Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
- Registration Number
- NCT01144975
- Lead Sponsor
- XOMA (US) LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XOMA 052 XOMA 052 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Anti-inflammatory activity measured by hs-CRP and cytokines collected at time points specified in the protocol. Day 0 pre-dose through Day 420 Pharmacokinetic assessments of XOMA 052 from serum samples 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