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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 50mg qd vildagliptin |
|
| 2 | Active Comparator | sitagliptin (25mg qd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug | 50mg qd |
| |
| sitagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | United States | ||
| Anasazi Internal Medicine |
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| Label | URL |
|---|---|
| Results for CLAF237A23138E1 from the Novartis Clinical Trials website | View source |
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| Drug |
25mg qd |
|
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Sonoran Health Specialists | Scottsdale | Arizona | 85260 | United States |
| Mary K. Richards, MD. PA | Little Rock | Arkansas | 72204 | United States |
| University of Arkanasas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Burlingame | California | 94010 | United States |
| John Muir Clinical Research | Concord | California | 94520 | United States |
| Academic Medical Research Institute | Los Angeles | California | 90022 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Northern California Institute for Bone Health | Oakland | California | United States |
| Dr. Wei Feng | Pasadena | California | 91101 | United States |
| Sierra Clinical Research - Orangevale | Roseville | California | 95661 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| Denver Nephrology PC | Denver | Colorado | 80230 | United States |
| Western Nephrology & Metabolic Bone Disease PC | Lakewood | Colorado | 80214 | United States |
| Western Nephrology & Metabolic Bone Disease PC | Westminster | Colorado | 80031 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Nephrology Associates of South Miami | Aventura | Florida | 33180 | United States |
| University of Florida Shands Hospital | Gainesville | Florida | 32610 | United States |
| Center for Diabetes & Endocrine Care | Hollywood | Florida | 33021 | United States |
| Larry Levinson, D.O., PA | Hollywood | Florida | 33021 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Osler Medical Clinical Research | Melbourne | Florida | 32901 | United States |
| Tampa Bay Nephrology Associates | Tampa | Florida | 33603 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | United States |
| Emory Clinic | Atlanta | Georgia | 30322 | United States |
| University of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Boise Kidney & Hypertension Institiute | Meridian | Idaho | 83642 | United States |
| Iowa Diabetes & Endocrinology Research Center PLC | Des Moines | Iowa | 50314 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Cray Diabetes Education Center | Kansas City | Kansas | 66160 | United States |
| Cotton-O'Neil Diabetes & Endocrinology Center | Topeka | Kansas | 66606 | United States |
| Metabolic Center of Louisiana | Baton Rouge | Louisiana | 70808 | United States |
| Dolby Research, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Bruce Samuels LLC | Covington | Louisiana | 70433 | United States |
| Egan Healthcare | Metairie | Louisiana | 70002 | United States |
| Crescent City Clinical Research Center | Metairie | Louisiana | 70006 | United States |
| Arthritis and Diabetes Clinic | Monroe | Louisiana | 71203 | United States |
| Northwest Louisiana Nephrology Research | Shreveport | Louisiana | 71101-4440 | United States |
| Joslin Diabetes Center at North Arundel Hospital | Glen Burnie | Maryland | 21061 | United States |
| Biolab Research, LLC | Rockville | Maryland | 20852-1542 | United States |
| Harvard University (Joslin Diabetes Center) | Boston | Massachusetts | 02215 | United States |
| Genesys Integrated Group Practice, PC | Flint | Michigan | 49532 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Phillips Medical Services, PLLC | Jackson | Mississippi | 39209 | United States |
| Mississippi Medical Research, LLC | Picayune | Mississippi | 39466 | United States |
| Diabetes and Endocrinology Specialist, Inc | Chesterfield | Missouri | 63017 | United States |
| Jefferson City Medical Group | Jefferson City | Missouri | 65109 | United States |
| Arms, Dodge, Robinson, Wilber & Crouch, Inc. | Kansas City | Missouri | 64111 | United States |
| Washington U School of Medicine | St Louis | Missouri | 63110 | United States |
| Platte Valley Medical Group | Kearney | Nebraska | 68848 | United States |
| Creighton Diabetes Center | Omaha | Nebraska | 68131 | United States |
| Creighton Nephrology | Omaha | Nebraska | 68131 | United States |
| UMDNJ-Robert Wood Johnson | New Brunswick | New Jersey | 08903 | United States |
| University of New Mexico Health Science Center | Albuquerque | New Mexico | 87131 | United States |
| Downstate University of Brooklyn | Brooklyn | New York | 11203-2056 | United States |
| HRRG | Orchard Park | New York | 14127 | United States |
| SUNY - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Meritcare Medical Group | Fargo | North Dakota | 58122 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45206 | United States |
| Hightop Medical Research Center | Cincinnati | Ohio | 45224 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Willamette Valley Clinical Studies | Eugene | Oregon | 97404 | United States |
| Portland Hypertension and Nephrology | Oregon City | Oregon | 97045 | United States |
| Lehigh Valley Hospital-Dept. of Medicine Research | Allentown | Pennsylvania | 18105 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Renal Endocrine Associates, P. C. | Pittsburgh | Pennsylvania | 15224 | United States |
| Aiken Center for Clinical Research | Aiken | South Carolina | 29801 | United States |
| Medical U of South Carolina | Charleston | South Carolina | 29425 | United States |
| SC Nephrology and Hyptertension Center, Inc. | Orangeburg | South Carolina | 29115 | United States |
| Sumter Medical Specialists | Sumter | South Carolina | 29150 | United States |
| AM Diabetes and Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| Medical Nephrology Associates | Dyersburg | Tennessee | 38024 | United States |
| Dallas Diabetes & Endocrine Center | Dallas | Texas | 75230 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Baylor Clinic (BCM 621) | Houston | Texas | 770303411 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Renal Associates, P.A. | San Antonio | Texas | 78215 | United States |
| Allied Institute of Medicine | San Antonio | Texas | 78222 | United States |
| Central Utah Clinic | American Fork | Utah | 84003 | United States |
| Clinical Research and Consulting Center, LLC | Fairfax | Virginia | 22030 | United States |
| Nephrology Associates of Northern Virginia | Fairfax | Virginia | 22033 | United States |
| Medical College of Virginia | Richmond | Virginia | 23298-0111 | United States |
| Medical College of Virginia | Richmond | Virginia | 23298 | United States |
| Washington State University at Spokane | Spokane | Washington | 99202 | United States |
| UW Health - West Clinic | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D011719 | Pyrazines |
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