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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XOMA 052 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XOMA 052 | Drug | 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) |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mexico City | Mexico |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C547697 | gevokizumab |
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| Placebo | Drug | Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections) |
|
| 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 |