Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
- Registration Number
- NCT01066715
- Lead Sponsor
- XOMA (US) LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 421
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - XOMA 052 XOMA 052 -
- Primary Outcome Measures
Name Time Method Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182 Day 0 pre-dose and Day 182
- Secondary 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 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