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

Primary Purpose

Diabetes Mellitus, Type 2, Renal Insufficiency

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
vildagliptin
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, vildagliptin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complete the core study

Exclusion Criteria:

  • Did not comply with core study requirements

Sites / Locations

  • Clinica de Fracturas y Ortopedia
  • Hospital Teodoro Alvarez
  • Instituto de Investigaciones Clinicas de Mar del Plata
  • Instituto Medico Especializado IME
  • Clinica Reina Fabiola
  • Hospital Juan Ramon Vidal
  • Hospital Zenon J. Santillan
  • The Queen Elizabeth Hospital
  • Heidelberg Repatriation Hospital
  • SA Endocrine Clinical Research
  • Keogh Medical Research Institute
  • St Vincent's Hospital (Melb)
  • ERS Endocrine Research Society
  • Health Sciences Centre - Diabetes Research Group
  • Co Medica Research Network Inc.
  • Ultra Med Inc.
  • Centre de Recherche de Laval
  • Private Office (Gottesman)
  • Hopital Maisonneuve-Rosemont
  • Health Sciences Centre - Diabetes Research Group
  • Clínica Vía San Juan
  • Clínica de Endocrinología y Diabetes
  • Clínica San Agustín
  • Hospital Clínica Bíblica
  • Satakunnan Keskussairaala
  • Mediwest Research Center
  • Tampereen lääkärikeskus Oy, Koskiklinikka
  • Cabinet du Dr Arnou
  • Cabinet du Dr Giraud Philippe
  • Hôpital Docteur Duchenne
  • Hopital Albert Michallon
  • Cabinet médical
  • Hopital Dupuytren
  • Hopital Edouard Herriot
  • Zentralklinikum Augsburg
  • Praxis Dr. Maxeiner
  • Universitaetsklinik Charitè
  • Praxis Dr. Fischer
  • Praxis Dr. Merker
  • Univ.-Klinikum Erlangen
  • Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann
  • Universitätsklinikum Frankfurt
  • Medizinische Hochschule Hannover
  • Friedrich Schiller Universitaet Jena
  • CRS Clinical Research Services Gmbh
  • I. Medizinische Univ.-Klinik
  • Praxis Dr. Hennig
  • Praxis Dr. Grimm
  • Univ.-Klinikum München, Campus Innenstadt
  • Praxis Dr. Schoell
  • Forschungszentrum Ruhr, KliFoCenter GmbH
  • Universitaetsklinik im Luitpold-Krankenhaus
  • Gujarat Endocrine Centre
  • M V Hospital for Diabetes and Diabetic Research Center
  • Coimbatore Diabetes Foundation
  • S.R. Kalla Memorial Gastro & General Hospital
  • Meenakshi Mission Hospital & Research Centre
  • Diabetes Clinic & Research Centre
  • Storoklinikken
  • St. Olavs Hospital, Endokrinologisk seksjon
  • City Clinical Hospital #6
  • City Clinical Hospital #1
  • City Clinical Hospital No.11
  • MSU of Medicine and Dentistry on the base of CityHospital 23
  • MSUMD on the base of City Clinical Hospital #67
  • City polyclinic # 17, City Diabetic Centre #3
  • Krestovsky Island Medical Institute
  • Saint- Petersburg State Mtchnikov's Medical Academy
  • Saint-Petersburg State Pavlov's Medical University
  • Site Management Organisation of Clinical Trials Centers
  • Tyumen State Medicine Academy
  • Clinica Mediterranea de Neurociencias
  • Hospital de la Ribera
  • Hospital Clinic I Provincial de Barcelona
  • Centro de Salud Begonte
  • Hospital San Pedro de Alcantara
  • Hospital Universitario Reina Sofia
  • Ciutat Sanitaria I Universitaria de Bellvitge
  • Hospital General de Jerez de La Frontera
  • Complejo Universitario de San Carlos
  • Hospital de Merida
  • Hospital Son Dureta
  • Consorci Hospitalari Parc Tauli
  • Hospital Clinico Universitario Santiago de Compostela
  • Eap El Remei - Vic
  • ME3PLUS Clinical Trials
  • Njurmedicin, Sahlgrenska Univ.sjukhuset
  • Metabolmottagningen, Lasarettet, Kristianstad
  • VO Endokrinologi/Diabetologi Universitetssjukhuset
  • Ladulaas Kliniska Studier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

50mg qd vildagliptin

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency

Full Information

First Posted
October 2, 2008
Last Updated
December 11, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00765830
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Renal Insufficiency
Keywords
Type 2 diabetes, vildagliptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
50mg qd vildagliptin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Intervention Description
50mg qd
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
qd
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complete the core study Exclusion Criteria: Did not comply with core study requirements
Facility Information:
Facility Name
Clinica de Fracturas y Ortopedia
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Teodoro Alvarez
City
Buenos Aires
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas de Mar del Plata
City
Buenos Aires
Country
Argentina
Facility Name
Instituto Medico Especializado IME
City
Buenos Aires
Country
Argentina
Facility Name
Clinica Reina Fabiola
City
Cordoba
Country
Argentina
Facility Name
Hospital Juan Ramon Vidal
City
Corrientes
Country
Argentina
Facility Name
Hospital Zenon J. Santillan
City
San Miguel de Tucuman
Country
Argentina
Facility Name
The Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
Country
Australia
Facility Name
Heidelberg Repatriation Hospital
City
Heidelberg Heights
Country
Australia
Facility Name
SA Endocrine Clinical Research
City
Keswick
Country
Australia
Facility Name
Keogh Medical Research Institute
City
Nedlands Perth
Country
Australia
Facility Name
St Vincent's Hospital (Melb)
City
Victoria
Country
Australia
Facility Name
ERS Endocrine Research Society
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Health Sciences Centre - Diabetes Research Group
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Co Medica Research Network Inc.
City
Courtice
State/Province
Ontario
Country
Canada
Facility Name
Ultra Med Inc.
City
Pointe-Claire
State/Province
Quebec
Country
Canada
Facility Name
Centre de Recherche de Laval
City
Laval
Country
Canada
Facility Name
Private Office (Gottesman)
City
Ontario
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Quebec
Country
Canada
Facility Name
Health Sciences Centre - Diabetes Research Group
City
Winnipeg
Country
Canada
Facility Name
Clínica Vía San Juan
City
Cartago
Country
Costa Rica
Facility Name
Clínica de Endocrinología y Diabetes
City
San Jose
Country
Costa Rica
Facility Name
Clínica San Agustín
City
San Jose
Country
Costa Rica
Facility Name
Hospital Clínica Bíblica
City
San Jose
Country
Costa Rica
Facility Name
Satakunnan Keskussairaala
City
Pori
Country
Finland
Facility Name
Mediwest Research Center
City
Seinajoki
Country
Finland
Facility Name
Tampereen lääkärikeskus Oy, Koskiklinikka
City
Tampere
Country
Finland
Facility Name
Cabinet du Dr Arnou
City
Angers
Country
France
Facility Name
Cabinet du Dr Giraud Philippe
City
Angers
Country
France
Facility Name
Hôpital Docteur Duchenne
City
Boulogne-sur-Mer
Country
France
Facility Name
Hopital Albert Michallon
City
Grenoble cedex 9
Country
France
Facility Name
Cabinet médical
City
Laval
Country
France
Facility Name
Hopital Dupuytren
City
Limoges Cedex
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
Country
France
Facility Name
Zentralklinikum Augsburg
City
Augsburg
Country
Germany
Facility Name
Praxis Dr. Maxeiner
City
Bad Kreuznach
Country
Germany
Facility Name
Universitaetsklinik Charitè
City
Berlin
Country
Germany
Facility Name
Praxis Dr. Fischer
City
Darmstadt
Country
Germany
Facility Name
Praxis Dr. Merker
City
Dormagen
Country
Germany
Facility Name
Univ.-Klinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann
City
Frankfurt
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Friedrich Schiller Universitaet Jena
City
Jena
Country
Germany
Facility Name
CRS Clinical Research Services Gmbh
City
Kiel
Country
Germany
Facility Name
I. Medizinische Univ.-Klinik
City
Kiel
Country
Germany
Facility Name
Praxis Dr. Hennig
City
Meissen
Country
Germany
Facility Name
Praxis Dr. Grimm
City
Muenchen
Country
Germany
Facility Name
Univ.-Klinikum München, Campus Innenstadt
City
München
Country
Germany
Facility Name
Praxis Dr. Schoell
City
Nuernberg
Country
Germany
Facility Name
Forschungszentrum Ruhr, KliFoCenter GmbH
City
Witten
Country
Germany
Facility Name
Universitaetsklinik im Luitpold-Krankenhaus
City
Wuerzburg
Country
Germany
Facility Name
Gujarat Endocrine Centre
City
Ahmedabad
Country
India
Facility Name
M V Hospital for Diabetes and Diabetic Research Center
City
Chennai
Country
India
Facility Name
Coimbatore Diabetes Foundation
City
Coimbatore
Country
India
Facility Name
S.R. Kalla Memorial Gastro & General Hospital
City
Jaipur
Country
India
Facility Name
Meenakshi Mission Hospital & Research Centre
City
Madurai
Country
India
Facility Name
Diabetes Clinic & Research Centre
City
Nagpur
Country
India
Facility Name
Storoklinikken
City
Oslo
Country
Norway
Facility Name
St. Olavs Hospital, Endokrinologisk seksjon
City
Trondheim
Country
Norway
Facility Name
City Clinical Hospital #6
City
Chelyabinsk
Country
Russian Federation
Facility Name
City Clinical Hospital #1
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital No.11
City
Moscow
Country
Russian Federation
Facility Name
MSU of Medicine and Dentistry on the base of CityHospital 23
City
Moscow
Country
Russian Federation
Facility Name
MSUMD on the base of City Clinical Hospital #67
City
Moscow
Country
Russian Federation
Facility Name
City polyclinic # 17, City Diabetic Centre #3
City
Saint Petersburg
Country
Russian Federation
Facility Name
Krestovsky Island Medical Institute
City
Saint Petersburg
Country
Russian Federation
Facility Name
Saint- Petersburg State Mtchnikov's Medical Academy
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Saint-Petersburg State Pavlov's Medical University
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Site Management Organisation of Clinical Trials Centers
City
Smolensk
Country
Russian Federation
Facility Name
Tyumen State Medicine Academy
City
Tyumen
Country
Russian Federation
Facility Name
Clinica Mediterranea de Neurociencias
City
Alicante
Country
Spain
Facility Name
Hospital de la Ribera
City
Alzira
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Centro de Salud Begonte
City
Begonte
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
Country
Spain
Facility Name
Ciutat Sanitaria I Universitaria de Bellvitge
City
Hospitalet de Llobregat
Country
Spain
Facility Name
Hospital General de Jerez de La Frontera
City
Jerez de La Frontera
Country
Spain
Facility Name
Complejo Universitario de San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital de Merida
City
Merida
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma De Mallorca
Country
Spain
Facility Name
Consorci Hospitalari Parc Tauli
City
Sabadell
Country
Spain
Facility Name
Hospital Clinico Universitario Santiago de Compostela
City
Santiago de Compostela
Country
Spain
Facility Name
Eap El Remei - Vic
City
Vic
Country
Spain
Facility Name
ME3PLUS Clinical Trials
City
Goteborg
Country
Sweden
Facility Name
Njurmedicin, Sahlgrenska Univ.sjukhuset
City
Goteborg
Country
Sweden
Facility Name
Metabolmottagningen, Lasarettet, Kristianstad
City
Kristianstad
Country
Sweden
Facility Name
VO Endokrinologi/Diabetologi Universitetssjukhuset
City
Lund
Country
Sweden
Facility Name
Ladulaas Kliniska Studier
City
Skene
Country
Sweden

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5924
Description
Results for CLAF237A23137E1 from the Novartis Clinical Trials website

Learn more about this trial

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

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