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Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

Primary Purpose

Diabetes Mellitus, Type 2, Renal Insufficiency

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
vildagliptin
sitagliptin
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 - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complete the core study and consent for extension

Exclusion Criteria:

  • Patient unable to comply with core study requirements

Sites / Locations

  • University of South Alabama Medical Center
  • Anasazi Internal Medicine
  • Sonoran Health Specialists
  • Mary K. Richards, MD. PA
  • University of Arkanasas for Medical Sciences
  • John Muir Clinical Research
  • Academic Medical Research Institute
  • UCLA Medical Center
  • Northern California Institute for Bone Health
  • Dr. Wei Feng
  • Sierra Clinical Research - Orangevale
  • California Institute of Renal Research
  • Denver Nephrology PC
  • Western Nephrology & Metabolic Bone Disease PC
  • Western Nephrology & Metabolic Bone Disease PC
  • Hartford Hospital
  • Nephrology Associates of South Miami
  • University of Florida Shands Hospital
  • Center for Diabetes & Endocrine Care
  • Larry Levinson, D.O., PA
  • Jacksonville Center for Clinical Research
  • Osler Medical Clinical Research
  • Tampa Bay Nephrology Associates
  • Atlanta Diabetes Associates
  • Emory Clinic
  • University of Hawaii
  • Boise Kidney & Hypertension Institiute
  • Iowa Diabetes & Endocrinology Research Center PLC
  • University of Iowa
  • Cray Diabetes Education Center
  • Cotton-O'Neil Diabetes & Endocrinology Center
  • Metabolic Center of Louisiana
  • Dolby Research, LLC
  • Bruce Samuels LLC
  • Egan Healthcare
  • Crescent City Clinical Research Center
  • Arthritis and Diabetes Clinic
  • Northwest Louisiana Nephrology Research
  • Joslin Diabetes Center at North Arundel Hospital
  • Biolab Research, LLC
  • Harvard University (Joslin Diabetes Center)
  • Genesys Integrated Group Practice, PC
  • Mayo Clinic Rochester
  • Phillips Medical Services, PLLC
  • Mississippi Medical Research, LLC
  • Diabetes and Endocrinology Specialist, Inc
  • Jefferson City Medical Group
  • Arms, Dodge, Robinson, Wilber & Crouch, Inc.
  • Washington U School of Medicine
  • Platte Valley Medical Group
  • Creighton Diabetes Center
  • Creighton Nephrology
  • UMDNJ-Robert Wood Johnson
  • University of New Mexico Health Science Center
  • Downstate University of Brooklyn
  • HRRG
  • SUNY - Upstate Medical University
  • Meritcare Medical Group
  • University of Cincinnati
  • Hightop Medical Research Center
  • The Ohio State University Medical Center
  • Willamette Valley Clinical Studies
  • Portland Hypertension and Nephrology
  • Lehigh Valley Hospital-Dept. of Medicine Research
  • Thomas Jefferson University Hospital
  • Renal Endocrine Associates, P. C.
  • Aiken Center for Clinical Research
  • Medical U of South Carolina
  • SC Nephrology and Hyptertension Center, Inc.
  • Sumter Medical Specialists
  • AM Diabetes and Endocrinology Center
  • Medical Nephrology Associates
  • Dallas Diabetes & Endocrine Center
  • North Texas Endocrine Center
  • Texas Tech University Health Sciences Center
  • Baylor Clinic (BCM 621)
  • Baylor College of Medicine
  • Renal Associates, P.A.
  • Allied Institute of Medicine
  • Central Utah Clinic
  • Clinical Research and Consulting Center, LLC
  • Nephrology Associates of Northern Virginia
  • Medical College of Virginia
  • Medical College of Virginia
  • Washington State University at Spokane
  • UW Health - West Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

50mg qd vildagliptin

sitagliptin (25mg qd)

Outcomes

Primary Outcome Measures

Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest)

Secondary Outcome Measures

To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment

Full Information

First Posted
October 8, 2008
Last Updated
December 11, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00770081
Brief Title
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)
Official Title
A 28-week Extension to a 24-week Multicenter, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Renal Insufficiency
Keywords
Type 2 diabetes, vildagliptin

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
50mg qd vildagliptin
Arm Title
2
Arm Type
Active Comparator
Arm Description
sitagliptin (25mg qd)
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Intervention Description
50mg qd
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
25mg qd
Primary Outcome Measure Information:
Title
Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complete the core study and consent for extension Exclusion Criteria: Patient unable to comply with core study requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Anasazi Internal Medicine
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Sonoran Health Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Mary K. Richards, MD. PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
University of Arkanasas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
John Muir Clinical Research
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Northern California Institute for Bone Health
City
Oakland
State/Province
California
Country
United States
Facility Name
Dr. Wei Feng
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
Facility Name
Sierra Clinical Research - Orangevale
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
California Institute of Renal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Denver Nephrology PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Western Nephrology & Metabolic Bone Disease PC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80214
Country
United States
Facility Name
Western Nephrology & Metabolic Bone Disease PC
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Nephrology Associates of South Miami
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
University of Florida Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Center for Diabetes & Endocrine Care
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Larry Levinson, D.O., PA
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Osler Medical Clinical Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Tampa Bay Nephrology Associates
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Boise Kidney & Hypertension Institiute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Iowa Diabetes & Endocrinology Research Center PLC
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Cray Diabetes Education Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cotton-O'Neil Diabetes & Endocrinology Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Metabolic Center of Louisiana
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
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
Egan Healthcare
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Crescent City Clinical Research Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Arthritis and Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Northwest Louisiana Nephrology Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101-4440
Country
United States
Facility Name
Joslin Diabetes Center at North Arundel Hospital
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Biolab Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852-1542
Country
United States
Facility Name
Harvard University (Joslin Diabetes Center)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Genesys Integrated Group Practice, PC
City
Flint
State/Province
Michigan
ZIP/Postal Code
49532
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Phillips Medical Services, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39209
Country
United States
Facility Name
Mississippi Medical Research, LLC
City
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
Country
United States
Facility Name
Diabetes and Endocrinology Specialist, Inc
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Jefferson City Medical Group
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Arms, Dodge, Robinson, Wilber & Crouch, Inc.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington U School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Platte Valley Medical Group
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68848
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Creighton Nephrology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
UMDNJ-Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University of New Mexico Health Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Downstate University of Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203-2056
Country
United States
Facility Name
HRRG
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
SUNY - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Meritcare Medical Group
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Portland Hypertension and Nephrology
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
Country
United States
Facility Name
Lehigh Valley Hospital-Dept. of Medicine Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Renal Endocrine Associates, P. C.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Aiken Center for Clinical Research
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29801
Country
United States
Facility Name
Medical U of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
SC Nephrology and Hyptertension Center, Inc.
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29115
Country
United States
Facility Name
Sumter Medical Specialists
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
AM Diabetes and Endocrinology Center
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Medical Nephrology Associates
City
Dyersburg
State/Province
Tennessee
ZIP/Postal Code
38024
Country
United States
Facility Name
Dallas Diabetes & Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Baylor Clinic (BCM 621)
City
Houston
State/Province
Texas
ZIP/Postal Code
770303411
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Renal Associates, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Allied Institute of Medicine
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78222
Country
United States
Facility Name
Central Utah Clinic
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Clinical Research and Consulting Center, LLC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Nephrology Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0111
Country
United States
Facility Name
Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Washington State University at Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
UW Health - West Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5923
Description
Results for CLAF237A23138E1 from the Novartis Clinical Trials website

Learn more about this trial

Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

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