Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

XOMA

Status and phase

Completed

Phase 2

Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: Placebo

Drug: XOMA 052

Study type

Interventional

Funder types

Industry

Identifiers

NCT00513214

X052073

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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