Clinical trial NCT00513214 (phase 1/phase 2, status: completed)
Conditions: type 2 diabetes
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: xoma 052, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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 < 8.0 g/dL, WBC < 3.0 X 103/mm3, platelet count < 125 X 103/mm3, creatinine
             > 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