Clinical trial NCT00765830: Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Renal Insufficiency
Keywords: Type 2 diabetes, vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Complete the core study

Exclusion Criteria:

* Did not comply with core study requirements

Primary outcomes:
measure: To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment
timeFrame: 52 weeks
Secondary outcomes:
measure: To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Clinica de Fracturas y Ortopedia
city: Buenos Aires
country: Argentina
facility: Hospital Teodoro Alvarez
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas de Mar del Plata
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado IME
city: Cordoba
country: Argentina
facility: Clinica Reina Fabiola
city: Corrientes
country: Argentina
facility: Hospital Juan Ramon Vidal
city: San Miguel de Tucuman
country: Argentina
facility: Hospital Zenon J. Santillan
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Heidelberg Heights
country: Australia
facility: Heidelberg Repatriation Hospital
city: Keswick
country: Australia
facility: SA Endocrine Clinical Research
city: Nedlands Perth
country: Australia
facility: Keogh Medical Research Institute
city: Victoria
country: Australia
facility: St Vincent's Hospital (Melb)
city: Vancouver
country: Canada
facility: ERS Endocrine Research Society
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre - Diabetes Research Group
state: Manitoba
city: Courtice
country: Canada
facility: Co Medica Research Network Inc.
state: Ontario
city: Pointe-Claire
country: Canada
facility: Ultra Med Inc.
state: Quebec
city: Laval
country: Canada
facility: Centre de Recherche de Laval
city: Ontario
country: Canada
facility: Private Office (Gottesman)
city: Quebec
country: Canada
facility: Hopital Maisonneuve-Rosemont
city: Winnipeg
country: Canada
facility: Health Sciences Centre - Diabetes Research Group
city: Cartago
country: Costa Rica
facility: Clínica Vía San Juan
city: San Jose
country: Costa Rica
facility: Clínica de Endocrinología y Diabetes
city: San Jose
country: Costa Rica
facility: Clínica San Agustín
city: San Jose
country: Costa Rica
facility: Hospital Clínica Bíblica
city: Pori
country: Finland
facility: Satakunnan Keskussairaala
city: Seinajoki
country: Finland
facility: Mediwest Research Center
city: Tampere
country: Finland
facility: Tampereen lääkärikeskus Oy, Koskiklinikka
city: Angers
country: France
facility: Cabinet du Dr Arnou
city: Angers
country: France
facility: Cabinet du Dr Giraud Philippe
city: Boulogne-sur-Mer
country: France
facility: Hôpital Docteur Duchenne
city: Grenoble cedex 9
country: France
facility: Hopital Albert Michallon
city: Laval
country: France
facility: Cabinet médical
city: Limoges Cedex
country: France
facility: Hopital Dupuytren
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Augsburg
country: Germany
facility: Zentralklinikum Augsburg
city: Bad Kreuznach
country: Germany
facility: Praxis Dr. Maxeiner
city: Berlin
country: Germany
facility: Universitaetsklinik Charitè
city: Darmstadt
country: Germany
facility: Praxis Dr. Fischer
city: Dormagen
country: Germany
facility: Praxis Dr. Merker
city: Erlangen
country: Germany
facility: Univ.-Klinikum Erlangen
city: Frankfurt
country: Germany
facility: Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Friedrich Schiller Universitaet Jena
city: Kiel
country: Germany
facility: CRS Clinical Research Services Gmbh
city: Kiel
country: Germany
facility: I. Medizinische Univ.-Klinik
city: Meissen
country: Germany
facility: Praxis Dr. Hennig
city: Muenchen
country: Germany
facility: Praxis Dr. Grimm
city: München
country: Germany
facility: Univ.-Klinikum München, Campus Innenstadt
city: Nuernberg
country: Germany
facility: Praxis Dr. Schoell
city: Witten
country: Germany
facility: Forschungszentrum Ruhr, KliFoCenter GmbH
city: Wuerzburg
country: Germany
facility: Universitaetsklinik im Luitpold-Krankenhaus
city: Ahmedabad
country: India
facility: Gujarat Endocrine Centre
city: Chennai
country: India
facility: M V Hospital for Diabetes and Diabetic Research Center
city: Coimbatore
country: India
facility: Coimbatore Diabetes Foundation
city: Jaipur
country: India
facility: S.R. Kalla Memorial Gastro & General Hospital
city: Madurai
country: India
facility: Meenakshi Mission Hospital & Research Centre
city: Nagpur
country: India
facility: Diabetes Clinic & Research Centre
city: Oslo
country: Norway
facility: Storoklinikken
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Endokrinologisk seksjon
city: Chelyabinsk
country: Russian Federation
facility: City Clinical Hospital #6
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: City Clinical Hospital No.11
city: Moscow
country: Russian Federation
facility: MSU of Medicine and Dentistry on the base of CityHospital 23
city: Moscow
country: Russian Federation
facility: MSUMD on the base of City Clinical Hospital #67
city: Saint Petersburg
country: Russian Federation
facility: City polyclinic # 17, City Diabetic Centre #3
city: Saint Petersburg
country: Russian Federation
facility: Krestovsky Island Medical Institute
city: Saint-Petersburg
country: Russian Federation
facility: Saint- Petersburg State Mtchnikov's Medical Academy
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Pavlov's Medical University
city: Smolensk
country: Russian Federation
facility: Site Management Organisation of Clinical Trials Centers
city: Tyumen
country: Russian Federation
facility: Tyumen State Medicine Academy
city: Alicante
country: Spain
facility: Clinica Mediterranea de Neurociencias
city: Alzira
country: Spain
facility: Hospital de la Ribera
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Begonte
country: Spain
facility: Centro de Salud Begonte
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Hospitalet de Llobregat
country: Spain
facility: Ciutat Sanitaria I Universitaria de Bellvitge
city: Jerez de La Frontera
country: Spain
facility: Hospital General de Jerez de La Frontera
city: Madrid
country: Spain
facility: Complejo Universitario de San Carlos
city: Merida
country: Spain
facility: Hospital de Merida
city: Palma De Mallorca
country: Spain
facility: Hospital Son Dureta
city: Sabadell
country: Spain
facility: Consorci Hospitalari Parc Tauli
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
city: Vic
country: Spain
facility: Eap El Remei - Vic
city: Goteborg
country: Sweden
facility: ME3PLUS Clinical Trials
city: Goteborg
country: Sweden
facility: Njurmedicin, Sahlgrenska Univ.sjukhuset
city: Kristianstad
country: Sweden
facility: Metabolmottagningen, Lasarettet, Kristianstad
city: Lund
country: Sweden
facility: VO Endokrinologi/Diabetologi Universitetssjukhuset
city: Skene
country: Sweden
facility: Ladulaas Kliniska Studier
Study officials:
References: