Type 1 Diabetes
Conditions
Keywords
Diabetes, Type 1
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 insulin production.
Interventions
DRUGXoma 052
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
DRUGPlacebo
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Sponsors
Juvenile Diabetes Research Foundation
XOMA (US) LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose) | Day 0 pre-dose and Day 112 |
Secondary
| Measure | Time frame |
|---|---|
| Change in insulin requirements | Day -3 through Day 0 pre-dose and Day 109 through Day 112) |
| Change in HbA1c levels | Day 0 pre-dose and Day 112 |
| Change in fasting glucose | Day 0 pre-dose and Day 112 |
| Change in fasting glucagon and cortisol | Day 0 pre-dose and Day 112 |
| Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events. | Day 0 (baseline) through Day 364 |
| Change in meal-stimulated GLP-1 and GIP | Day 0 pre-dose and Day 112 |
| Change in lipids profile | Day 0 pre-dose and Day 112 |
| Measurement of serum concentrations of XOMA 052 | Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364 |
| Change in systemic inflammation markers | Day 0 pre-dose and Day 112 |
Countries
Switzerland
Outcome results
None listed