washington
city: Seattle
country: United States
facility: Summit Reserach Network, LLC
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Moncton
country: Canada
facility: G.A. Research Associates Moncton, New Brunswick E1G 1 A7
state: New Brunswick
city: Carbonear
country: Canada
facility: T.C. Health Center
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: LMC Endocrinology Centres (Barrie) Ltd.
state: Ontario
city: Etobicoke
country: Canada
facility: LMC Endocrinology Centres -(Etobicoke) Ltd. ,
state: Ontario
city: Thornhill
country: Canada
facility: LMC Endocrinology Centres -(Thornhill)
state: Ontario
city: Toronto
country: Canada
facility: LMC Endocrinology Centres (Toronto) Ltd.
state: Ontario
city: Gopalapuram
country: India
facility: Madras Diabetes Research Foundation
state: Chennai
city: Hyderabaad
country: India
facility: Medicity Hospital
state: Hyderabad
city: Bangalore
country: India
facility: Manipal Hospital
city: Chennai
country: India
facility: MV Hospital for Diabetes and Diabetes Research Centre
city: Indore
country: India
facility: Diabetes Thyroid Hormone Research Institute Pvt Ltd.
city: Vellore
country: India
facility: Christian Medical College
city: Selangor Darul Ehsan
country: Malaysia
facility: University Malaya Medical Centre
state: Ehsan
city: Kuala Lumpur
country: Malaysia
facility: Hospital University Kebangsaan Malaysia
state: Selangor Darul Ehsan
city: Selangor Darul Ehsan
country: Malaysia
facility: Hospital Putrajaya
city: Sta Cruz
country: Philippines
facility: Jose R. Reyes Memorial Medical Center
state: Manila
city: Manila
country: Philippines
facility: Metropolitan Medical Center
city: Marikina City
country: Philippines
facility: Institute for Studies on Diabetes Foundation
city: Carolina
country: Puerto Rico
facility: Policlinica Dr. Luis Rodriguez Carrasquillo
city: Levittown
country: Puerto Rico
facility: Yolanda Sierra Medical Office
city: Ponce
country: Puerto Rico
facility: Endocrine Lipid Diabetes Research Institute
city: San Juan
country: Puerto Rico
facility: Centro Clinico San Patricio
city: San Juan
country: Puerto Rico
facility: Miguel Sosa-Padilla, M.D.
city: Baia Mare
country: Romania
facility: CMI Cardiologie
city: Bucharest
country: Romania
facility: Paulescu Institute
city: Oradea
country: Romania
facility: Anamed SRL
city: Ploiesti
country: Romania
facility: Emergency County Hospital Ploiesti
city: Timisoara
country: Romania
facility: Policlinica
city: Komarnanska
country: Slovakia
facility: Diabetologicka ambulancia
state: Velky Meder
city: Kosice
country: Slovakia
facility: Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia
city: Nove Mesto nad Vahom
country: Slovakia
facility: Diabetologicka ambulancia
city: Presov
country: Slovakia
facility: Diabetologicka ambulancia
city: Sahy
country: Slovakia
facility: Diabetologicka ambulancia
city: Sered
country: Slovakia
facility: Mestska poliklinika Sered, Diabetologicka ambulancia
city: Trebisov
country: Slovakia
facility: Diabetologicka ambulancia
Study officials:
References: