NCT01427699

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2012

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

August 31, 2011

Last Update Submit

February 17, 2021

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    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.

    90 days

Secondary Outcomes (2)

  • Pharmacokinetics

    90 days

  • Preliminary Efficacy

    90 days

Study Arms (1)

T2-18C3 therapeutic antibody

EXPERIMENTAL

9 subjects will receive the T2-18C3 therapeutic antibody.

Drug: T2-18C3 therapeutic antibody

Interventions

T2-18C3 therapeutic antibodyDRUG

1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.

T2-18C3 therapeutic antibody

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Basel

Basel, CH-4031, Switzerland

Location

Related Publications (1)

  • Timper K, Seelig E, Tsakiris DA, Donath MY. Safety, pharmacokinetics, and preliminary efficacy of a specific anti-IL-1alpha therapeutic antibody (MABp1) in patients with type 2 diabetes mellitus. J Diabetes Complications. 2015 Sep-Oct;29(7):955-60. doi: 10.1016/j.jdiacomp.2015.05.019. Epub 2015 Jun 3.

    PMID: 26139558DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 1, 2011

Study Start

June 30, 2011

Primary Completion

October 31, 2012

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

CH(1)