safety and pharmacokinetics study of xoma 052 in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the safety and pharmacokinetics (pk) of xoma 052 in subjects with stable type 2 diabetes mellitus (t2d). the study is a dose-escalation study designed to evaluate route of administration (intravenous or subcutaneous), doses, and dosing regimens for future studies.


Eligibility criteria:
inclusion criteria: * american diabetes association (ada) diagnostic criteria for t2d - fasting blood glucose concentration ≥ 126 mg/dl (≥ 7.0 mmol/l) (must be measured within 35 days prior to day 0) or symptoms of hyperglycemia (e.g., thirst, polyuria, weight loss, visual blurring) and a casual/random plasma glucose value of ≥ 200 mg/dl (≥ 11.1 mmol/l) (must be measured within 35 days prior to day 0) * hba1c ≥ 7.5% and ≤ 12% (dcct standard) * current t2d of duration \> 6 months at screening * t2d and other diseases must be stable. stable disease is defined as disease that is judged stable by the investigator and which did not require a change in medications or dosing level on 4 or more consecutive days or 7 days in total within 35 days prior to day 0. * age ≥ 18 and ≤ 70 at screening * weight ≥ 80 lbs (36.3 kg) and ≤ 325 lbs (147.4 kg) * bmi ≥ 23 and ≤ 40 kg/m2 * for female subjects of child-bearing age, a negative serum pregnancy test. for subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study. * agree not to change diet and exercise regimen during the trial exclusion criteria: * use of the following medications - anti-inflammatory therapy other than aspirin ≤ 100 mg/day; immunosuppressive treatment; beta 2 and non-selective adrenergic blockers (note: selective beta 1 blockers are permitted); thiazolidinediones; glucagon-like peptide (glp) agonists including dpp4 inhibitors * change in medication for diabetes within 35 days prior to day 0, defined as a change in dosing level on 4 or more consecutive days or 7 days in total * fasting c-peptide \< 400 pm (\< 1.20 μg/l) * hemoglobin \ 1.5 mg/dl, ast/alt \> 2 x uln, alkaline phosphatase \> 2 x uln * positive for gad65 or ia-2 auto-antibodies * known hiv antibody, hepatitis b surface antigen, and/or hepatitis c antibody * history of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies * history of tuberculosis, positive ppd test, active atopic disease requiring medication, or asthma * infectious disease - crp \> 30 mg/l, fever, or infection requiring treatment with antibiotics within 3 weeks prior to screening; history of recurrent infection or predisposition to infection; active leg or foot ulcer * immunodeficiency * female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding * history or symptoms of a demyelinating disease * clinically significant diabetic macular edema and/or proliferative diabetic retinopathy by history or fundoscopy * receipt of a live (attenuated) vaccine within 3 months prior to screening * major surgery within 35 days prior to day 0 * participation in an investigational drug or device trial within 30 days prior to screening * use of a therapeutic monoclonal antibody within 90 days prior to screening * any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug

Keywords: diabetes type 2 mellitus