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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00255645




Registration number
NCT00255645
Ethics application status
Date submitted
18/11/2005
Date registered
21/11/2005
Date last updated
17/03/2008

Titles & IDs
Public title
G-PLUS (GALLANT, GALLEX and ARMOR - Post Treatment Follow-up Study)
Scientific title
A Long-Term, Post-Treatment, Safety Follow-Up, Multi-Center Study in Patients With Type 2 Diabetes Mellitus From the GALLANT, GALLEX or ARMOR Studies.
Secondary ID [1] 0 0
EudraCT No 2005-001373-97
Secondary ID [2] 0 0
D6160C00056
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Provision of a written informed consent
* Men or women who either completed at least 6 months in a previous treatment study GALLANT, GALLEX or ARMOR or met a pre-defined laboratory or clinical finding during participation in any of the said studies.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received open-label treatment with tesaglitazar (since this is a post-treatment study)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Brisbane
Recruitment hospital [3] 0 0
Research Site - Cairns
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Research Site - Geelong
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Research Site - Melbourne
Recruitment hospital [6] 0 0
Research Site - Perth
Recruitment hospital [7] 0 0
Research Site - Sydney
Recruitment hospital [8] 0 0
Research Site - Tasmania
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Brisbane
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- Cairns
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- Geelong
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- Melbourne
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment postcode(s) [8] 0 0
- Tasmania
Recruitment outside Australia
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Alabama
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District of Columbia
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Michigan
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Nebraska
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North Carolina
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Utah
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Washington
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Nova Scotia
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Plzen
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Praha
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Semily
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Pori
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Salo
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Tampere
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Mars da Tour
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State/province [150] 0 0
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State/province [151] 0 0
Hannover
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Germany
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Heidelberg
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Germany
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Heilbronn
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Hermaringen
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Germany
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Künzing
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Germany
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Langen
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Germany
State/province [157] 0 0
Mannheim
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Germany
State/province [158] 0 0
Marl
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Germany
State/province [159] 0 0
Nürberg
Country [160] 0 0
Germany
State/province [160] 0 0
Pirna
Country [161] 0 0
Germany
State/province [161] 0 0
Rotenburg/Fulda
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Greece
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Athens
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Hong Kong
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Hong Kong
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Hong Kong
State/province [165] 0 0
Shatin, N.T.
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Budapest
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State/province [168] 0 0
Gy?r
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Hungary
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Kaposvár
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Hungary
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Kecskemét
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Siófok
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Székesfehérvár
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Bangalore
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India
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Mumbai
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Jakarta
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Malang
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Holon
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Tel Hashomer
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Israel
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Zefat
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Arenzano
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Italy
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Chiavari (GE)
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Messina
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Monteccio Emilia
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Napoli
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Padova
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Piacenza
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Pistoia
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Valmiera
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Huizen
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Losser
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Netherlands
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Netherlands
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Rijswijk
Country [234] 0 0
Netherlands
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Roelofarendsveen
Country [235] 0 0
Netherlands
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Rotterdam
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Norway
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Aurskog
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Norway
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Bergen
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Norway
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Elverum
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Norway
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Enebakk
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Norway
State/province [240] 0 0
Fredrikstad
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Norway
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Hamar
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Norway
State/province [242] 0 0
Haugesund
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Norway
State/province [243] 0 0
Horten
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Norway
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Hønefoss
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Norway
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Inderøy
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Norway
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Kongsberg
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Norway
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Larvik
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Norway
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Lena
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Norway
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Lierskogen
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Norway
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Lysaker
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Norway
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Oslo
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstrasZeneca Galida Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.