Status:
COMPLETED
Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
Lead Sponsor:
XOMA (US) LLC
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration. The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and in...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Stable Type 1 diabetes of \> 2 year duration
- 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:
- Current infection or history of infection
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00998699
Start Date
February 1 2010
End Date
August 1 2013
Last Update
March 4 2014
Active Locations (2)
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1
Basel, Switzerland
2
Zurich, Switzerland