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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)
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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.
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Secondary ID [1]
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0
EudraCT No 2005-001373-97
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Secondary ID [2]
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D6160C00056
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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0
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Condition category
Condition code
Metabolic and Endocrine
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0
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Received open-label treatment with tesaglitazar (since this is a post-treatment study)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2006
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
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Recruitment hospital [1]
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Research Site - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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- Brisbane
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0
Germany
Query!
State/province [153]
0
0
Heilbronn
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Hermaringen
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Künzing
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Langen
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Mannheim
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Marl
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Nürberg
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Pirna
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Rotenburg/Fulda
Query!
Country [162]
0
0
Greece
Query!
State/province [162]
0
0
Athens
Query!
Country [163]
0
0
Greece
Query!
State/province [163]
0
0
Piraeus
Query!
Country [164]
0
0
Hong Kong
Query!
State/province [164]
0
0
Hong Kong
Query!
Country [165]
0
0
Hong Kong
Query!
State/province [165]
0
0
Shatin, N.T.
Query!
Country [166]
0
0
Hungary
Query!
State/province [166]
0
0
Balatonfüred
Query!
Country [167]
0
0
Hungary
Query!
State/province [167]
0
0
Budapest
Query!
Country [168]
0
0
Hungary
Query!
State/province [168]
0
0
Gy?r
Query!
Country [169]
0
0
Hungary
Query!
State/province [169]
0
0
Kaposvár
Query!
Country [170]
0
0
Hungary
Query!
State/province [170]
0
0
Kecskemét
Query!
Country [171]
0
0
Hungary
Query!
State/province [171]
0
0
Miskolc
Query!
Country [172]
0
0
Hungary
Query!
State/province [172]
0
0
Siófok
Query!
Country [173]
0
0
Hungary
Query!
State/province [173]
0
0
Székesfehérvár
Query!
Country [174]
0
0
India
Query!
State/province [174]
0
0
Bangalore
Query!
Country [175]
0
0
India
Query!
State/province [175]
0
0
Hyderabad
Query!
Country [176]
0
0
India
Query!
State/province [176]
0
0
Mumbai
Query!
Country [177]
0
0
India
Query!
State/province [177]
0
0
New Delhi
Query!
Country [178]
0
0
Indonesia
Query!
State/province [178]
0
0
Jakarta
Query!
Country [179]
0
0
Indonesia
Query!
State/province [179]
0
0
Malang
Query!
Country [180]
0
0
Israel
Query!
State/province [180]
0
0
Ashkelon
Query!
Country [181]
0
0
Israel
Query!
State/province [181]
0
0
Haifa
Query!
Country [182]
0
0
Israel
Query!
State/province [182]
0
0
Holon
Query!
Country [183]
0
0
Israel
Query!
State/province [183]
0
0
Jerusalem
Query!
Country [184]
0
0
Israel
Query!
State/province [184]
0
0
Rishon-Lezion
Query!
Country [185]
0
0
Israel
Query!
State/province [185]
0
0
Tel Aviv
Query!
Country [186]
0
0
Israel
Query!
State/province [186]
0
0
Tel Hashomer
Query!
Country [187]
0
0
Israel
Query!
State/province [187]
0
0
Zefat
Query!
Country [188]
0
0
Italy
Query!
State/province [188]
0
0
Arenzano
Query!
Country [189]
0
0
Italy
Query!
State/province [189]
0
0
Chiavari (GE)
Query!
Country [190]
0
0
Italy
Query!
State/province [190]
0
0
Chieri
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Firenze
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
Gubbio (PG)
Query!
Country [193]
0
0
Italy
Query!
State/province [193]
0
0
Messina
Query!
Country [194]
0
0
Italy
Query!
State/province [194]
0
0
Milano
Query!
Country [195]
0
0
Italy
Query!
State/province [195]
0
0
Monteccio Emilia
Query!
Country [196]
0
0
Italy
Query!
State/province [196]
0
0
Napoli
Query!
Country [197]
0
0
Italy
Query!
State/province [197]
0
0
Padova
Query!
Country [198]
0
0
Italy
Query!
State/province [198]
0
0
Perugia
Query!
Country [199]
0
0
Italy
Query!
State/province [199]
0
0
Pescara
Query!
Country [200]
0
0
Italy
Query!
State/province [200]
0
0
Piacenza
Query!
Country [201]
0
0
Italy
Query!
State/province [201]
0
0
Pistoia
Query!
Country [202]
0
0
Italy
Query!
State/province [202]
0
0
Reggio Calabria
Query!
Country [203]
0
0
Italy
Query!
State/province [203]
0
0
Reggio Emilia
Query!
Country [204]
0
0
Italy
Query!
State/province [204]
0
0
Roma
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
Scandiano
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
Udine
Query!
Country [207]
0
0
Korea, Republic of
Query!
State/province [207]
0
0
Seoul
Query!
Country [208]
0
0
Korea, Republic of
Query!
State/province [208]
0
0
Suwon
Query!
Country [209]
0
0
Latvia
Query!
State/province [209]
0
0
Daugavpils
Query!
Country [210]
0
0
Latvia
Query!
State/province [210]
0
0
Jekabpils
Query!
Country [211]
0
0
Latvia
Query!
State/province [211]
0
0
Madona
Query!
Country [212]
0
0
Latvia
Query!
State/province [212]
0
0
Riga
Query!
Country [213]
0
0
Latvia
Query!
State/province [213]
0
0
SIgulda
Query!
Country [214]
0
0
Latvia
Query!
State/province [214]
0
0
Talsi
Query!
Country [215]
0
0
Latvia
Query!
State/province [215]
0
0
Valmiera
Query!
Country [216]
0
0
Lithuania
Query!
State/province [216]
0
0
Vilnius
Query!
Country [217]
0
0
Malaysia
Query!
State/province [217]
0
0
Kuala Lumpur
Query!
Country [218]
0
0
Malaysia
Query!
State/province [218]
0
0
Kubang Kerian, Kota Bharu
Query!
Country [219]
0
0
Malaysia
Query!
State/province [219]
0
0
Penang
Query!
Country [220]
0
0
Mexico
Query!
State/province [220]
0
0
Guadalajara, Jalisco
Query!
Country [221]
0
0
Mexico
Query!
State/province [221]
0
0
México, D.F.
Query!
Country [222]
0
0
Mexico
Query!
State/province [222]
0
0
Nuevo León, Monterrey
Query!
Country [223]
0
0
Mexico
Query!
State/province [223]
0
0
Torreon
Query!
Country [224]
0
0
Mexico
Query!
State/province [224]
0
0
Veracruz, Veracruz
Query!
Country [225]
0
0
Mexico
Query!
State/province [225]
0
0
Zapopan , Jalisco
Query!
Country [226]
0
0
Netherlands
Query!
State/province [226]
0
0
Beek en Donk
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Bennebroek
Query!
Country [228]
0
0
Netherlands
Query!
State/province [228]
0
0
Den Haag
Query!
Country [229]
0
0
Netherlands
Query!
State/province [229]
0
0
Deurne
Query!
Country [230]
0
0
Netherlands
Query!
State/province [230]
0
0
Huizen
Query!
Country [231]
0
0
Netherlands
Query!
State/province [231]
0
0
Losser
Query!
Country [232]
0
0
Netherlands
Query!
State/province [232]
0
0
Nijverdal
Query!
Country [233]
0
0
Netherlands
Query!
State/province [233]
0
0
Rijswijk
Query!
Country [234]
0
0
Netherlands
Query!
State/province [234]
0
0
Roelofarendsveen
Query!
Country [235]
0
0
Netherlands
Query!
State/province [235]
0
0
Rotterdam
Query!
Country [236]
0
0
Norway
Query!
State/province [236]
0
0
Aurskog
Query!
Country [237]
0
0
Norway
Query!
State/province [237]
0
0
Bergen
Query!
Country [238]
0
0
Norway
Query!
State/province [238]
0
0
Elverum
Query!
Country [239]
0
0
Norway
Query!
State/province [239]
0
0
Enebakk
Query!
Country [240]
0
0
Norway
Query!
State/province [240]
0
0
Fredrikstad
Query!
Country [241]
0
0
Norway
Query!
State/province [241]
0
0
Hamar
Query!
Country [242]
0
0
Norway
Query!
State/province [242]
0
0
Haugesund
Query!
Country [243]
0
0
Norway
Query!
State/province [243]
0
0
Horten
Query!
Country [244]
0
0
Norway
Query!
State/province [244]
0
0
Hønefoss
Query!
Country [245]
0
0
Norway
Query!
State/province [245]
0
0
Inderøy
Query!
Country [246]
0
0
Norway
Query!
State/province [246]
0
0
Kongsberg
Query!
Country [247]
0
0
Norway
Query!
State/province [247]
0
0
Larvik
Query!
Country [248]
0
0
Norway
Query!
State/province [248]
0
0
Lena
Query!
Country [249]
0
0
Norway
Query!
State/province [249]
0
0
Lierskogen
Query!
Country [250]
0
0
Norway
Query!
State/province [250]
0
0
Lysaker
Query!
Country [251]
0
0
Norway
Query!
State/province [251]
0
0
Oslo
Query!
Country [252]
0
0
Norway
Query!
State/province [252]
0
0
Rolvsøy
Query!
Country [253]
0
0
Norway
Query!
State/province [253]
0
0
Rud
Query!
Country [254]
0
0
Norway
Query!
State/province [254]
0
0
Soerumsand
Query!
Country [255]
0
0
Norway
Query!
State/province [255]
0
0
Stavanger
Query!
Country [256]
0
0
Norway
Query!
State/province [256]
0
0
Straume
Query!
Country [257]
0
0
Norway
Query!
State/province [257]
0
0
Trondheim
Query!
Country [258]
0
0
Norway
Query!
State/province [258]
0
0
Ås
Query!
Country [259]
0
0
Norway
Query!
State/province [259]
0
0
Østerås
Query!
Country [260]
0
0
Philippines
Query!
State/province [260]
0
0
Cebu City
Query!
Country [261]
0
0
Philippines
Query!
State/province [261]
0
0
Makati
Query!
Country [262]
0
0
Philippines
Query!
State/province [262]
0
0
Manila
Query!
Country [263]
0
0
Philippines
Query!
State/province [263]
0
0
Marikina City
Query!
Country [264]
0
0
Philippines
Query!
State/province [264]
0
0
Pasig City
Query!
Country [265]
0
0
Philippines
Query!
State/province [265]
0
0
Quezon City
Query!
Country [266]
0
0
Poland
Query!
State/province [266]
0
0
Bialystok
Query!
Country [267]
0
0
Poland
Query!
State/province [267]
0
0
Bydgoszcz
Query!
Country [268]
0
0
Poland
Query!
State/province [268]
0
0
Gdansk
Query!
Country [269]
0
0
Poland
Query!
State/province [269]
0
0
Katowice - Ochojec
Query!
Country [270]
0
0
Poland
Query!
State/province [270]
0
0
Krakow
Query!
Country [271]
0
0
Poland
Query!
State/province [271]
0
0
Lodz
Query!
Country [272]
0
0
Poland
Query!
State/province [272]
0
0
Lublin
Query!
Country [273]
0
0
Poland
Query!
State/province [273]
0
0
Olsztyn
Query!
Country [274]
0
0
Poland
Query!
State/province [274]
0
0
Poznan
Query!
Country [275]
0
0
Poland
Query!
State/province [275]
0
0
P³ock
Query!
Country [276]
0
0
Poland
Query!
State/province [276]
0
0
Radom
Query!
Country [277]
0
0
Poland
Query!
State/province [277]
0
0
Rzeszow
Query!
Country [278]
0
0
Poland
Query!
State/province [278]
0
0
Sopot
Query!
Country [279]
0
0
Poland
Query!
State/province [279]
0
0
Szczecin
Query!
Country [280]
0
0
Poland
Query!
State/province [280]
0
0
Toruñ
Query!
Country [281]
0
0
Poland
Query!
State/province [281]
0
0
Tychy
Query!
Country [282]
0
0
Poland
Query!
State/province [282]
0
0
Warszawa
Query!
Country [283]
0
0
Poland
Query!
State/province [283]
0
0
Wroclaw
Query!
Country [284]
0
0
Poland
Query!
State/province [284]
0
0
Zielona Gora
Query!
Country [285]
0
0
Portugal
Query!
State/province [285]
0
0
Almada
Query!
Country [286]
0
0
Portugal
Query!
State/province [286]
0
0
Amadora
Query!
Country [287]
0
0
Portugal
Query!
State/province [287]
0
0
Elvas
Query!
Country [288]
0
0
Portugal
Query!
State/province [288]
0
0
Lisbon
Query!
Country [289]
0
0
Portugal
Query!
State/province [289]
0
0
Portalegre
Query!
Country [290]
0
0
Russian Federation
Query!
State/province [290]
0
0
Moscow
Query!
Country [291]
0
0
Russian Federation
Query!
State/province [291]
0
0
St. Petersburg
Query!
Country [292]
0
0
Russian Federation
Query!
State/province [292]
0
0
Yaroslavl
Query!
Country [293]
0
0
Singapore
Query!
State/province [293]
0
0
Singapore
Query!
Country [294]
0
0
Slovakia
Query!
State/province [294]
0
0
Bratislava
Query!
Country [295]
0
0
Slovakia
Query!
State/province [295]
0
0
Dolny Kubin
Query!
Country [296]
0
0
Slovakia
Query!
State/province [296]
0
0
Ilava
Query!
Country [297]
0
0
Slovakia
Query!
State/province [297]
0
0
Kosice
Query!
Country [298]
0
0
Slovakia
Query!
State/province [298]
0
0
Kysucke Nove Mesto
Query!
Country [299]
0
0
Slovakia
Query!
State/province [299]
0
0
Levice
Query!
Country [300]
0
0
Slovakia
Query!
State/province [300]
0
0
Lubochna
Query!
Country [301]
0
0
Slovakia
Query!
State/province [301]
0
0
Lucenec
Query!
Country [302]
0
0
Slovakia
Query!
State/province [302]
0
0
Nitra
Query!
Country [303]
0
0
Slovakia
Query!
State/province [303]
0
0
Nove Zamky
Query!
Country [304]
0
0
Slovakia
Query!
State/province [304]
0
0
Povazska Bystrica
Query!
Country [305]
0
0
Slovakia
Query!
State/province [305]
0
0
Presov
Query!
Country [306]
0
0
Slovakia
Query!
State/province [306]
0
0
Sahy
Query!
Country [307]
0
0
Slovakia
Query!
State/province [307]
0
0
Trencin
Query!
Country [308]
0
0
Slovakia
Query!
State/province [308]
0
0
Trnava
Query!
Country [309]
0
0
Slovakia
Query!
State/province [309]
0
0
Velky Meder
Query!
Country [310]
0
0
Slovakia
Query!
State/province [310]
0
0
Zilina
Query!
Country [311]
0
0
South Africa
Query!
State/province [311]
0
0
Cape Town
Query!
Country [312]
0
0
South Africa
Query!
State/province [312]
0
0
Chatsworth
Query!
Country [313]
0
0
South Africa
Query!
State/province [313]
0
0
Durban
Query!
Country [314]
0
0
South Africa
Query!
State/province [314]
0
0
Gauteng
Query!
Country [315]
0
0
South Africa
Query!
State/province [315]
0
0
Houghton Gauteng
Query!
Country [316]
0
0
South Africa
Query!
State/province [316]
0
0
Johannesburg
Query!
Country [317]
0
0
South Africa
Query!
State/province [317]
0
0
Pretoria
Query!
Country [318]
0
0
Spain
Query!
State/province [318]
0
0
Barcelona
Query!
Country [319]
0
0
Spain
Query!
State/province [319]
0
0
Begonte (Lugo)
Query!
Country [320]
0
0
Spain
Query!
State/province [320]
0
0
Guissona (Lleida)
Query!
Country [321]
0
0
Spain
Query!
State/province [321]
0
0
Madrid
Query!
Country [322]
0
0
Spain
Query!
State/province [322]
0
0
San Sebastian de los Reyes
Query!
Country [323]
0
0
Spain
Query!
State/province [323]
0
0
San Vicente de Raspeig (Alicante)
Query!
Country [324]
0
0
Spain
Query!
State/province [324]
0
0
Sevilla
Query!
Country [325]
0
0
Spain
Query!
State/province [325]
0
0
Valencia
Query!
Country [326]
0
0
Spain
Query!
State/province [326]
0
0
Villar del Arzobispo (Valencia)
Query!
Country [327]
0
0
Sweden
Query!
State/province [327]
0
0
Borås
Query!
Country [328]
0
0
Sweden
Query!
State/province [328]
0
0
Dalby
Query!
Country [329]
0
0
Sweden
Query!
State/province [329]
0
0
Göteborg
Query!
Country [330]
0
0
Sweden
Query!
State/province [330]
0
0
Höganäs
Query!
Country [331]
0
0
Sweden
Query!
State/province [331]
0
0
Malmö
Query!
Country [332]
0
0
Sweden
Query!
State/province [332]
0
0
Mölndal
Query!
Country [333]
0
0
Sweden
Query!
State/province [333]
0
0
Partille
Query!
Country [334]
0
0
Sweden
Query!
State/province [334]
0
0
Skene
Query!
Country [335]
0
0
Sweden
Query!
State/province [335]
0
0
Skrivarp
Query!
Country [336]
0
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Funding & Sponsors
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AstraZeneca
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00255645
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Principal investigator
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AstrasZeneca Galida Medical Science Director, MD
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AstraZeneca
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No information has been provided regarding IPD availability
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https://clinicaltrials.gov/study/NCT00255645
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