Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT01144975
Last Updated: 2012-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2010-05-31
2011-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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XOMA 052
XOMA 052
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)
Placebo
Placebo
Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)
Interventions
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XOMA 052
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)
Placebo
Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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XOMA (US) LLC
INDUSTRY
Responsible Party
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Locations
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Mexico City, , Mexico
Countries
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Other Identifiers
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X052118
Identifier Type: -
Identifier Source: org_study_id
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