Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
- Registration Number
- NCT00998699
- Lead Sponsor
- XOMA (US) LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XOMA 052 Xoma 052 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in HbA1c levels Day 0 pre-dose and Day 112 Change in systemic inflammation markers Day 0 pre-dose and Day 112 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 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 insulin requirements Day -3 through Day 0 pre-dose and Day 109 through 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 Measurement of serum concentrations of XOMA 052 Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364