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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)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 50mg qd vildagliptin |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug | 50mg qd |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica de Fracturas y Ortopedia | Buenos Aires | Argentina | ||||
| Hospital Teodoro Alvarez |
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| Label | URL |
|---|---|
| Results for CLAF237A23137E1 from the Novartis Clinical Trials website | View source |
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| Drug |
qd |
|
| Buenos Aires |
| Argentina |
| Instituto de Investigaciones Clinicas de Mar del Plata | Buenos Aires | Argentina |
| Instituto Medico Especializado IME | Buenos Aires | Argentina |
| Hospital Juan Ramon Vidal | Corrientes | Argentina |
| Clinica Reina Fabiola | Córdoba | Argentina |
| Hospital Zenon J. Santillan | San Miguel de Tucumán | Argentina |
| The Queen Elizabeth Hospital | Woodville | South Australia | Australia |
| Heidelberg Repatriation Hospital | Heidelberg Heights | Australia |
| SA Endocrine Clinical Research | Keswick | Australia |
| Keogh Medical Research Institute | Nedlands Perth | Australia |
| St Vincent's Hospital (Melb) | Victoria | Australia |
| ERS Endocrine Research Society | Vancouver | British Columbia | Canada |
| Health Sciences Centre - Diabetes Research Group | Winnipeg | Manitoba | Canada |
| Co Medica Research Network Inc. | Courtice | Ontario | Canada |
| Ultra Med Inc. | Pointe-Claire | Quebec | Canada |
| Centre de Recherche de Laval | Laval | Canada |
| Private Office (Gottesman) | Ontario | Canada |
| Hopital Maisonneuve-Rosemont | Québec | Canada |
| Health Sciences Centre - Diabetes Research Group | Winnipeg | Canada |
| Clínica Vía San Juan | Cartago | Costa Rica |
| Clínica de Endocrinología y Diabetes | San José | Costa Rica |
| Clínica San Agustín | San José | Costa Rica |
| Hospital Clínica Bíblica | San José | Costa Rica |
| Satakunnan Keskussairaala | Pori | Finland |
| Mediwest Research Center | Seinäjoki | Finland |
| Tampereen lääkärikeskus Oy, Koskiklinikka | Tampere | Finland |
| Cabinet du Dr Arnou | Angers | France |
| Cabinet du Dr Giraud Philippe | Angers | France |
| Hôpital Docteur Duchenne | Boulogne-sur-Mer | France |
| Hopital Albert Michallon | Grenoble | France |
| Cabinet médical | Laval | France |
| Hopital Dupuytren | Limoges | France |
| Hopital Edouard Herriot | Lyon | France |
| Zentralklinikum Augsburg | Augsburg | Germany |
| Praxis Dr. Maxeiner | Bad Kreuznach | Germany |
| Universitaetsklinik Charitè | Berlin | Germany |
| Praxis Dr. Fischer | Darmstadt | Germany |
| Praxis Dr. Merker | Dormagen | Germany |
| Univ.-Klinikum Erlangen | Erlangen | Germany |
| Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann | Frankfurt | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Friedrich Schiller Universitaet Jena | Jena | Germany |
| CRS Clinical Research Services Gmbh | Kiel | Germany |
| I. Medizinische Univ.-Klinik | Kiel | Germany |
| Praxis Dr. Hennig | Meissen | Germany |
| Praxis Dr. Grimm | München | Germany |
| Univ.-Klinikum München, Campus Innenstadt | München | Germany |
| Praxis Dr. Schoell | Nuremberg | Germany |
| Forschungszentrum Ruhr, KliFoCenter GmbH | Witten | Germany |
| Universitaetsklinik im Luitpold-Krankenhaus | Würzburg | Germany |
| Gujarat Endocrine Centre | Ahmedabad | India |
| M V Hospital for Diabetes and Diabetic Research Center | Chennai | India |
| Coimbatore Diabetes Foundation | Coimbatore | India |
| S.R. Kalla Memorial Gastro & General Hospital | Jaipur | India |
| Meenakshi Mission Hospital & Research Centre | Madurai | India |
| Diabetes Clinic & Research Centre | Nagpur | India |
| Storoklinikken | Oslo | Norway |
| St. Olavs Hospital, Endokrinologisk seksjon | Trondheim | Norway |
| City Clinical Hospital #6 | Chelyabinsk | Russia |
| City Clinical Hospital #1 | Moscow | Russia |
| City Clinical Hospital No.11 | Moscow | Russia |
| MSU of Medicine and Dentistry on the base of CityHospital 23 | Moscow | Russia |
| MSUMD on the base of City Clinical Hospital #67 | Moscow | Russia |
| City polyclinic # 17, City Diabetic Centre #3 | Saint Petersburg | Russia |
| Krestovsky Island Medical Institute | Saint Petersburg | Russia |
| Saint- Petersburg State Mtchnikov's Medical Academy | Saint Petersburg | Russia |
| Saint-Petersburg State Pavlov's Medical University | Saint Petersburg | Russia |
| Site Management Organisation of Clinical Trials Centers | Smolensk | Russia |
| Tyumen State Medicine Academy | Tyumen | Russia |
| Clinica Mediterranea de Neurociencias | Alicante | Spain |
| Hospital de la Ribera | Alzira | Spain |
| Hospital Clinic I Provincial de Barcelona | Barcelona | Spain |
| Centro de Salud Begonte | Begonte | Spain |
| Hospital San Pedro de Alcantara | Cáceres | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Spain |
| Hospital General de Jerez de La Frontera | Jerez de la Frontera | Spain |
| Ciutat Sanitaria I Universitaria de Bellvitge | L'Hospitalet de Llobregat | Spain |
| Complejo Universitario de San Carlos | Madrid | Spain |
| Hospital de Merida | Mérida | Spain |
| Hospital Son Dureta | Palma de Mallorca | Spain |
| Consorci Hospitalari Parc Tauli | Sabadell | Spain |
| Hospital Clinico Universitario Santiago de Compostela | Santiago de Compostela | Spain |
| Eap El Remei - Vic | Vic | Spain |
| ME3PLUS Clinical Trials | Gothenburg | Sweden |
| Njurmedicin, Sahlgrenska Univ.sjukhuset | Gothenburg | Sweden |
| Metabolmottagningen, Lasarettet, Kristianstad | Kristianstad | Sweden |
| VO Endokrinologi/Diabetologi Universitetssjukhuset | Lund | Sweden |
| Ladulaas Kliniska Studier | Skene | Sweden |
| 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 |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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