Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
- Conditions
- Diabetes Mellitus, Type 2Renal Insufficiency
- Interventions
- Drug: Placebo
- Registration Number
- NCT00765830
- Lead Sponsor
- Novartis
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 349
- Complete the core study
- Did not comply with core study requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 vildagliptin 50mg qd vildagliptin 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment 52 weeks
- Secondary Outcome Measures
Name Time Method To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency 52 weeks
Trial Locations
- Locations (89)
Hospital de la Ribera
🇪🇸Alzira, Spain
Hospital San Pedro de Alcantara
🇪🇸Caceres, Spain
Clinica Mediterranea de Neurociencias
🇪🇸Alicante, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸Barcelona, Spain
Centro de Salud Begonte
🇪🇸Begonte, 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
Hospital Son Dureta
🇪🇸Palma De Mallorca, Spain
Complejo Universitario de San Carlos
🇪🇸Madrid, Spain
Hospital de Merida
🇪🇸Merida, 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
🇸🇪Goteborg, Sweden
Njurmedicin, Sahlgrenska Univ.sjukhuset
🇸🇪Goteborg, Sweden
Metabolmottagningen, Lasarettet, Kristianstad
🇸🇪Kristianstad, Sweden
Ladulaas Kliniska Studier
🇸🇪Skene, Sweden
VO Endokrinologi/Diabetologi Universitetssjukhuset
🇸🇪Lund, Sweden
Clinica de Fracturas y Ortopedia
🇦🇷Buenos Aires, Argentina
Hospital Juan Ramon Vidal
🇦🇷Corrientes, Argentina
Hospital Teodoro Alvarez
🇦🇷Buenos Aires, Argentina
Instituto Medico Especializado IME
🇦🇷Buenos Aires, Argentina
Hospital Zenon J. Santillan
🇦🇷San Miguel de Tucuman, Argentina
M V Hospital for Diabetes and Diabetic Research Center
🇮🇳Chennai, India
City Clinical Hospital No.11
🇷🇺Moscow, Russian Federation
Gujarat Endocrine Centre
🇮🇳Ahmedabad, India
Coimbatore Diabetes Foundation
🇮🇳Coimbatore, India
S.R. Kalla Memorial Gastro & General Hospital
🇮🇳Jaipur, India
City polyclinic # 17, City Diabetic Centre #3
🇷🇺Saint Petersburg, Russian Federation
Site Management Organisation of Clinical Trials Centers
🇷🇺Smolensk, Russian Federation
Krestovsky Island Medical Institute
🇷🇺Saint Petersburg, Russian Federation
Tyumen State Medicine Academy
🇷🇺Tyumen, Russian Federation
Clinica Reina Fabiola
🇦🇷Cordoba, Argentina
MSUMD on the base of City Clinical Hospital #67
🇷🇺Moscow, Russian Federation
Instituto de Investigaciones Clinicas de Mar del Plata
🇦🇷Buenos Aires, Argentina
Heidelberg Repatriation Hospital
🇦🇺Heidelberg Heights, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
St Vincent's Hospital (Melb)
🇦🇺Victoria, Australia
Keogh Medical Research Institute
🇦🇺Nedlands Perth, Australia
SA Endocrine Clinical Research
🇦🇺Keswick, Australia
ERS Endocrine Research Society
🇨🇦Vancouver, British Columbia, Canada
Co Medica Research Network Inc.
🇨🇦Courtice, Ontario, Canada
Health Sciences Centre - Diabetes Research Group
🇨🇦Winnipeg, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Quebec, Canada
Centre de Recherche de Laval
🇨🇦Laval, Canada
Ultra Med Inc.
🇨🇦Pointe-Claire, Quebec, Canada
Private Office (Gottesman)
🇨🇦Ontario, Canada
Clínica Vía San Juan
🇨🇷Cartago, Costa Rica
Clínica de Endocrinología y Diabetes
🇨🇷San Jose, Costa Rica
Hospital Clínica Bíblica
🇨🇷San Jose, Costa Rica
Clínica San Agustín
🇨🇷San Jose, Costa Rica
Satakunnan Keskussairaala
🇫🇮Pori, Finland
Mediwest Research Center
🇫🇮Seinajoki, Finland
Tampereen lääkärikeskus Oy, Koskiklinikka
🇫🇮Tampere, Finland
Cabinet du Dr Arnou
🇫🇷Angers, France
Hôpital Docteur Duchenne
🇫🇷Boulogne-sur-Mer, France
Cabinet du Dr Giraud Philippe
🇫🇷Angers, France
Cabinet médical
🇫🇷Laval, France
Hopital Albert Michallon
🇫🇷Grenoble cedex 9, France
Praxis Dr. Merker
🇩🇪Dormagen, Germany
Hopital Edouard Herriot
🇫🇷Lyon, France
Hopital Dupuytren
🇫🇷Limoges Cedex, France
Praxis Dr. Maxeiner
🇩🇪Bad Kreuznach, Germany
Zentralklinikum Augsburg
🇩🇪Augsburg, Germany
Univ.-Klinikum Erlangen
🇩🇪Erlangen, Germany
Praxis Dr. Fischer
🇩🇪Darmstadt, Germany
Universitaetsklinik Charitè
🇩🇪Berlin, Germany
Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann
🇩🇪Frankfurt, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, 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. Schoell
🇩🇪Nuernberg, Germany
Univ.-Klinikum München, Campus Innenstadt
🇩🇪München, Germany
Praxis Dr. Grimm
🇩🇪Muenchen, Germany
Forschungszentrum Ruhr, KliFoCenter GmbH
🇩🇪Witten, Germany
Universitaetsklinik im Luitpold-Krankenhaus
🇩🇪Wuerzburg, Germany
Meenakshi Mission Hospital & Research Centre
🇮🇳Madurai, India
Diabetes Clinic & Research Centre
🇮🇳Nagpur, India
Storoklinikken
🇳🇴Oslo, Norway
City Clinical Hospital #1
🇷🇺Moscow, Russian Federation
St. Olavs Hospital, Endokrinologisk seksjon
🇳🇴Trondheim, Norway
City Clinical Hospital #6
🇷🇺Chelyabinsk, Russian Federation
MSU of Medicine and Dentistry on the base of CityHospital 23
🇷🇺Moscow, Russian Federation
Saint-Petersburg State Pavlov's Medical University
🇷🇺Saint-Petersburg, Russian Federation
Saint- Petersburg State Mtchnikov's Medical Academy
🇷🇺Saint-Petersburg, Russian Federation