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XOMA 052

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |XOMA Royalty Corporation|Last Updated: Mar 4, 2014

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment497
FDA Designations
No designations recorded
Clinical trial landscape

XOMA 052 · 6 trials · 4 indications

Phase 2 4Phase 1 2
NCT01788033Effects of XOMA 052 on Insulin Production in Type 1 DiabetesDiabetes Mellitus Type 1
COMPLETED22 Analytics
NCT01144975Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes MellitusType 2 Diabetes Mellitus
COMPLETED76 Analytics
NCT00998699Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 DiabetesType 1 Diabetes
COMPLETED22 Analytics
NCT01066715Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin MonotherapyType 2 Diabetes Mellitus
COMPLETED421 Analytics
PHASE2COMPLETED
Effects of XOMA 052 on Insulin Production in Type 1 Diabetes
Diabetes Mellitus Type 1
NCT0178803322
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PHASE2COMPLETED
Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
NCT0114497576
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PHASE2COMPLETED
Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
Type 1 Diabetes
NCT0099869922
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PHASE2COMPLETED
Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
Type 2 Diabetes Mellitus
NCT01066715421
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Study Endpoints
Primary Endpoints
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
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
Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182
Day 0 pre-dose and Day 182
Glycated hemoglobin (HbA1c) at Days 0 and 28.
Day 0 and Day 28
Safety assessed by pre- and post-treatment serial measurements of vital signs.
Part 1: Day 0 pre-treatment through Day 56. Part 2: Day 0 pre-treatment through Day 56. Part 3: Day 0 pre-treatment through Day 84.
Safety assessed by treatment-emergent adverse events.
Part 1: Day 0 post-treatment through Day 56. Part 2: Day 0 post-treatment through Day 56. Part 3: Day 0 post-treatment through Day 84.
Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XOMA 052ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
1ACTIVE_COMPARATOR -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
XOMA 052DRUG0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
PlaceboDRUG0.3 mg/kg Placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
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Eligibility Criteria
Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed with T2D (disease duration \>= 6 months) * HbA1c measurements \>= 7.0% and \<= 10.0% * On a stable regimen of metformin monotherapy * Age \>= 18 and \<= 75 * Stable diet and exercise regimen * BMI \<= 40 kg/m2 Exclusion Criteria: * Significant signs and symptoms of...

Countries:SwitzerlandMexicoUnited States
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