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This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin Dose 1 | Experimental |
| |
| Vildagliptin Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug |
| ||
| Vildagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks | 24 weeks | |
| Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Research | Pell City | Alabama | 35128 | United States | ||
| Horizon Clinical Research Associates, PLLC |
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| Label | URL |
|---|---|
| Results for CLAF237B2201 from the Novartis Clinical Trials website | View source |
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|
| Placebo | Drug |
|
| 24 weeks |
| Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM | 76 weeks |
| Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM | 24 weeks |
| Gilbert |
| Arizona |
| 85206 |
| United States |
| Vista Medical Research, Inc | Mesa | Arizona | 85206 | United States |
| Clinical Research Advantage | Mesa | Arizona | 85213 | United States |
| Hope Clinical Research | Phoenix | Arizona | 85006 | United States |
| Anasazi Internal Medicine | Phoenix | Arizona | 85032 | United States |
| Tatum Ridge Internal Medicine | Phoenix | Arizona | 85032 | United States |
| Paradigm Clinical | Tucson | Arizona | 85705 | United States |
| Tucson Clinical Research | Tucson | Arizona | 85712 | United States |
| Medical Investigations, Inc. | Little Rock | Arkansas | 72205 | United States |
| Paul W. Davis, MD | Pine Bluff | Arkansas | 71603 | United States |
| Sall Research Medical Center | Artesia | California | 90704 | United States |
| Associated Pharmaceutical Research | Buena Park | California | 90620 | United States |
| Providence Research | Burbank | California | 91505 | United States |
| Burbank - Lovelace Scientific Resources, Inc. | Burbank | California | 91506 | United States |
| Lucita M. Cruz, M.D., Inc. | Norwalk | California | 90650 | United States |
| California Research Foundation | San Diego | California | 92103 | United States |
| Ritchken and First MDs | San Diego | California | 92117-4961 | United States |
| San Diego Sports Medicine Research and Family Care | San Diego | California | 92120 | United States |
| Crest Clinical Trials | Santa Ana | California | 92701 | United States |
| NuLife Clinical Research, Inc. | Santa Ana | California | 92805 | United States |
| Westside Arthritis and Metabolism Center | Santa Monica | California | 90404 | United States |
| Center for Clinical Trials of San Gabriel | West Covina | California | 91790 | United States |
| Colorado Springs Health Partners, Pc | Colorado Springs | Colorado | 80907 | United States |
| Express Care Clinical Research | Colorado Springs | Colorado | 80909 | United States |
| Cherry Creek Family Practice | Denver | Colorado | 80206 | United States |
| Metro Clinical Research | Littleton | Colorado | 80120 | United States |
| Complete Family Care | Northglenn | Colorado | 80234 | United States |
| Clinical Therapeutics Corp | Coral Gables | Florida | 33134 | United States |
| Fort Lauderdale | Florida | 33308 | United States |
| South Florida Clinical Research Center | Miramar | Florida | 33023 | United States |
| Pines Research, LLC | Pembroke Pines | Florida | 33028 | United States |
| Well Pharma Medical Research | South Miami | Florida | 33143 | United States |
| Southern Clinical Research | Augusta | Georgia | 30904 | United States |
| Rockdale Medical Research | Conyers | Georgia | 30094 | United States |
| North Georgia Medical Research Institute | Ellijay | Georgia | 30540 | United States |
| Perimeter North Medical Research | Roswell | Georgia | 30076 | United States |
| JMG CIinical Research | Alton | Illinois | 62002 | United States |
| Fox Valley Clinical Research | Aurora | Illinois | 60504 | United States |
| American Health Network | Indianapolis | Indiana | 46254 | United States |
| Mercy Family Medicine | Mason City | Iowa | 50401 | United States |
| Associates Research, Inc | Lansing | Kansas | 66043 | United States |
| Health Science Research Center | Pratt | Kansas | 67124 | United States |
| Cotton O'neil Clinic | Topeka | Kansas | 66606 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67205 | United States |
| Dolby Research, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Bruce Samuels LLC | Covington | Louisiana | 70433 | United States |
| Gulf Coast Research, LLC | Lafayette | Louisiana | 70508 | United States |
| Crescent City Clinical Research Center | Metairie | Louisiana | 70006 | United States |
| The Family Doctors | Shreveport | Louisiana | 71115 | United States |
| Maine Centers for Endocrinology & Diabetes | Scarborough | Maine | 04074 | United States |
| Michigan Hypertension Center | Chelsea | Michigan | 48118 | United States |
| Genesys Integrated Group Practice, PC | Flint | Michigan | 48532 | United States |
| Borgess Heart Institute-Borgess Research Institute | Kalamazoo | Michigan | 49048 | United States |
| NISUS Research Northern MI Hospital | Petoskey | Michigan | 49770-2212 | United States |
| Spence Medical Research Center, LLC | Pinckney | Michigan | 39466 | United States |
| Southwestern Medical Clinic, PC | Stevensville | Michigan | 49127 | United States |
| Belzoni Clinical Research | Belzoni | Mississippi | 39038 | United States |
| Gulfside Clinical Research | Gulfport | Mississippi | 39501 | United States |
| Mississippi Medical Research, LLC | Picayune | Mississippi | 39466 | United States |
| Woodlake Research | Chesterfield | Missouri | 63017 | United States |
| Midwest Pharmaceutical Research Inc. | City of Saint Peters | Missouri | 63376 | United States |
| Midwest Pharmaceutical Research, Inc. | City of Saint Peters | Missouri | 63376 | United States |
| Truman Medical Center & Univ Physician Associates | Kansas City | Missouri | 64108 | United States |
| Ozark Mountains Medical Research | Ozark | Missouri | 65721 | United States |
| Ozark Medical-Surgical Associates, Ltd. | Springfield | Missouri | 65804 | United States |
| ClinVest Research | Springfield | Missouri | 65807 | United States |
| Patient's First Health Care | Washington | Missouri | 63090 | United States |
| Physician Research Collaboration | Lincoln | Nebraska | 68516 | United States |
| Fallbrook Family Health Center | Lincoln | Nebraska | 68521 | United States |
| Quality Clinical Research | Omaha | Nebraska | 68114 | United States |
| Heartland Clinical Research, Inc. | Omaha | Nebraska | 68134 | United States |
| Desert Endocrinology Clinical Research Center | Henderson | Nevada | 89052 | United States |
| Clinical Research Center of NV | Las Vegas | Nevada | 89104 | United States |
| Palm Medical Research Center | Las Vegas | Nevada | 89148 | United States |
| Joslin Diabetes Center | Nashua | New Hampshire | 03063 | United States |
| Shore Health Group | Toms River | New Jersey | 08753 | United States |
| Physicians Research Center | Toms River | New Jersey | 08755 | United States |
| The Endocrine Group, LLP | Albany | New York | 12206 | United States |
| Endwell Family Physician | Endwell | New York | 13760 | United States |
| North Shore Diabetes and Endocrine Associates | New Hyde Park | New York | 11042 | United States |
| Mezitis Education & Research Institute | New York | New York | 10024 | United States |
| Cornerstone Medical Center | Burlington | North Carolina | 27215 | United States |
| Kernodle Clinic, Inc. | Burlington | North Carolina | 27215 | United States |
| Neem Research Group of Charlotte | Charlotte | North Carolina | 28262 | United States |
| Bland Clinic, PA | Greensboro | North Carolina | 27401 | United States |
| Triad Clinical Trials, LLC | Greensboro | North Carolina | 27408 | United States |
| Private Practice | Raleigh | North Carolina | 27610 | United States |
| Crescent Medical Research | Salisbury | North Carolina | 28144 | United States |
| Jones Family Practice, PA | Shelby | North Carolina | 28150 | United States |
| The Lipid Center | Statesville | North Carolina | 28677 | United States |
| Lillestol Research, LLC | Fargo | North Dakota | 58103 | United States |
| Frederick C. Smith Clinic R & R Research | Marion | Ohio | 43302 | United States |
| Pharmacotherapy Research Associates, INC | Zanesville | Ohio | 43071 | United States |
| Central Sooner Research | Norman | Oklahoma | 73069 | United States |
| Lion Research | Norman | Oklahoma | 73069 | United States |
| Integris Physicians Services Clinical Research | Oklahoma City | Oklahoma | 73112 | United States |
| Memorial Clinical Research | Oklahoma City | Oklahoma | 73134 | United States |
| Blair Medical Associates Inc | Altoona | Pennsylvania | 16602 | United States |
| Tri-State Medical Group | Beaver | Pennsylvania | 15009 | United States |
| Fleetwood Medical Associates | Fleetwood | Pennsylvania | 19522 | United States |
| Family Medical Associates | Levittown | Pennsylvania | 19056 | United States |
| New England Center for Clinical Research | Cranston | Rhode Island | 02920 | United States |
| Hartwell Research Group, LLC | Anderson | South Carolina | 29621 | United States |
| Low Country Internal Medicine | Charleston | South Carolina | 29406 | United States |
| Pharmacorp Clinical Trials, INC | Charleston | South Carolina | 29412 | United States |
| The Family Healthcare Center | Clinton | South Carolina | 29325 | United States |
| Columbia Clinical Research | Columbia | South Carolina | 29201 | United States |
| Med Plus South - Strand Family Practice | Garden City | South Carolina | 29576 | United States |
| DeGarmo Institute of Medical Research | Greer | South Carolina | 29651 | United States |
| Dorchester Medical Associates | Summerville | South Carolina | 29485 | United States |
| Southeastern Research Associates, Inc. | Taylors | South Carolina | 28687 | United States |
| Community Research Partners, Inc. | Varnville | South Carolina | 29944 | United States |
| AM Diabetes and Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| Tri-Cities Medical Research | Bristol | Tennessee | 37620 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| ACRC Trials | Addison | Texas | 75093 | United States |
| Discover Research Inc. | Beaumont | Texas | 77701 | United States |
| MW Clinical Research | Beaumont | Texas | 77701 | United States |
| Discover Research | Bryan | Texas | 77802 | United States |
| Z&Z Medical Associates/Internal Medicine Clinical Research | Dallas | Texas | 75235 | United States |
| Western Sky Medical Research | El Paso | Texas | 79902 | United States |
| HCA Research | Houston | Texas | 77025 | United States |
| Texas Center for Drug Development, P.A. | Houston | Texas | 77081 | United States |
| Leading Edge Research, PA | Irving | Texas | 75039 | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | United States |
| South Texas Institutes of Health | McAllen | Texas | 78501 | United States |
| Hill Country Medical Associates | New Braunfels | Texas | 78130 | United States |
| North Hills Family Practice | North Richland Hills | Texas | 76180 | United States |
| Naidu Clinic | Odessa | Texas | 79761 | United States |
| Med-Olam Clinical Research | Pasadena | Texas | 77504 | United States |
| Southwest Clinical Research Centers, LLC | Pearland | Texas | 77584 | United States |
| Diabetes & Glandular Disease Clinic , PA | San Antonio | Texas | 78237 | United States |
| Progressive Clinical Research | Bountiful | Utah | 84010 | United States |
| Utah Clinical Trials | Salt Lake City | Utah | 84107 | United States |
| Diabetes Research Center | South Burlington | Vermont | 05403 | United States |
| Northport VA Medical Center | Northport | Virginia | 11768 | United States |
| Holston Medical Group | Weber City | Virginia | 24920 | United States |
| Madrona Medical Group - Clinical Research Dept. | Bellingham | Washington | 98226 | United States |
| Summit Reserach Network, LLC | Seattle | Washington | 98104 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| G.A. Research Associates Moncton, New Brunswick E1G 1 A7 | Moncton | New Brunswick | E1G 1 A7 | Canada |
| T.C. Health Center | Carbonear | Newfoundland and Labrador | A1Y 1C4 | Canada |
| LMC Endocrinology Centres (Barrie) Ltd. | Barrie | Ontario | L4M 7G1 | Canada |
| LMC Endocrinology Centres -(Etobicoke) Ltd. , | Etobicoke | Ontario | M9R 4E1 | Canada |
| LMC Endocrinology Centres -(Thornhill) | Thornhill | Ontario | L4J 8L7 | Canada |
| LMC Endocrinology Centres (Toronto) Ltd. | Toronto | Ontario | M4R 2G4 | Canada |
| Madras Diabetes Research Foundation | Gopālapuram | Chennai | 600 086 | India |
| Medicity Hospital | Hyderabaad | Hyderabad | 500 036 | India |
| Manipal Hospital | Bangalore | 560 017 | India |
| MV Hospital for Diabetes and Diabetes Research Centre | Chennai | 600 013 | India |
| Diabetes Thyroid Hormone Research Institute Pvt Ltd. | Indore | 452 001 | India |
| Christian Medical College | Vellore | 632 004 | India |
| University Malaya Medical Centre | Selangor Darul Ehsan | Ehsan | Malaysia |
| Hospital University Kebangsaan Malaysia | Kuala Lumpur | Selangor | Malaysia |
| Hospital Putrajaya | Selangor Darul Ehsan | Selangor | Malaysia |
| Jose R. Reyes Memorial Medical Center | Sta Cruz | Manila | Philippines |
| Metropolitan Medical Center | Manila | Philippines |
| Institute for Studies on Diabetes Foundation | Marikina City | Philippines |
| Policlinica Dr. Luis Rodriguez Carrasquillo | Carolina | 00983 | Puerto Rico |
| Yolanda Sierra Medical Office | Levittown | 00949 | Puerto Rico |
| Endocrine Lipid Diabetes Research Institute | Ponce | 00717-1471 | Puerto Rico |
| Centro Clinico San Patricio | San Juan | 00921 | Puerto Rico |
| Miguel Sosa-Padilla, M.D. | San Juan | 00926 | Puerto Rico |
| CMI Cardiologie | Baia Mare | Romania |
| Paulescu Institute | Bucharest | Romania |
| Anamed SRL | Oradea | Romania |
| Emergency County Hospital Ploiesti | Ploieşti | Romania |
| Policlinica | Timișoara | Romania |
| Diabetologicka ambulancia | Komarnanska | Velky Meder | 932 01 | Slovakia |
| Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia | Košice | 040 01 | Slovakia |
| Diabetologicka ambulancia | Nové Mesto nad Váhom | 915 01 | Slovakia |
| Diabetologicka ambulancia | Prešov | Slovakia |
| Mestska poliklinika Sered, Diabetologicka ambulancia | Sereď | 926 01 | Slovakia |
| Diabetologicka ambulancia | Šahy | 936 01 | Slovakia |
| Diabetologicka ambulancia | Trebišov | 075 01 | Slovakia |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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