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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
349

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 clinicas 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
        • Hopital Albert Michallon
      • Laval, France
        • Cabinet Médical
      • Limoges Cedex, France
        • Hopital 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
        • Universitätsklinikum 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 Alcantara
      • 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 Taulí
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 2
Placebo
Drug: Placebo
qd
Experimental: 1
50mg qd vildagliptin
Drug: vildagliptin
50mg qd

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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