| Trial ID: | L6932 |
| Source ID: | NCT00541983
|
| Associated Drug: |
Xoma 052
|
| Title: |
Single-dose, Dose-escalation Study of Safety, PK, and Preliminary Efficacy of XOMA 052 in Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: XOMA 052|DRUG: Placebo
|
| Outcome Measures: |
Primary: Glycated hemoglobin (HbA1c) at Days 0 and 28., Day 0 and Day 28 | Secondary: Pharmacokinetic assessments from serum samples collected at time points specified in the protocol., Dose groups 1 - 5: Day 0 pre-dose through Day 91. Dose group 6: Day 0 pre-dose through Day 364.|Safety assessed by adverse events, vital signs measurements, clinical laboratory assessments, infusion reactions, immune responses to XOMA 052., Dose groups 1 - 5: Day 0 pre-dose through Day 91. Dose group 6: Day 0 pre-dose through Day 364.|Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol., Dose groups 1 - 5: Day 0 pre-dose through Day 91. Dose group 6: Day 0 pre-dose through Day 364.
|
| Sponsor/Collaborators: |
Sponsor: XOMA (US) LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-09
|
| Completion Date: |
2010-02
|
| Results First Posted: |
|
| Last Update Posted: |
2010-05-04
|
| Locations: |
Covance Clinical Research (formerly Swiss Pharma Contract), Allschwil, Switzerland|Zurich, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00541983
|
