A Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: T2-18C3 therapeutic antibody

Study type

Interventional

Funder types

Industry

Identifiers

NCT01427699

2010-PT011

Details and patient eligibility

About

The purpose of this study is to determine if T2-18C3, a true human monoclonal antibody that blocks inflammation, is safe to use in patients with type 2 diabetes. The study will also be looking at the ability of T2-18C3 to improve control of blood sugar levels in diabetics by blocking inflammation in the pancreas.

Full description

This is a phase I, open label study of the safety and pharmacokinetics of T2-18C3 in patients with T2D. Nine patients will receive four biweekly IV infusions of the study drug, T2-18C3, at a dose level of 1.25 mg/kg. These patients will be followed for a total of 90 days to examine safety, pharmacokinetics, and preliminary efficacy.

Enrollment

7 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

American Diabetes Association (ADA) diagnostic criteria for Type 2 Diabetes (T2D)
HbA1c >7.0% and ≤ 10%
Current T2D duration > 3 months at Screening
T2D and other diseases must be stable. Stable disease is defined as disease which did not require a change in medication or dosing level on 4 or more consecutive days or 7 days in total within 28 days prior to Day 0.
Age ≥ 18 and ≤ 70 at Screening
BMI ≥ 23 and ≤ 40 kg/m2
For female patients of child-bearing age, a negative serum pregnancy test. For patients with reproductive potential, a willingness to utilize adequate contraception (oral contraception plus a mechanical barrier) and not become pregnant (or have their partner[s] become pregnant) during the study
Agrees not to change diet and exercise regimen during the trial
Signed and dated Ethics Committee (EC) approved informed consent before any protocol-specific screening procedures are performed

Exclusion criteria

Use of the following medications:
- Daily use of steroids or aspirin ≥ 700 mg per week
- Immunosuppressive treatment
- Thiazolidinediones
- Concomitant treatment with any other therapeutic antibody, or treatment with any biologic agent that blocks the IL-1 or TNFα signaling pathway
Change in medication for diabetes within 28 days prior to Day 0, defined as a change in dosing level on 4 or more consecutive days or 7 days in total
Hemoglobin <10.0 g/dL, WBC <3.0 x 103/mm3 , platelet count <125 x 103/mm3, creatinine > 1.5mg/dL, AST/ALT >2 x ULN, alkaline phosphatase >2 x ULN
Abnormal, untreated T3, T4, thyroglobulin, or TSH levels or history of Grave's disease
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, nonmetastatic 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 patients who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
Receipt of a live (attenuated) vaccine within 3 months prior to Screening
Major surgery within 28 days prior to Day 0
Participation in an investigational drug or device trial within 30 days prior to Screening