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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
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
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Research Site - Cairns
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Research Site - Geelong
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Research Site - Melbourne
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Research Site - Perth
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Research Site - Sydney
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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
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- Perth
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- Sydney
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- Tasmania
Recruitment outside Australia
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Tampere
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Künzing
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Mannheim
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Marl
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Pirna
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Athens
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Shatin, N.T.
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Gy?r
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Piacenza
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Pistoia
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Netherlands
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Roelofarendsveen
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Rotterdam
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Norway
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Norway
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Norway
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Elverum
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Norway
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Norway
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Fredrikstad
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Hamar
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Norway
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Haugesund
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Norway
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Horten
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Hønefoss
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Norway
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Kongsberg
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Larvik
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Lena
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Lysaker
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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
This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24
months, in patients with type 2 diabetes after participation in the phaseII/III studies
GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined
laboratory or clinical findings, will have a 12-week post-treatment follow-up visit,
including laboratory evaluation and adverse event recording.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00255645
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00255645