Status:
COMPLETED
Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
XOMA (US) LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01144975
Start Date
May 1 2010
End Date
October 1 2011
Last Update
May 16 2012
Active Locations (1)
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1
Mexico City, Mexico