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

December 11, 2020 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • 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

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • University of South Alabama Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Anasazi Internal Medicine
      • Scottsdale, Arizona, United States, 85260
        • Sonoran Health Specialists
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Mary K. Richards, MD. PA
      • Little Rock, Arkansas, United States, 72205
        • University of Arkanasas for Medical Sciences
    • California
      • Burlingame, California, United States, 94010
      • Concord, California, United States, 94520
        • John Muir Clinical Research
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Oakland, California, United States
        • Northern California Institute for Bone Health
      • Pasadena, California, United States, 91101
        • Dr. Wei Feng
      • Roseville, California, United States, 95661
        • Sierra Clinical Research - Orangevale
      • San Diego, California, United States, 92123
        • California Institute of Renal Research
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Nephrology PC
      • Lakewood, Colorado, United States, 80214
        • Western Nephrology & Metabolic Bone Disease PC
      • Westminster, Colorado, United States, 80031
        • Western Nephrology & Metabolic Bone Disease PC
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Aventura, Florida, United States, 33180
        • Nephrology Associates of South Miami
      • Gainesville, Florida, United States, 32610
        • University of Florida Shands Hospital
      • Hollywood, Florida, United States, 33021
        • Center for Diabetes & Endocrine Care
      • Hollywood, Florida, United States, 33021
        • Larry Levinson, D.O., PA
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Melbourne, Florida, United States, 32901
        • Osler Medical Clinical Research
      • Tampa, Florida, United States, 33603
        • Tampa Bay Nephrology Associates
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic
      • Atlanta, Georgia, United States, 30309
        • Atlanta Diabetes Associates
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Boise Kidney & Hypertension Institiute
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Diabetes & Endocrinology Research Center PLC
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Cray Diabetes Education Center
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Diabetes & Endocrinology Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Dolby Research, LLC
      • Baton Rouge, Louisiana, United States, 70808
        • Metabolic Center of Louisiana
      • Covington, Louisiana, United States, 70433
        • Bruce Samuels LLC
      • Metairie, Louisiana, United States, 70006
        • Crescent City Clinical Research Center
      • Metairie, Louisiana, United States, 70002
        • Egan Healthcare
      • Monroe, Louisiana, United States, 71203
        • Arthritis and Diabetes Clinic
      • Shreveport, Louisiana, United States, 71101-4440
        • Northwest Louisiana Nephrology Research
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Joslin Diabetes Center at North Arundel Hospital
      • Rockville, Maryland, United States, 20852-1542
        • Biolab Research, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Harvard University (Joslin Diabetes Center)
    • Michigan
      • Flint, Michigan, United States, 49532
        • Genesys Integrated Group Practice, PC
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Mississippi
      • Jackson, Mississippi, United States, 39209
        • Phillips Medical Services, PLLC
      • Picayune, Mississippi, United States, 39466
        • Mississippi Medical Research, LLC
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Diabetes and Endocrinology Specialist, Inc
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group
      • Kansas City, Missouri, United States, 64111
        • Arms, Dodge, Robinson, Wilber & Crouch, Inc.
      • Saint Louis, Missouri, United States, 63110
        • Washington U School of Medicine
    • Nebraska
      • Kearney, Nebraska, United States, 68848
        • Platte Valley Medical Group
      • Omaha, Nebraska, United States, 68131
        • Creighton Diabetes Center
      • Omaha, Nebraska, United States, 68131
        • Creighton Nephrology
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • UMDNJ-Robert Wood Johnson
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Science Center
    • New York
      • Brooklyn, New York, United States, 11203-2056
        • Downstate University of Brooklyn
      • Orchard Park, New York, United States, 14127
        • HRRG
      • Syracuse, New York, United States, 13210
        • SUNY - Upstate Medical University
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • MeritCare Medical Group
    • Ohio
      • Cincinnati, Ohio, United States, 45224
        • Hightop Medical Research Center
      • Cincinnati, Ohio, United States, 45206
        • University of Cincinnati
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Willamette Valley Clinical Studies
      • Oregon City, Oregon, United States, 97045
        • Portland Hypertension and Nephrology
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Hospital-Dept. of Medicine Research
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15224
        • Renal Endocrine Associates, P. C.
    • South Carolina
      • Aiken, South Carolina, United States, 29801
        • Aiken Center for Clinical Research
      • Charleston, South Carolina, United States, 29425
        • Medical U of South Carolina
      • Orangeburg, South Carolina, United States, 29115
        • SC Nephrology and Hyptertension Center, Inc.
      • Sumter, South Carolina, United States, 29150
        • Sumter Medical Specialists
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • AM Diabetes And Endocrinology Center
      • Dyersburg, Tennessee, United States, 38024
        • Medical Nephrology Associates
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes & Endocrine Center
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 770303411
        • Baylor Clinic (BCM 621)
      • San Antonio, Texas, United States, 78215
        • Renal Associates, P.A.
      • San Antonio, Texas, United States, 78222
        • Allied Institute of Medicine
    • Utah
      • American Fork, Utah, United States, 84003
        • Central Utah Clinic
    • Virginia
      • Fairfax, Virginia, United States, 22033
        • Nephrology Associates Of Northern Virginia
      • Fairfax, Virginia, United States, 22030
        • Clinical Research and Consulting Center, LLC
      • Richmond, Virginia, United States, 23298
        • Medical College of Virginia
      • Richmond, Virginia, United States, 23298-0111
        • Medical College of Virginia
    • Washington
      • Spokane, Washington, United States, 99202
        • Washington State University at Spokane
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • UW Health - West Clinic

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 to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complete the core study and consent for extension

Exclusion Criteria:

  • Patient unable to comply with core study requirements

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
EXPERIMENTAL: 1
50mg qd vildagliptin
Drug: vildagliptin
50mg qd
ACTIVE_COMPARATOR: 2
sitagliptin (25mg qd)
Drug: sitagliptin
25mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest)
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

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

September 1, 2008

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 8, 2008

First Posted (ESTIMATE)

October 9, 2008

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

  • CLAF237A23138E1

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on vildagliptin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe