Diabetes Mellitus, Type 2 Clinical Trial
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
| Verified date | January 2013 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 148 |
| Est. completion date | October 2010 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Aiken Center for Clinical Research | Aiken | South Carolina |
| United States | University of New Mexico Health Science Center | Albuquerque | New Mexico |
| United States | Lehigh Valley Hospital-Dept. of Medicine Research | Allentown | Pennsylvania |
| United States | Central Utah Clinic | American Fork | Utah |
| United States | Atlanta Diabetes Associates | Atlanta | Georgia |
| United States | Emory Clinic | Atlanta | Georgia |
| United States | Nephrology Associates of South Miami | Aventura | Florida |
| United States | AM Diabetes and Endocrinology Center | Bartlett | Tennessee |
| United States | Dolby Research, LLC | Baton Rouge | Louisiana |
| United States | Metabolic Center of Louisiana | Baton Rouge | Louisiana |
| United States | Downstate University of Brooklyn | Brooklyn | New York |
| United States | Office of William Zigrang | Burlingame | California |
| United States | Medical U of South Carolina | Charleston | South Carolina |
| United States | Diabetes and Endocrinology Specialist, Inc | Chesterfield | Missouri |
| United States | 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 | John Muir Clinical Research | Concord | California |
| United States | Bruce Samuels LLC | Covington | Louisiana |
| United States | Dallas Diabetes & Endocrine Center | Dallas | Texas |
| United States | North Texas Endocrine Center | Dallas | Texas |
| United States | Denver Nephrology PC | Denver | Colorado |
| United States | Iowa Diabetes & Endocrinology Research Center PLC | Des Moines | Iowa |
| United States | Medical Nephrology Associates | Dyersburg | Tennessee |
| United States | Texas Tech University Health Sciences | El Paso | Texas |
| United States | Willamette Valley Clinical Studies | Eugene | Oregon |
| United States | Clinical Research and Consulting Center, LLC | Fairfax | Virginia |
| United States | Meritcare Medical Group | Fargo | North Dakota |
| United States | Genesys Integrated Group Practice, PC | Flint | Michigan |
| United States | University of Florida Shands Hospital | Gainesville | Florida |
| United States | Joslin Diabetes Center at North Arundel Hospital | Glen Burnie | Maryland |
| United States | Hartford Hospital | Hartford | Connecticut |
| United States | Center for Diabetes & Endocrine Care | Hollywood | Florida |
| United States | University of Hawaii | Honolulu | Hawaii |
| United States | Baylor Clinic (BCM 621) | Houston | Texas |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | University of Iowa | Iowa City | Iowa |
| United States | Phillips Medical Services, PLLC | Jackson | Mississippi |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | Jefferson City Medical Group | Jefferson City | Missouri |
| United States | Arms, Dodge, Robinson, Wilber & Crouch, Inc. | Kansas City | Missouri |
| United States | Cray Diabetes Education Center | Kansas City | Kansas |
| United States | Platte Valley Medical Group | Kearney | Nebraska |
| United States | Western Nephrology & Metabolic Bone Disease PC | Lakewood | Colorado |
| United States | University of Arkanasas for Medical Sciences | Little Rock | Arkansas |
| United States | Academic Medical Research Institute | Los Angeles | California |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | UW Health - West | Madison | Wisconsin |
| United States | Osler Medical Clinical Research | Melbourne | Florida |
| United States | Boise Kidney & Hypertension Institiute | Meridian | Idaho |
| United States | Crescent City Clinical Research Center | Metairie | Louisiana |
| United States | Egan Healthcare | Metairie | Louisiana |
| United States | University of South Alabama Medical Center | Mobile | Alabama |
| United States | Arthritis and Diabetes Clinic | Monroe | Louisiana |
| United States | UMDNJ-Robert Wood Johnson | New Brunswick | New Jersey |
| United States | Northern California Institute for Bone Health | Oakland | California |
| United States | Creighton Diabetes Center | Omaha | Nebraska |
| United States | Creighton Nephrology | Omaha | Nebraska |
| United States | SC Nephrology and Hyptertension Center, Inc. | Orangeburg | South Carolina |
| United States | HRRG | Orchard Park | New York |
| United States | Dr. Wei Feng | Pasadena | California |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Anasazi Internal Medicine | Phoenix | Arizona |
| United States | Mississippi Medical Research, LLC | Picayune | Mississippi |
| United States | Renal Endocrine Associates, P. C. | Pittsburgh | Pennsylvania |
| United States | Medical College of Virginia | Richmond | Virginia |
| United States | Medical College of Virginia | Richmond | Virginia |
| United States | Mayo Clinic Rochester | Rochester | New York |
| United States | Biolab Research, LLC | Rockville | Maryland |
| United States | Sierra Clinical Research - Orangevale | Roseville | California |
| United States | Washington U School of Medicine | Saint Louis | Missouri |
| United States | Allied Institute of Medicine | San Antonio | Texas |
| United States | Northwest Louisiana Nephrology Research | Shreveport | Louisiana |
| United States | Washington State University at Spokane | Spokane | Washington |
| United States | Sumter Medical Specialists | Sumter | South Carolina |
| United States | SUNY - Upstate Medical University | Syracuse | New York |
| United States | Tampa Bay Nephrology Associates | Tampa | Florida |
| United States | Cotton-O'Neil Diabetes & Endocrinology Center | Topeka | Kansas |
| United States | Western Nephrology & Metabolic Bone Disease PC | Westminster | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment | 24 weeks | ||
| Secondary | 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. | 24 weekd | ||
| Secondary | 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 | 24 weeks |
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