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Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Primary Purpose

Diabetes Mellitus, Type 2

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

  • History T2 DM
  • Severe Renal Impairment

Exclusion criteria

  • Glucose ≥ 270 mg/dL (≥15 mmol/L)
  • Patients undergoing any method of dialysis
  • Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides

Sites / Locations

  • University of South Alabama Medical Center
  • Anasazi Internal Medicine
  • University of Arkanasas for Medical Sciences
  • Office of William Zigrang
  • John Muir Clinical Research
  • Academic Medical Research Institute
  • UCLA Medical Center
  • Northern California Institute for Bone Health
  • Dr. Wei Feng
  • Sierra Clinical Research - Orangevale
  • 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
  • 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
  • Dolby Research, LLC
  • Metabolic Center of Louisiana
  • Bruce Samuels LLC
  • Crescent City Clinical Research Center
  • Egan Healthcare
  • Arthritis and Diabetes Clinic
  • Northwest Louisiana Nephrology Research
  • Joslin Diabetes Center at North Arundel Hospital
  • Biolab Research, LLC
  • Genesys Integrated Group Practice, PC
  • 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
  • Mayo Clinic Rochester
  • SUNY - Upstate Medical University
  • Meritcare Medical Group
  • Hightop Medical Research Center
  • University of Cincinnati
  • The Ohio State University Medical Center
  • Willamette Valley Clinical Studies
  • 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
  • Baylor Clinic (BCM 621)
  • Baylor College of Medicine
  • Allied Institute of Medicine
  • Central Utah Clinic
  • Clinical Research and Consulting Center, LLC
  • Medical College of Virginia
  • Medical College of Virginia
  • Washington State University at Spokane
  • UW Health - West

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vildagliptin

Sitagliptin

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment

Secondary Outcome Measures

Relationship between renal function and concentration levels of vildagliptin and its metabolites after repeated doses of vildagliptin in patients with T2DM and severe renal insufficiency.
Efficacy of vildagliptin versus sitagliptin in patients with T2DM and severe renal insufficiency by assessing the hemoglobin A1c (HbA1c ) and fasting plasma glucose (FPG) reduction from baseline

Full Information

First Posted
February 4, 2008
Last Updated
December 11, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00616811
Brief Title
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency
Official Title
A Multi-center, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With 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
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 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 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 24 weeks.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin
Arm Type
Experimental
Arm Title
Sitagliptin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Primary Outcome Measure Information:
Title
Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Relationship between renal function and concentration levels of vildagliptin and its metabolites after repeated doses of vildagliptin in patients with T2DM and severe renal insufficiency.
Time Frame
24 weekd
Title
Efficacy of vildagliptin versus sitagliptin in patients with T2DM and severe renal insufficiency by assessing the hemoglobin A1c (HbA1c ) and fasting plasma glucose (FPG) reduction from baseline
Time Frame
24 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 History T2 DM Severe Renal Impairment Exclusion criteria Glucose ≥ 270 mg/dL (≥15 mmol/L) Patients undergoing any method of dialysis Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals Corporation
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Anasazi Internal Medicine
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
University of Arkanasas for Medical Sciences
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Office of William Zigrang
City
Burlingame
State/Province
California
Country
United States
Facility Name
John Muir Clinical Research
City
Concord
State/Province
California
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
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
Country
United States
Facility Name
Sierra Clinical Research - Orangevale
City
Roseville
State/Province
California
Country
United States
Facility Name
Denver Nephrology PC
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Western Nephrology & Metabolic Bone Disease PC
City
Lakewood
State/Province
Colorado
Country
United States
Facility Name
Western Nephrology & Metabolic Bone Disease PC
City
Westminster
State/Province
Colorado
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Nephrology Associates of South Miami
City
Aventura
State/Province
Florida
Country
United States
Facility Name
University of Florida Shands Hospital
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Center for Diabetes & Endocrine Care
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Osler Medical Clinical Research
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
Tampa Bay Nephrology Associates
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Boise Kidney & Hypertension Institiute
City
Meridian
State/Province
Idaho
Country
United States
Facility Name
Iowa Diabetes & Endocrinology Research Center PLC
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Cray Diabetes Education Center
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Cotton-O'Neil Diabetes & Endocrinology Center
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Dolby Research, LLC
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Metabolic Center of Louisiana
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Bruce Samuels LLC
City
Covington
State/Province
Louisiana
Country
United States
Facility Name
Crescent City Clinical Research Center
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Egan Healthcare
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Arthritis and Diabetes Clinic
City
Monroe
State/Province
Louisiana
Country
United States
Facility Name
Northwest Louisiana Nephrology Research
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Joslin Diabetes Center at North Arundel Hospital
City
Glen Burnie
State/Province
Maryland
Country
United States
Facility Name
Biolab Research, LLC
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Genesys Integrated Group Practice, PC
City
Flint
State/Province
Michigan
Country
United States
Facility Name
Phillips Medical Services, PLLC
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Mississippi Medical Research, LLC
City
Picayune
State/Province
Mississippi
Country
United States
Facility Name
Diabetes and Endocrinology Specialist, Inc
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
Jefferson City Medical Group
City
Jefferson City
State/Province
Missouri
Country
United States
Facility Name
Arms, Dodge, Robinson, Wilber & Crouch, Inc.
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Washington U School of Medicine
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Platte Valley Medical Group
City
Kearney
State/Province
Nebraska
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Creighton Nephrology
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
UMDNJ-Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
University of New Mexico Health Science Center
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Downstate University of Brooklyn
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
HRRG
City
Orchard Park
State/Province
New York
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
New York
Country
United States
Facility Name
SUNY - Upstate Medical University
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Meritcare Medical Group
City
Fargo
State/Province
North Dakota
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Lehigh Valley Hospital-Dept. of Medicine Research
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Renal Endocrine Associates, P. C.
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Aiken Center for Clinical Research
City
Aiken
State/Province
South Carolina
Country
United States
Facility Name
Medical U of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
SC Nephrology and Hyptertension Center, Inc.
City
Orangeburg
State/Province
South Carolina
Country
United States
Facility Name
Sumter Medical Specialists
City
Sumter
State/Province
South Carolina
Country
United States
Facility Name
AM Diabetes and Endocrinology Center
City
Bartlett
State/Province
Tennessee
Country
United States
Facility Name
Medical Nephrology Associates
City
Dyersburg
State/Province
Tennessee
Country
United States
Facility Name
Dallas Diabetes & Endocrine Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Texas Tech University Health Sciences
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Baylor Clinic (BCM 621)
City
Houston
State/Province
Texas
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
Allied Institute of Medicine
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Central Utah Clinic
City
American Fork
State/Province
Utah
Country
United States
Facility Name
Clinical Research and Consulting Center, LLC
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Medical College of Virginia
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Washington State University at Spokane
City
Spokane
State/Province
Washington
Country
United States
Facility Name
UW Health - West
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26067186
Citation
Kothny W, Lukashevich V, Foley JE, Rendell MS, Schweizer A. Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment: a randomised clinical trial. Diabetologia. 2015 Sep;58(9):2020-6. doi: 10.1007/s00125-015-3655-z. Epub 2015 Jun 12.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4599
Description
Results for CLAF237A23138 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

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