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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00765830
Other study ID # CLAF237A23137E1
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2008
Est. completion date April 2011

Study information

Verified date January 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
vildagliptin
50mg qd
Placebo
qd

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Argentina,  Australia,  Canada,  Costa Rica,  Finland,  France,  Germany,  India,  Norway,  Russian Federation,  Spain,  Sweden, 

Outcome

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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