AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT00770081

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

A Phase 3 study testing vildagliptin and sitagliptin in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, run by Novartis at 87 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
vildagliptin and sitagliptin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
87 sitesUnited States
Study dates
Sep 2008to Apr 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Complete the core study and consent for extension

Who cannot join

  • Patient unable to comply with core study requirements

Trial locations and contacts

87 sites in 1 country.

87 sites in 1 country

United States87 sites

  • Aiken Center for Clinical Research

    Aiken, South Carolina, 29801

  • University of New Mexico Health Science Center

    Albuquerque, New Mexico, 87131

  • Lehigh Valley Hospital-Dept. of Medicine Research

    Allentown, Pennsylvania, 18105

  • Central Utah Clinic

    American Fork, Utah, 84003

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30309

  • Emory Clinic

    Atlanta, Georgia, 30322

  • Nephrology Associates of South Miami

    Aventura, Florida, 33180

  • AM Diabetes and Endocrinology Center

    Bartlett, Tennessee, 38133

  • Metabolic Center of Louisiana

    Baton Rouge, Louisiana, 70808

  • Dolby Research, LLC

    Baton Rouge, Louisiana, 70809

  • Harvard University (Joslin Diabetes Center)

    Boston, Massachusetts, 02215

  • Downstate University of Brooklyn

    Brooklyn, New York, 11203-2056

  • Study site

    Burlingame, California, 94010

  • Medical U of South Carolina

    Charleston, South Carolina, 29425

  • Diabetes and Endocrinology Specialist, Inc

    Chesterfield, Missouri, 63017

  • University of Cincinnati

    Cincinnati, Ohio, 45206

  • Hightop Medical Research Center

    Cincinnati, Ohio, 45224

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • John Muir Clinical Research

    Concord, California, 94520

  • Bruce Samuels LLC

    Covington, Louisiana, 70433

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Denver Nephrology PC

    Denver, Colorado, 80230

  • Iowa Diabetes & Endocrinology Research Center PLC

    Des Moines, Iowa, 50314

  • Medical Nephrology Associates

    Dyersburg, Tennessee, 38024

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905

  • Willamette Valley Clinical Studies

    Eugene, Oregon, 97404

  • Clinical Research and Consulting Center, LLC

    Fairfax, Virginia, 22030

  • Nephrology Associates of Northern Virginia

    Fairfax, Virginia, 22033

  • Meritcare Medical Group

    Fargo, North Dakota, 58122

  • Genesys Integrated Group Practice, PC

    Flint, Michigan, 49532

  • University of Florida Shands Hospital

    Gainesville, Florida, 32610

  • Joslin Diabetes Center at North Arundel Hospital

    Glen Burnie, Maryland, 21061

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Center for Diabetes & Endocrine Care

    Hollywood, Florida, 33021

  • Larry Levinson, D.O., PA

    Hollywood, Florida, 33021

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Baylor Clinic (BCM 621)

    Houston, Texas, 770303411

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • Phillips Medical Services, PLLC

    Jackson, Mississippi, 39209

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109

  • Cray Diabetes Education Center

    Kansas City, Kansas, 66160

  • Arms, Dodge, Robinson, Wilber & Crouch, Inc.

    Kansas City, Missouri, 64111

  • Platte Valley Medical Group

    Kearney, Nebraska, 68848

  • Western Nephrology & Metabolic Bone Disease PC

    Lakewood, Colorado, 80214

  • Mary K. Richards, MD. PA

    Little Rock, Arkansas, 72204

  • University of Arkanasas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • UCLA Medical Center

    Los Angeles, California, 90095

  • UW Health - West Clinic

    Madison, Wisconsin, 53792

  • Osler Medical Clinical Research

    Melbourne, Florida, 32901

  • Boise Kidney & Hypertension Institiute

    Meridian, Idaho, 83642

  • Egan Healthcare

    Metairie, Louisiana, 70002

  • Crescent City Clinical Research Center

    Metairie, Louisiana, 70006

  • University of South Alabama Medical Center

    Mobile, Alabama, 36617

  • Arthritis and Diabetes Clinic

    Monroe, Louisiana, 71203

  • UMDNJ-Robert Wood Johnson

    New Brunswick, New Jersey, 08903

  • Northern California Institute for Bone Health

    Oakland, California

  • Creighton Diabetes Center

    Omaha, Nebraska, 68131

  • Creighton Nephrology

    Omaha, Nebraska, 68131

  • SC Nephrology and Hyptertension Center, Inc.

    Orangeburg, South Carolina, 29115

  • HRRG

    Orchard Park, New York, 14127

  • Portland Hypertension and Nephrology

    Oregon City, Oregon, 97045

  • Dr. Wei Feng

    Pasadena, California, 91101

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Anasazi Internal Medicine

    Phoenix, Arizona, 85032

  • Mississippi Medical Research, LLC

    Picayune, Mississippi, 39466

  • Renal Endocrine Associates, P. C.

    Pittsburgh, Pennsylvania, 15224

  • Medical College of Virginia

    Richmond, Virginia, 23298-0111

  • Medical College of Virginia

    Richmond, Virginia, 23298

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Biolab Research, LLC

    Rockville, Maryland, 20852-1542

  • Sierra Clinical Research - Orangevale

    Roseville, California, 95661

  • Renal Associates, P.A.

    San Antonio, Texas, 78215

  • Allied Institute of Medicine

    San Antonio, Texas, 78222

  • California Institute of Renal Research

    San Diego, California, 92123

  • Sonoran Health Specialists

    Scottsdale, Arizona, 85260

  • Northwest Louisiana Nephrology Research

    Shreveport, Louisiana, 71101-4440

  • Washington State University at Spokane

    Spokane, Washington, 99202

  • Washington U School of Medicine

    St Louis, Missouri, 63110

  • Sumter Medical Specialists

    Sumter, South Carolina, 29150

  • SUNY - Upstate Medical University

    Syracuse, New York, 13210

  • Tampa Bay Nephrology Associates

    Tampa, Florida, 33603

  • Cotton-O'Neil Diabetes & Endocrinology Center

    Topeka, Kansas, 66606

  • Western Nephrology & Metabolic Bone Disease PC

    Westminster, Colorado, 80031

Other trials in United States

About this 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

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.

Being tested
vildagliptin, sitagliptin
Keywords
Type 2 diabetes, vildagliptin
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00770081
Study groupRoleWhat they receive
1Experimental50mg qd vildagliptin
Receives: Drug: vildagliptin
2Active comparatorsitagliptin (25mg qd)
Receives: Drug: sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 52 weeks

Secondary outcomes (1)

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

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00770081
Sponsor's protocol ID
CLAF237A23138E1
Status last verified
May 2012
First submitted
8 Oct 2008
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing vildagliptin and sitagliptin in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, run by Novartis at 87 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00770081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in