Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)

December 11, 2020 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Clinica de Fracturas y Ortopedia
      • Buenos Aires, Argentina
        • Hospital Teodoro Alvarez
      • Buenos Aires, Argentina
        • Instituto de Investigaciones Clínicas de Mar del Plata
      • Buenos Aires, Argentina
        • Instituto Medico Especializado IME
      • Cordoba, Argentina
        • Clinica Reina Fabiola
      • Corrientes, Argentina
        • Hospital Juan Ramon Vidal
      • San Miguel de Tucuman, Argentina
        • Hospital Zenon J. Santillan
  • Australia
      • Heidelberg Heights, Australia
        • Heidelberg Repatriation Hospital
      • Keswick, Australia
        • SA Endocrine Clinical Research
      • Nedlands Perth, Australia
        • Keogh Medical Research Institute
      • Victoria, Australia
        • St Vincent's Hospital (Melb)
    • South Australia
      • Woodville, South Australia, Australia
        • The Queen Elizabeth Hospital
  • Canada
      • Laval, Canada
        • Centre de Recherche de Laval
      • Ontario, Canada
        • Private Office (Gottesman)
      • Quebec, Canada
        • Hopital Maisonneuve-Rosemont
      • Winnipeg, Canada
        • Health Sciences Centre - Diabetes Research Group
    • British Columbia
      • Vancouver, British Columbia, Canada
        • ERS Endocrine Research Society
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Health Sciences Centre - Diabetes Research Group
    • Ontario
      • Courtice, Ontario, Canada
        • Co Medica Research Network Inc.
    • Quebec
      • Pointe-Claire, Quebec, Canada
        • Ultra Med Inc.
  • Costa Rica
      • Cartago, Costa Rica
        • Clínica Vía San Juan
      • San Jose, Costa Rica
        • Hospital Clínica Biblica
      • San Jose, Costa Rica
        • Clínica de Endocrinología y Diabetes
      • San Jose, Costa Rica
        • Clínica San Agustín
  • Finland
      • Pori, Finland
        • Satakunnan keskussairaala
      • Seinajoki, Finland
        • Mediwest Research Center
      • Tampere, Finland
        • Tampereen lääkärikeskus Oy, Koskiklinikka
  • France
      • Angers, France
        • Cabinet du Dr Arnou
      • Angers, France
        • Cabinet du Dr Giraud Philippe
      • Boulogne-sur-Mer, France
        • Hôpital Docteur Duchenne
      • Grenoble cedex 9, France
        • Hôpital Albert Michallon
      • Laval, France
        • Cabinet Médical
      • Limoges Cedex, France
        • Hôpital Dupuytren
      • Lyon, France
        • Hôpital Edouard Herriot
  • Germany
      • Augsburg, Germany
        • Zentralklinikum Augsburg
      • Bad Kreuznach, Germany
        • Praxis Dr. Maxeiner
      • Berlin, Germany
        • Universitaetsklinik Charite
      • Darmstadt, Germany
        • Praxis Dr. Fischer
      • Dormagen, Germany
        • Praxis Dr. Merker
      • Erlangen, Germany
        • Univ.-Klinikum Erlangen
      • Frankfurt, Germany
        • Universitatsklinikum Frankfurt
      • Frankfurt, Germany
        • Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Jena, Germany
        • Friedrich Schiller Universitaet Jena
      • Kiel, Germany
        • CRS Clinical Research Services Gmbh
      • Kiel, Germany
        • I. Medizinische Univ.-Klinik
      • Meissen, Germany
        • Praxis Dr. Hennig
      • Muenchen, Germany
        • Praxis Dr. Grimm
      • München, Germany
        • Univ.-Klinikum München, Campus Innenstadt
      • Nuernberg, Germany
        • Praxis Dr. Schoell
      • Witten, Germany
        • Forschungszentrum Ruhr, KliFoCenter GmbH
      • Wuerzburg, Germany
        • Universitaetsklinik im Luitpold-Krankenhaus
  • India
      • Ahmedabad, India
        • Gujarat Endocrine Centre
      • Chennai, India
        • M V Hospital for Diabetes and Diabetic Research Center
      • Coimbatore, India
        • Coimbatore Diabetes Foundation
      • Jaipur, India
        • S.R. Kalla Memorial Gastro & General Hospital
      • Madurai, India
        • Meenakshi Mission Hospital & Research Centre
      • Nagpur, India
        • Diabetes Clinic & Research Centre
  • Norway
      • Oslo, Norway
        • Storoklinikken
      • Trondheim, Norway
        • St. Olavs Hospital, Endokrinologisk seksjon
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • City Clinical Hospital #6
      • Moscow, 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
      • Saint Petersburg, Russian Federation
        • Krestovsky Island Medical Institute
      • Saint Petersburg, Russian Federation
        • City polyclinic # 17, City Diabetic Centre #3
      • Saint-Petersburg, Russian Federation
        • Saint- Petersburg State Mtchnikov's Medical Academy
      • Saint-Petersburg, Russian Federation
        • Saint-Petersburg State Pavlov's Medical University
      • Smolensk, Russian Federation
        • Site Management Organisation of Clinical Trials Centers
      • Tyumen, Russian Federation
        • Tyumen State Medicine Academy
  • Spain
      • Alicante, Spain
        • Clinica Mediterranea de Neurociencias
      • Alzira, Spain
        • Hospital de La Ribera
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona
      • Begonte, Spain
        • Centro de Salud Begonte
      • Caceres, Spain
        • Hospital San Pedro de Alcántara
      • Cordoba, Spain
        • Hospital Universitario Reina Sofia
      • Hospitalet de Llobregat, Spain
        • Ciutat Sanitaria i Universitaria de Bellvitge
      • Jerez de La Frontera, Spain
        • Hospital general de Jerez de la Frontera
      • Madrid, Spain
        • Complejo Universitario de San Carlos
      • Merida, Spain
        • Hospital de Mérida
      • Palma De Mallorca, Spain
        • Hospital Son Dureta
      • Sabadell, Spain
        • Consorci Hospitalari Parc Tauli
      • Santiago de Compostela, Spain
        • Hospital Clinico Universitario Santiago de Compostela
      • Vic, Spain
        • Eap El Remei - Vic
  • Sweden
      • Goteborg, Sweden
        • ME3PLUS Clinical Trials
      • Goteborg, Sweden
        • Njurmedicin, Sahlgrenska Univ.sjukhuset
      • Kristianstad, Sweden
        • Metabolmottagningen, Lasarettet, Kristianstad
      • Lund, Sweden
        • VO Endokrinologi/Diabetologi Universitetssjukhuset
      • Skene, Sweden
        • Ladulaas Kliniska Studier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complete the core study

Exclusion Criteria:

  • Did not comply with core study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
qd
Experimental: 1
50mg qd vildagliptin
Drug: vildagliptin
50mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A23137E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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