Status:
COMPLETED
A Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed 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 leve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01427699
Start Date
June 30 2011
Last Update
February 21 2021
Active Locations (1)
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1
University Hospital of Basel
Basel, Switzerland, CH-4031