Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or 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)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency
| Status | Completed |
| Enrollment | 349 |
| Est. completion date | April 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: - Complete the core study Exclusion Criteria: - Did not comply with core study requirements |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Clinica de Fracturas y Ortopedia | Buenos Aires | |
| Argentina | Hospital Teodoro Alvarez | Buenos Aires | |
| Argentina | Instituto de Investigaciones Clinicas de Mar del Plata | Buenos Aires | |
| Argentina | Instituto Medico Especializado IME | Buenos Aires | |
| Argentina | Clinica Reina Fabiola | Cordoba | |
| Argentina | Hospital Juan Ramon Vidal | Corrientes | |
| Argentina | Hospital Zenon J. Santillan | San Miguel de Tucuman | |
| 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 | The Queen Elizabeth Hospital | Woodville | South Australia |
| Canada | Co Medica Research Network Inc. | Courtice | Ontario |
| Canada | Centre de Recherche de Laval | Laval | |
| Canada | Private Office (Gottesman) | Ontario | |
| Canada | Ultra Med Inc. | Pointe-Claire | Quebec |
| Canada | Hopital Maisonneuve-Rosemont | Quebec | |
| Canada | ERS Endocrine Research Society | Vancouver | British Columbia |
| Canada | Health Sciences Centre - Diabetes Research Group | Winnipeg | Manitoba |
| Canada | Health Sciences Centre - Diabetes Research Group | Winnipeg | |
| Costa Rica | Clínica Vía San Juan | Cartago | |
| Costa Rica | Clínica de Endocrinología y Diabetes | San Jose | |
| Costa Rica | Clínica San Agustín | San Jose | |
| Costa Rica | Hospital Clínica Bíblica | San Jose | |
| Finland | Satakunnan Keskussairaala | Pori | |
| Finland | Mediwest Research Center | Seinajoki | |
| Finland | Tampereen lääkärikeskus Oy, Koskiklinikka | Tampere | |
| France | Cabinet du Dr Arnou | Angers | |
| France | Cabinet du Dr Giraud Philippe | Angers | |
| France | Hôpital Docteur Duchenne | Boulogne-sur-Mer | |
| France | Hopital Albert Michallon | Grenoble cedex 9 | |
| France | Cabinet médical | Laval | |
| France | Hopital Dupuytren | Limoges Cedex | |
| France | Hopital Edouard Herriot | Lyon | |
| Germany | 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 | Hannover | |
| 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 | Muenchen | |
| Germany | Univ.-Klinikum München, Campus Innenstadt | München | |
| Germany | Praxis Dr. Schoell | Nuernberg | |
| Germany | Forschungszentrum Ruhr, KliFoCenter GmbH | Witten | |
| Germany | Universitaetsklinik im Luitpold-Krankenhaus | Wuerzburg | |
| India | 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 | |
| Norway | Storoklinikken | Oslo | |
| Norway | St. Olavs Hospital, Endokrinologisk seksjon | Trondheim | |
| Russian Federation | City Clinical Hospital #6 | Chelyabinsk | |
| Russian Federation | City Clinical Hospital #1 | Moscow | |
| Russian Federation | City Clinical Hospital No.11 | Moscow | |
| Russian Federation | MSU of Medicine and Dentistry on the base of CityHospital 23 | Moscow | |
| Russian Federation | MSUMD on the base of City Clinical Hospital #67 | Moscow | |
| Russian Federation | City polyclinic # 17, City Diabetic Centre #3 | Saint Petersburg | |
| Russian Federation | Krestovsky Island Medical Institute | Saint Petersburg | |
| Russian Federation | Saint- Petersburg State Mtchnikov's Medical Academy | Saint-Petersburg | |
| Russian Federation | Saint-Petersburg State Pavlov's Medical University | Saint-Petersburg | |
| Russian Federation | Site Management Organisation of Clinical Trials Centers | Smolensk | |
| Russian Federation | Tyumen State Medicine Academy | Tyumen | |
| Spain | 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 | Caceres | |
| Spain | Hospital Universitario Reina Sofia | Cordoba | |
| Spain | Ciutat Sanitaria I Universitaria de Bellvitge | Hospitalet de Llobregat | |
| Spain | Hospital General de Jerez de La Frontera | Jerez de La Frontera | |
| Spain | Complejo Universitario de San Carlos | Madrid | |
| Spain | Hospital de Merida | Merida | |
| 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 | |
| Sweden | ME3PLUS Clinical Trials | Goteborg | |
| Sweden | Njurmedicin, Sahlgrenska Univ.sjukhuset | Goteborg | |
| Sweden | Metabolmottagningen, Lasarettet, Kristianstad | Kristianstad | |
| Sweden | VO Endokrinologi/Diabetologi Universitetssjukhuset | Lund | |
| Sweden | Ladulaas Kliniska Studier | Skene |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Argentina, Australia, Canada, Costa Rica, Finland, France, Germany, India, Norway, Russian Federation, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment | 52 weeks | ||
| Secondary | 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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