Diabetes Mellitus, Type 2Phase 3NCT00616811
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency
A Phase 3 study testing vildagliptin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Novartis at 79 sites in United States.
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 24… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- vildagliptin and Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 79 sitesUnited States
- Study dates
- Jan 2008to Oct 2010
- 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
- History T2 DM
- Severe Renal Impairment
Who cannot join
- Glucose ≥ 270 mg/dL (≥15 mmol/L)
- Patients undergoing any method of dialysis
- Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides
Trial locations and contacts
79 sites in 1 country.
79 sites in 1 country
United States79 sites
Aiken Center for Clinical Research
Aiken, South Carolina
University of New Mexico Health Science Center
Albuquerque, New Mexico
Lehigh Valley Hospital-Dept. of Medicine Research
Allentown, Pennsylvania
Central Utah Clinic
American Fork, Utah
Atlanta Diabetes Associates
Atlanta, Georgia
Emory Clinic
Atlanta, Georgia
Nephrology Associates of South Miami
Aventura, Florida
AM Diabetes and Endocrinology Center
Bartlett, Tennessee
Dolby Research, LLC
Baton Rouge, Louisiana
Metabolic Center of Louisiana
Baton Rouge, Louisiana
Downstate University of Brooklyn
Brooklyn, New York
Office of William Zigrang
Burlingame, California
Medical U of South Carolina
Charleston, South Carolina
Diabetes and Endocrinology Specialist, Inc
Chesterfield, Missouri
Hightop Medical Research Center
Cincinnati, Ohio
University of Cincinnati
Cincinnati, Ohio
The Ohio State University Medical Center
Columbus, Ohio
John Muir Clinical Research
Concord, California
Bruce Samuels LLC
Covington, Louisiana
Dallas Diabetes & Endocrine Center
Dallas, Texas
North Texas Endocrine Center
Dallas, Texas
Denver Nephrology PC
Denver, Colorado
Iowa Diabetes & Endocrinology Research Center PLC
Des Moines, Iowa
Medical Nephrology Associates
Dyersburg, Tennessee
Texas Tech University Health Sciences
El Paso, Texas
Willamette Valley Clinical Studies
Eugene, Oregon
Clinical Research and Consulting Center, LLC
Fairfax, Virginia
Meritcare Medical Group
Fargo, North Dakota
Genesys Integrated Group Practice, PC
Flint, Michigan
University of Florida Shands Hospital
Gainesville, Florida
Joslin Diabetes Center at North Arundel Hospital
Glen Burnie, Maryland
Hartford Hospital
Hartford, Connecticut
Center for Diabetes & Endocrine Care
Hollywood, Florida
University of Hawaii
Honolulu, Hawaii
Baylor Clinic (BCM 621)
Houston, Texas
Baylor College of Medicine
Houston, Texas
University of Iowa
Iowa City, Iowa
Phillips Medical Services, PLLC
Jackson, Mississippi
Jacksonville Center for Clinical Research
Jacksonville, Florida
Jefferson City Medical Group
Jefferson City, Missouri
Cray Diabetes Education Center
Kansas City, Kansas
Arms, Dodge, Robinson, Wilber & Crouch, Inc.
Kansas City, Missouri
Platte Valley Medical Group
Kearney, Nebraska
Western Nephrology & Metabolic Bone Disease PC
Lakewood, Colorado
University of Arkanasas for Medical Sciences
Little Rock, Arkansas
Academic Medical Research Institute
Los Angeles, California
UCLA Medical Center
Los Angeles, California
UW Health - West
Madison, Wisconsin
Osler Medical Clinical Research
Melbourne, Florida
Boise Kidney & Hypertension Institiute
Meridian, Idaho
Crescent City Clinical Research Center
Metairie, Louisiana
Egan Healthcare
Metairie, Louisiana
University of South Alabama Medical Center
Mobile, Alabama
Arthritis and Diabetes Clinic
Monroe, Louisiana
UMDNJ-Robert Wood Johnson
New Brunswick, New Jersey
Northern California Institute for Bone Health
Oakland, California
Creighton Diabetes Center
Omaha, Nebraska
Creighton Nephrology
Omaha, Nebraska
SC Nephrology and Hyptertension Center, Inc.
Orangeburg, South Carolina
HRRG
Orchard Park, New York
Dr. Wei Feng
Pasadena, California
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania
Anasazi Internal Medicine
Phoenix, Arizona
Mississippi Medical Research, LLC
Picayune, Mississippi
Renal Endocrine Associates, P. C.
Pittsburgh, Pennsylvania
Medical College of Virginia
Richmond, Virginia, 23298
Medical College of Virginia
Richmond, Virginia
Mayo Clinic Rochester
Rochester, New York
Biolab Research, LLC
Rockville, Maryland
Sierra Clinical Research - Orangevale
Roseville, California
Allied Institute of Medicine
San Antonio, Texas
Northwest Louisiana Nephrology Research
Shreveport, Louisiana
Washington State University at Spokane
Spokane, Washington
Washington U School of Medicine
St Louis, Missouri
Sumter Medical Specialists
Sumter, South Carolina
SUNY - Upstate Medical University
Syracuse, New York
Tampa Bay Nephrology Associates
Tampa, Florida
Cotton-O'Neil Diabetes & Endocrinology Center
Topeka, Kansas
Western Nephrology & Metabolic Bone Disease PC
Westminster, Colorado
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- vildagliptin, Sitagliptin
- Keywords
- Type 2 diabetes, vildagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vildagliptinDrug
SitagliptinDrug
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Not described Receives: Drug: vildagliptin |
| Sitagliptin | Active comparator | Not described Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment
Measured: 24 weeks
Secondary outcomes (2)
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.
Measured: 24 weekd
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals Corporation, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616811
- Sponsor's protocol ID
- CLAF237A23138
- Status last verified
- Jan 2013
- First submitted
- 4 Feb 2008
- Last updated
- 17 Dec 2020
- Results posted
- No
Publications
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.
PubMed 26067186
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00616811
- Acronym / sponsor ID
- CLAF237A23138
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, vildagliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: vildagliptin |
| Sitagliptin | Active comparator | Drug: Sitagliptin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History T2 DM
- Severe Renal Impairment
Key exclusion criteria (3 listed)
- Glucose ≥ 270 mg/dL (≥15 mmol/L)
- Patients undergoing any method of dialysis
- Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vildagliptin | Drug | Vildagliptin |
| Sitagliptin | Drug | Sitagliptin |
Primary outcome
Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment
Time frame: 24 weeks
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 26067186Kothny 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 for CLAF237A23138 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals Corporation study director
Novartis Pharmaceuticals
79 sites in 1 country: see every site and its status.
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, run by Novartis at 79 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 2 inclusion and 3 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 79 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?
Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment (time frame: 24 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 NCT00616811, which also lists 1 linked publication.
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.