Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
NCT ID: NCT00998699
Last Updated: 2014-03-04
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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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2010-02-28
2013-08-31
Brief Summary
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The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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XOMA 052
Xoma 052
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Placebo
Placebo
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Interventions
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Xoma 052
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Placebo
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* No clinically significant change in treatment regimen for T1D
* Age ≥ 18 years and ≤ 55 years
* HbA1c \< 7.0%
* Positive GAD65 and/or IA-2 auto-antibodies
* Peak C-peptide \> 100 pM following IV injection of 1 mg glucagon
* Body-mass index (BMI) \> 18 and \< 28 kg/m2
* Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study
Exclusion Criteria
* Positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
* History of tuberculosis or positive PPD test
* Presence of foot, leg, or decubitus ulcers
* Current immunosuppressive treatment or documented immunodeficiency
* History of severe allergic or anaphylactic reactions
* History of asthma requiring systemic corticosteroid therapy
* Coronary intervention (PCI, stent placement) or hospitalization for cardiovascular condition within the last 12 months
* Uncontrolled hypertension
* History of congestive heart failure (NYHA Class III or IV)
* History of a coronary event within the last 12 months
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
* History of malignancy within the last 5 years
* Receipt of a live (attenuated) vaccine within the last 3 months
18 Years
55 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
XOMA (US) LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Donath, MD
Role: PRINCIPAL_INVESTIGATOR
UniversitaetsSpital Zuerich
Locations
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Basel, , Switzerland
Zurich, , Switzerland
Countries
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Other Identifiers
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X052076
Identifier Type: -
Identifier Source: org_study_id
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