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Clinical Trial Details

Trial ID: L5268
Source ID: NCT00998699
Associated Drug: Xoma 052
Title: Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Xoma 052|DRUG: Placebo
Outcome Measures: Primary: 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: 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 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|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|Measurement of serum concentrations of XOMA 052, Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364
Sponsor/Collaborators: Sponsor: XOMA (US) LLC | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-02
Completion Date: 2013-08
Results First Posted:
Last Update Posted: 2014-03-04
Locations: Basel, Switzerland|Zurich, Switzerland
URL: https://clinicaltrials.gov/show/NCT00998699