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Clinical Trial Details

Trial ID: L6801
Source ID: NCT01788033
Associated Drug: Xoma 052
Title: Effects of XOMA 052 on Insulin Production in Type 1 Diabetes
Acronym: LATE STAGE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 1
Interventions: DRUG: XOMA 052|DRUG: Placebo
Outcome Measures: Primary: C-peptide level, incremental AUC over 120 minutes during the MMTT at Day 112 compared to baseline (Day 0 pre-dose | Secondary: Change in insulin requirements, 3-day average daily insulin dose at baseline (Day -3 through Day -1) compared to Day 112 (Day 109 through Day 111)|HbA1c levels, from baseline (Day 0 pre-dose) at Day 112|fasting glucose, from baseline (Day 0 pre-dose) at Day 112|fasting glucagon, from baseline (Day 0 pre-dose) at Day 112|cortisol, from baseline (Day 0 pre-dose) at Day 112|markers of systemic inflammation (Interleukin-6, Interleukin-8, Tumor Necrosis Factor α, hs-CRP), from baseline (Day 0 pre-dose) at Day 112|adipokines, from baseline (Day 0 pre-dose) at Day 112|meal-stimulated Glucagon like peptide-1, AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose)|meal-stimulated gastric inhibitory polypeptide, AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose)|lipids profile, from baseline (Day 0 pre-dose) at Day 112|Change in fatigue according to the Fatigue Scale for Motor and Cognitive Functions (FSMC) questionnaire, from baseline at Day 112|Anti XOMA 052 Antibodies, from baseline (Day 0 pre-dose) at Day 112|Number of Adverse Events, from baseline (Day 0 pre-dose) at Day 364
Sponsor/Collaborators: Sponsor: University of Zurich | Collaborators: XOMA (US) LLC
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-09
Completion Date: 2013-09
Results First Posted:
Last Update Posted: 2014-02-11
Locations: University Hospital Basel, Basel, 4031, Switzerland
URL: https://clinicaltrials.gov/show/NCT01788033