Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

Study Overview
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Brief Summary
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The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2 Diabetes. Study X052078 is designed to establish efficacious dose(s) for future studies based on improvement in HbA1c.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of the Safety and Efficacy 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 ≥ 6.8% and ≤ 10.0% Have been on a stable regimen of metformin monotherapy for at least 12 weeks prior to Day 0 Willingness to maintain stable diet and exercise regime throughout the study Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study Exclusion Criteria: Uncontrolled hypertension History of malignancy within 5 years 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) Clinically significant uncontrolled arrhythmias History of tuberculosis Active leg, foot, or decubitus ulcer Any significant inflammatory, rheumatologic, or systemic autoimmune disease History of chronic infections History or any symptoms of a demyelinating disease Major surgery within 3 months Female subjects who are pregnant, planning to become pregnant 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Sterile solution subcutaneously administered monthly for 6 months<br>|
| Experimental: XOMA 052<br> | Drug: XOMA 052<br>* Sterile solution subcutaneously administered monthly for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182 |  | Day 0 pre-dose and Day 182 | 

Secondary 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 through Day 182 | 
| Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points |  | Day 0 pre-dose through Day 182 | 
| Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points |  | Day 0 pre-dose through Day 182 | 
| Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points |  | Day 0 pre-dose through Day 182 | 
| Serum levels of XOMA 052 (select sites only) |  | Day 28 pre-dose, Day 168 pre-dose, and Day 182 | 

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