Clinical Trial Details
| Trial ID: | L6132 |
| Source ID: | NCT01144975 |
| Associated Drug: | Xoma 052 |
| Title: | Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: XOMA 052|DRUG: Placebo |
| Outcome Measures: | Primary: Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, daily fasting blood glucose measured by the subject using a glucose monitor, and treatment-emergent adverse events., Day 0 pre-dose through Day 420 | Secondary: Pharmacokinetic assessments of XOMA 052 from serum samples collected at time points specified in the protocol., Day 0 pre-dose through Day 420|Anti-inflammatory activity measured by hs-CRP and cytokines collected at time points specified in the protocol., Day 0 pre-dose through Day 420|Anti-diabetic activity measured by HbA1c, FPG, OGTT, C-peptide, and insulin collected at time points specified in the protocol., Day 0 pre-dose through Day 420 |
| Sponsor/Collaborators: | Sponsor: XOMA (US) LLC |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 76 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2010-05 |
| Completion Date: | 2011-10 |
| Results First Posted: | |
| Last Update Posted: | 2012-05-16 |
| Locations: | Mexico City, Mexico |
| URL: | https://clinicaltrials.gov/show/NCT01144975 |
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