Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
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
1 other identifier
interventional
349
12 countries
90
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Sep 2008
Longer than P75 for phase_3 diabetes-mellitus-type-2
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 2, 2008
CompletedFirst Posted
Study publicly available on registry
October 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedDecember 17, 2020
January 1, 2013
2.6 years
October 2, 2008
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment
52 weeks
Secondary Outcomes (1)
To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency
52 weeks
Study Arms (2)
1
EXPERIMENTAL50mg qd vildagliptin
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Complete the core study
You may not qualify if:
- Did not comply with core study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (90)
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
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2008
First Posted
October 3, 2008
Study Start
September 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
December 17, 2020
Record last verified: 2013-01