Type 2 Diabetes
Conditions
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 ability of T2-18C3 to improve control of blood sugar levels in diabetics by blocking inflammation in the pancreas.
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 level of 1.25 mg/kg. These patients will be followed for a total of 90 days to examine safety, pharmacokinetics, and preliminary efficacy.
Interventions
DRUGT2-18C3 therapeutic antibody
1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 90 days | The safety and tolerability of T2-18C3 will be determined by observing patients for clinical adverse events, changes in vital signs, and changes in laboratory parameters such as hematology and chemistry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 90 days | Serum levels of T2-18C3 will be measured in patients |
| Preliminary Efficacy | 90 days | The ability of T2-18C3 to improve glycemic control will be measured by comparing the change in glycosylated hemoglobin levels of patients from baseline to day 90. |
Countries
Switzerland
Outcome results
None listed