Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

December 11, 2020 updated by: Novartis
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: Vildagliptin Dose 1
Drug: Vildagliptin
EXPERIMENTAL: Vildagliptin Dose 2
Drug: Vildagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 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
Time Frame: 24 weeks
24 weeks
Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM
Time Frame: 76 weeks
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
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (ESTIMATE)

January 14, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237B2201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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