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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vildagliptin
Vildagliptin
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 Diabetes, Vildagliptin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advanced Clinical Research
  • Horizon Clinical Research Associates, PLLC
  • Vista Medical Research, Inc
  • Clinical Research Advantage
  • Hope Clinical Research
  • Anasazi Internal Medicine
  • Tatum Ridge Internal Medicine
  • Paradigm Clinical
  • Tucson Clinical Research
  • Medical Investigations, Inc.
  • Paul W. Davis, MD
  • Sall Research Medical Center
  • Associated Pharmaceutical Research
  • Providence Research
  • Burbank - Lovelace Scientific Resources, Inc.
  • Lucita M. Cruz, M.D., Inc.
  • California Research Foundation
  • Ritchken and First MDs
  • San Diego Sports Medicine Research and Family Care
  • Crest Clinical Trials
  • NuLife Clinical Research, Inc.
  • Westside Arthritis and Metabolism Center
  • Center for Clinical Trials of San Gabriel
  • Colorado Springs Health Partners, Pc
  • Express Care Clinical Research
  • Cherry Creek Family Practice
  • Metro Clinical Research
  • Complete Family Care
  • Clinical Therapeutics Corp
  • South Florida Clinical Research Center
  • Pines Research, LLC
  • Well Pharma Medical Research
  • Southern Clinical Research
  • Rockdale Medical Research
  • North Georgia Medical Research Institute
  • Perimeter North Medical Research
  • JMG CIinical Research
  • Fox Valley Clinical Research
  • American Health Network
  • Mercy Family Medicine
  • Associates Research, Inc
  • Health Science Research Center
  • Cotton O'neil Clinic
  • Heartland Research Associates, LLC
  • Dolby Research, LLC
  • Bruce Samuels LLC
  • Gulf Coast Research, LLC
  • Crescent City Clinical Research Center
  • The Family Doctors
  • Maine Centers for Endocrinology & Diabetes
  • Michigan Hypertension Center
  • Genesys Integrated Group Practice, PC
  • Borgess Heart Institute-Borgess Research Institute
  • NISUS Research Northern MI Hospital
  • Spence Medical Research Center, LLC
  • Southwestern Medical Clinic, PC
  • Belzoni Clinical Research
  • Gulfside Clinical Research
  • Mississippi Medical Research, LLC
  • Woodlake Research
  • Truman Medical Center & Univ Physician Associates
  • Ozark Mountains Medical Research
  • Midwest Pharmaceutical Research Inc.
  • Midwest Pharmaceutical Research, Inc.
  • Ozark Medical-Surgical Associates, Ltd.
  • ClinVest Research
  • Patient's First Health Care
  • Physician Research Collaboration
  • Fallbrook Family Health Center
  • Quality Clinical Research
  • Heartland Clinical Research, Inc.
  • Desert Endocrinology Clinical Research Center
  • Clinical Research Center of NV
  • Palm Medical Research Center
  • Joslin Diabetes Center
  • Shore Health Group
  • Physicians Research Center
  • The Endocrine Group, LLP
  • Endwell Family Physician
  • North Shore Diabetes and Endocrine Associates
  • Mezitis Education & Research Institute
  • Cornerstone Medical Center
  • Kernodle Clinic, Inc.
  • Neem Research Group of Charlotte
  • Bland Clinic, PA
  • Triad Clinical Trials, LLC
  • Private Practice
  • Crescent Medical Research
  • Jones Family Practice, PA
  • The Lipid Center
  • Lillestol Research, LLC
  • Frederick C. Smith Clinic R & R Research
  • Pharmacotherapy Research Associates, INC
  • Central Sooner Research
  • Lion Research
  • Integris Physicians Services Clinical Research
  • Memorial Clinical Research
  • Blair Medical Associates Inc
  • Tri-State Medical Group
  • Fleetwood Medical Associates
  • Family Medical Associates
  • New England Center for Clinical Research
  • Hartwell Research Group, LLC
  • Low Country Internal Medicine
  • Pharmacorp Clinical Trials, INC
  • The Family Healthcare Center
  • Columbia Clinical Research
  • Med Plus South - Strand Family Practice
  • DeGarmo Institute of Medical Research
  • Dorchester Medical Associates
  • Southeastern Research Associates, Inc.
  • Community Research Partners, Inc.
  • AM Diabetes and Endocrinology Center
  • Tri-Cities Medical Research
  • Holston Medical Group
  • ACRC Trials
  • Discover Research Inc.
  • MW Clinical Research
  • Discover Research
  • Z&Z Medical Associates/Internal Medicine Clinical Research
  • Western Sky Medical Research
  • HCA Research
  • Texas Center for Drug Development, P.A.
  • Leading Edge Research, PA
  • R/D Clinical Research, Inc.
  • South Texas Institutes of Health
  • Hill Country Medical Associates
  • North Hills Family Practice
  • Naidu Clinic
  • Med-Olam Clinical Research
  • Southwest Clinical Research Centers, LLC
  • Diabetes & Glandular Disease Clinic , PA
  • Progressive Clinical Research
  • Utah Clinical Trials
  • Diabetes Research Center
  • Northport VA Medical Center
  • Holston Medical Group
  • Madrona Medical Group - Clinical Research Dept.
  • Summit Reserach Network, LLC
  • Madigan Army Medical Center
  • G.A. Research Associates Moncton, New Brunswick E1G 1 A7
  • T.C. Health Center
  • LMC Endocrinology Centres (Barrie) Ltd.
  • LMC Endocrinology Centres -(Etobicoke) Ltd. ,
  • LMC Endocrinology Centres -(Thornhill)
  • LMC Endocrinology Centres (Toronto) Ltd.
  • Madras Diabetes Research Foundation
  • Medicity Hospital
  • Manipal Hospital
  • MV Hospital for Diabetes and Diabetes Research Centre
  • Diabetes Thyroid Hormone Research Institute Pvt Ltd.
  • Christian Medical College
  • University Malaya Medical Centre
  • Hospital University Kebangsaan Malaysia
  • Hospital Putrajaya
  • Jose R. Reyes Memorial Medical Center
  • Metropolitan Medical Center
  • Institute for Studies on Diabetes Foundation
  • Policlinica Dr. Luis Rodriguez Carrasquillo
  • Yolanda Sierra Medical Office
  • Endocrine Lipid Diabetes Research Institute
  • Centro Clinico San Patricio
  • Miguel Sosa-Padilla, M.D.
  • CMI Cardiologie
  • Paulescu Institute
  • Anamed SRL
  • Emergency County Hospital Ploiesti
  • Policlinica
  • Diabetologicka ambulancia
  • Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia
  • Diabetologicka ambulancia
  • Diabetologicka ambulancia
  • Diabetologicka ambulancia
  • Mestska poliklinika Sered, Diabetologicka ambulancia
  • Diabetologicka ambulancia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Vildagliptin Dose 1

Vildagliptin Dose 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM
Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM
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

Full Information

First Posted
January 13, 2009
Last Updated
December 11, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00821977
Brief Title
Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 Diabetes, Vildagliptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin Dose 1
Arm Type
Experimental
Arm Title
Vildagliptin Dose 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4586
Description
Results for CLAF237B2201 from the Novartis Clinical Trials website

Learn more about this trial

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

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