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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01427699
First received: August 31, 2011
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: T2-18C3 therapeutic antibody
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by XBiotech, Inc.:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Pharmacokinetics [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Serum levels of T2-18C3 will be measured in patients

  • Preliminary Efficacy [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 7
Study Start Date: June 2011
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T2-18C3 therapeutic antibody
9 subjects will receive the T2-18C3 therapeutic antibody.
Drug: T2-18C3 therapeutic antibody
1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427699

Locations
Switzerland
University Hospital of Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
XBiotech, Inc.
  More Information

No publications provided

Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT01427699     History of Changes
Other Study ID Numbers: 2010-PT011
Study First Received: August 31, 2011
Last Updated: October 29, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Inflammatory Agents
Antibodies
Immunoglobulins
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014