Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00616811
First received: February 4, 2008
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: vildagliptin Drug: Sitagliptin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 24 weekd ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 148 |
| Study Start Date: | January 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vildagliptin | Drug: vildagliptin |
| Active Comparator: Sitagliptin | Drug: Sitagliptin |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616811
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Hide Study LocationsLocations
| United States, Alabama | |
| University of South Alabama Medical Center | |
| Mobile, Alabama, United States | |
| United States, Arizona | |
| Anasazi Internal Medicine | |
| Phoenix, Arizona, United States | |
| United States, Arkansas | |
| University of Arkanasas for Medical Sciences | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Office of William Zigrang | |
| Burlingame, California, United States | |
| John Muir Clinical Research | |
| Concord, California, United States | |
| Academic Medical Research Institute | |
| Los Angeles, California, United States | |
| UCLA Medical Center | |
| Los Angeles, California, United States | |
| Northern California Institute for Bone Health | |
| Oakland, California, United States | |
| Dr. Wei Feng | |
| Pasadena, California, United States | |
| Sierra Clinical Research - Orangevale | |
| Roseville, California, United States | |
| United States, Colorado | |
| Denver Nephrology PC | |
| Denver, Colorado, United States | |
| Western Nephrology & Metabolic Bone Disease PC | |
| Lakewood, Colorado, United States | |
| Western Nephrology & Metabolic Bone Disease PC | |
| Westminster, Colorado, United States | |
| United States, Connecticut | |
| Hartford Hospital | |
| Hartford, Connecticut, United States | |
| United States, Florida | |
| Nephrology Associates of South Miami | |
| Aventura, Florida, United States | |
| University of Florida Shands Hospital | |
| Gainesville, Florida, United States | |
| Center for Diabetes & Endocrine Care | |
| Hollywood, Florida, United States | |
| Jacksonville Center for Clinical Research | |
| Jacksonville, Florida, United States | |
| Osler Medical Clinical Research | |
| Melbourne, Florida, United States | |
| Tampa Bay Nephrology Associates | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Atlanta Diabetes Associates | |
| Atlanta, Georgia, United States | |
| Emory Clinic | |
| Atlanta, Georgia, United States | |
| United States, Hawaii | |
| University of Hawaii | |
| Honolulu, Hawaii, United States | |
| United States, Idaho | |
| Boise Kidney & Hypertension Institiute | |
| Meridian, Idaho, United States | |
| United States, Iowa | |
| Iowa Diabetes & Endocrinology Research Center PLC | |
| Des Moines, Iowa, United States | |
| University of Iowa | |
| Iowa City, Iowa, United States | |
| United States, Kansas | |
| Cray Diabetes Education Center | |
| Kansas City, Kansas, United States | |
| Cotton-O'Neil Diabetes & Endocrinology Center | |
| Topeka, Kansas, United States | |
| United States, Louisiana | |
| Dolby Research, LLC | |
| Baton Rouge, Louisiana, United States | |
| Metabolic Center of Louisiana | |
| Baton Rouge, Louisiana, United States | |
| Bruce Samuels LLC | |
| Covington, Louisiana, United States | |
| Egan Healthcare | |
| Metairie, Louisiana, United States | |
| Crescent City Clinical Research Center | |
| Metairie, Louisiana, United States | |
| Arthritis and Diabetes Clinic | |
| Monroe, Louisiana, United States | |
| Northwest Louisiana Nephrology Research | |
| Shreveport, Louisiana, United States | |
| United States, Maryland | |
| Joslin Diabetes Center at North Arundel Hospital | |
| Glen Burnie, Maryland, United States | |
| Biolab Research, LLC | |
| Rockville, Maryland, United States | |
| United States, Michigan | |
| Genesys Integrated Group Practice, PC | |
| Flint, Michigan, United States | |
| United States, Mississippi | |
| Phillips Medical Services, PLLC | |
| Jackson, Mississippi, United States | |
| Mississippi Medical Research, LLC | |
| Picayune, Mississippi, United States | |
| United States, Missouri | |
| Diabetes and Endocrinology Specialist, Inc | |
| Chesterfield, Missouri, United States | |
| Jefferson City Medical Group | |
| Jefferson City, Missouri, United States | |
| Arms, Dodge, Robinson, Wilber & Crouch, Inc. | |
| Kansas City, Missouri, United States | |
| Washington U School of Medicine | |
| St. Louis, Missouri, United States | |
| United States, Nebraska | |
| Platte Valley Medical Group | |
| Kearney, Nebraska, United States | |
| Creighton Nephrology | |
| Omaha, Nebraska, United States | |
| Creighton Diabetes Center | |
| Omaha, Nebraska, United States | |
| United States, New Jersey | |
| UMDNJ-Robert Wood Johnson | |
| New Brunswick, New Jersey, United States | |
| United States, New Mexico | |
| University of New Mexico Health Science Center | |
| Albuquerque, New Mexico, United States | |
| United States, New York | |
| Downstate University of Brooklyn | |
| Brooklyn, New York, United States | |
| HRRG | |
| Orchard Park, New York, United States | |
| Mayo Clinic Rochester | |
| Rochester, New York, United States | |
| SUNY - Upstate Medical University | |
| Syracuse, New York, United States | |
| United States, North Dakota | |
| Meritcare Medical Group | |
| Fargo, North Dakota, United States | |
| United States, Ohio | |
| Hightop Medical Research Center | |
| Cincinnati, Ohio, United States | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States | |
| The Ohio State University Medical Center | |
| Columbus, Ohio, United States | |
| United States, Oregon | |
| Willamette Valley Clinical Studies | |
| Eugene, Oregon, United States | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital-Dept. of Medicine Research | |
| Allentown, Pennsylvania, United States | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States | |
| Renal Endocrine Associates, P. C. | |
| Pittsburgh, Pennsylvania, United States | |
| United States, South Carolina | |
| Aiken Center for Clinical Research | |
| Aiken Center, South Carolina, United States | |
| Medical U of South Carolina | |
| Charleston, South Carolina, United States | |
| SC Nephrology and Hyptertension Center, Inc. | |
| Orangeburg, South Carolina, United States | |
| Sumter Medical Specialists | |
| Sumter, South Carolina, United States | |
| United States, Tennessee | |
| AM Diabetes and Endocrinology Center | |
| Bartlett, Tennessee, United States | |
| Medical Nephrology Associates | |
| Dyersburg, Tennessee, United States | |
| United States, Texas | |
| Dallas Diabetes & Endocrine Center | |
| Dallas, Texas, United States | |
| North Texas Endocrine Center | |
| Dallas, Texas, United States | |
| Texas Tech University Health Sciences | |
| El Paso, Texas, United States | |
| Baylor Clinic (BCM 621) | |
| Houston, Texas, United States | |
| Baylor College of Medicine | |
| Houston, Texas, United States | |
| Allied Institute of Medicine | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Central Utah Clinic | |
| American Fork, Utah, United States | |
| United States, Virginia | |
| Clinical Research and Consulting Center, LLC | |
| Fairfax, Virginia, United States | |
| Medical College of Virginia | |
| Richmond, Virginia, United States | |
| Medical College of Virginia | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Washington State University at Spokane | |
| Spokane, Washington, United States | |
| United States, Wisconsin | |
| UW Health - West | |
| Madison, Wisconsin, United States | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals Corporation | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00616811 History of Changes |
| Other Study ID Numbers: | CLAF237A23138 |
| Study First Received: | February 4, 2008 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Type 2 diabetes, vildagliptin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Renal Insufficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Kidney Diseases Urologic Diseases Vildagliptin |
Sitagliptin Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013