Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The study hypothesis is that XOMA 052 is likely to improve glycemic control in subjects with Type 2 Diabetes Mellitus. The purpose of this study is to determine whether XOMA 052 improves glycemic control in subjects on Metformin monotherapy whose diabetes is still not adequately controlled.

Official Title
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A Randomized Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: XOMA 052
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 uncontrolled hyperglycemia (i.e., polyuria, polydipsia, or polyphagia) Uncontrolled hypertension (systolic > 170 mmHg and/or diastolic > 110 mmHg) Known to be positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV History of allergic or anaphylactic reactions to humanized or murine monoclonal antibodies Advanced stage heart failure (New York Heart Association [NYHA] class 3 or 4) Pulmonary disease requiring medication other than inhaled corticosteroid s History of tuberculosis or positive PPD test. Active leg, foot, or decubitus ulcer Any significant inflammatory, rheumatologic, or systemic autoimmune disease History or any symptoms of a demyelinating disease History of severe non-proliferative or proliferative retinopathy Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: XOMA 052<br> | Drug: XOMA 052<br>* Sterile solution, dose level varies by dose group and study drug administration day, SC injections administered by study personnel at time points specified in the protocol (the subject will receive a total of 8 injections)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Type 2, Mellitus