Diabetes Mellitus, Type 2Phase 3NCT00765830
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
A Phase 3 study testing vildagliptin in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, run by Novartis at 90 sites in 12 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Renal Insufficiency
- What is being tested?
- vildagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 349 participants
- Where
- 90 sitesin 12 countries
- Study dates
- Sep 2008to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complete the core study
Who cannot join
- Did not comply with core study requirements
Trial locations and contacts
90 sites in 12 countries.
90 sites in 12 countries
Germany18 sites
Zentralklinikum Augsburg
Augsburg
Praxis Dr. Maxeiner
Bad Kreuznach
Universitaetsklinik Charitè
Berlin
Praxis Dr. Fischer
Darmstadt
Praxis Dr. Merker
Dormagen
Univ.-Klinikum Erlangen
Erlangen
Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann
Frankfurt
Universitätsklinikum Frankfurt
Frankfurt
Medizinische Hochschule Hannover
Hanover
Friedrich Schiller Universitaet Jena
Jena
CRS Clinical Research Services Gmbh
Kiel
I. Medizinische Univ.-Klinik
Kiel
Praxis Dr. Hennig
Meissen
Praxis Dr. Grimm
München
Univ.-Klinikum München, Campus Innenstadt
München
Praxis Dr. Schoell
Nuremberg
Forschungszentrum Ruhr, KliFoCenter GmbH
Witten
Universitaetsklinik im Luitpold-Krankenhaus
Würzburg
Spain14 sites
Clinica Mediterranea de Neurociencias
Alicante
Hospital de la Ribera
Alzira
Hospital Clinic I Provincial de Barcelona
Barcelona
Centro de Salud Begonte
Begonte
Hospital San Pedro de Alcantara
Cáceres
Hospital Universitario Reina Sofia
Córdoba
Hospital General de Jerez de La Frontera
Jerez de la Frontera
Ciutat Sanitaria I Universitaria de Bellvitge
L'Hospitalet de Llobregat
Complejo Universitario de San Carlos
Madrid
Hospital de Merida
Mérida
Hospital Son Dureta
Palma de Mallorca
Consorci Hospitalari Parc Tauli
Sabadell
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela
Eap El Remei - Vic
Vic
Russia11 sites
City Clinical Hospital #6
Chelyabinsk
City Clinical Hospital #1
Moscow
City Clinical Hospital No.11
Moscow
MSU of Medicine and Dentistry on the base of CityHospital 23
Moscow
MSUMD on the base of City Clinical Hospital #67
Moscow
City polyclinic # 17, City Diabetic Centre #3
Saint Petersburg
Krestovsky Island Medical Institute
Saint Petersburg
Saint- Petersburg State Mtchnikov's Medical Academy
Saint Petersburg
Saint-Petersburg State Pavlov's Medical University
Saint Petersburg
Site Management Organisation of Clinical Trials Centers
Smolensk
Tyumen State Medicine Academy
Tyumen
Canada8 sites
Co Medica Research Network Inc.
Courtice, Ontario
Centre de Recherche de Laval
Laval
Private Office (Gottesman)
Ontario
Ultra Med Inc.
Pointe-Claire, Quebec
Hopital Maisonneuve-Rosemont
Québec
ERS Endocrine Research Society
Vancouver, British Columbia
Health Sciences Centre - Diabetes Research Group
Winnipeg, Manitoba
Health Sciences Centre - Diabetes Research Group
Winnipeg
Argentina7 sites
Clinica de Fracturas y Ortopedia
Buenos Aires
Hospital Teodoro Alvarez
Buenos Aires
Instituto de Investigaciones Clinicas de Mar del Plata
Buenos Aires
Instituto Medico Especializado IME
Buenos Aires
Clinica Reina Fabiola
Córdoba
Hospital Juan Ramon Vidal
Corrientes
Hospital Zenon J. Santillan
San Miguel de Tucumán
France7 sites
Cabinet du Dr Arnou
Angers
Cabinet du Dr Giraud Philippe
Angers
Hôpital Docteur Duchenne
Boulogne-sur-Mer
Hopital Albert Michallon
Grenoble
Cabinet médical
Laval
Hopital Dupuytren
Limoges
Hopital Edouard Herriot
Lyon
India6 sites
Gujarat Endocrine Centre
Ahmedabad
M V Hospital for Diabetes and Diabetic Research Center
Chennai
Coimbatore Diabetes Foundation
Coimbatore
S.R. Kalla Memorial Gastro & General Hospital
Jaipur
Meenakshi Mission Hospital & Research Centre
Madurai
Diabetes Clinic & Research Centre
Nagpur
Australia5 sites
Heidelberg Repatriation Hospital
Heidelberg Heights
SA Endocrine Clinical Research
Keswick
Keogh Medical Research Institute
Nedlands Perth
St Vincent's Hospital (Melb)
Victoria
The Queen Elizabeth Hospital
Woodville, South Australia
Sweden5 sites
ME3PLUS Clinical Trials
Gothenburg
Njurmedicin, Sahlgrenska Univ.sjukhuset
Gothenburg
Metabolmottagningen, Lasarettet, Kristianstad
Kristianstad
VO Endokrinologi/Diabetologi Universitetssjukhuset
Lund
Ladulaas Kliniska Studier
Skene
Costa Rica4 sites
Clínica Vía San Juan
Cartago
Clínica de Endocrinología y Diabetes
San José
Clínica San Agustín
San José
Hospital Clínica Bíblica
San José
Finland3 sites
Satakunnan Keskussairaala
Pori
Mediwest Research Center
Seinäjoki
Tampereen lääkärikeskus Oy, Koskiklinikka
Tampere
Norway2 sites
Storoklinikken
Oslo
St. Olavs Hospital, Endokrinologisk seksjon
Trondheim
About this study
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
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
- Conditions
- Diabetes Mellitus, Type 2, Renal Insufficiency
- Being tested
- vildagliptin, Placebo
- Keywords
- Type 2 diabetes, vildagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vildagliptinDrug
50mg qd
PlaceboDrug
qd
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 50mg qd vildagliptin Receives: Drug: vildagliptin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment
Measured: 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
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765830
- Sponsor's protocol ID
- CLAF237A23137E1
- Status last verified
- Jan 2013
- First submitted
- 2 Oct 2008
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00765830
- Acronym / sponsor ID
- CLAF237A23137E1
- Conditions
- Diabetes Mellitus, Type 2, Renal Insufficiency
- Keywords
- Type 2 diabetes, vildagliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vildagliptin50mg qd vildagliptin |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Complete the core study
Key exclusion criteria (1 listed)
- Did not comply with core study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vildagliptin50mg qd | Drug | 1 |
| Placeboqd | Drug | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Results for CLAF237A23137E1 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
90 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vildagliptin in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, run by Novartis at 90 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in Germany, Spain, Russia, Canada, Argentina and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.