Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ACZ885
ACZ885
Placebo
Placebo
Interventions
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ACZ885
Placebo
Eligibility Criteria
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Inclusion Criteria
* presence of at least one diabetes-related autoantibody
* qualifying C-peptide value in a mixed meal test at visit 1
* willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug
* body weight of at least 30 kg
Exclusion Criteria
* immunodeficiency
* active infections or febrile illness within 3 days before visit 1
* major dental work within 8 days before visit 1
* positive test for tuberculosis at visit 1
6 Years
35 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Aurora St Luke's Medical Center, Endocrine & Diabetes Center
Milwaukee, Wisconsin, United States
LMC Endocrinology Centres (Barrie) Ltd
Barrie, Ontario, Canada
LMC Endocrinology Centres (Bayview) Ltd
Toronto, Ontario, Canada
Novartis Investigative Site
Düsseldorf, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Neuwied, , Germany
Novartis Investigative Site
Bristol, , United Kingdom
Novartis Investigative Site
Exeter, , United Kingdom
Novartis Investigative Site
Hull, , United Kingdom
Novartis Investigative Site
Liverpool, , United Kingdom
Countries
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Other Identifiers
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2010-020166-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CACZ885I2208
Identifier Type: -
Identifier Source: org_study_id