Type 2 DiabetesPhase 2NCT01427699
A Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes
A Phase 2 study testing T2-18C3 therapeutic antibody in people with Type 2 Diabetes, run by Janssen Research & Development, LLC at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- T2-18C3 therapeutic antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2011to 31 Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read 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 level of 1.25 mg/kg. These patients will be followed for a total of 90 days to examine safety, pharmacokinetics, and preliminary efficacy.
- Conditions
- Type 2 Diabetes
- Being tested
- T2-18C3 therapeutic antibody
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2-18C3 therapeutic antibodyDrug
1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| T2-18C3 therapeutic antibody | Experimental | 9 subjects will receive the T2-18C3 therapeutic antibody. Receives: Drug: T2-18C3 therapeutic antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (2)
Pharmacokinetics
Serum levels of T2-18C3 will be measured in patients
Measured: 90 days
Preliminary Efficacy
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study start30 Jun 2011
- Primary completion31 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427699
- Sponsor's protocol ID
- 2010-PT011
- Status last verified
- Feb 2021
- First submitted
- 31 Aug 2011
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26139558
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01427699
- Acronym / sponsor ID
- 2010-PT011
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2011 (actual)
- Primary completion
- 31 Oct 2012 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2-18C3 therapeutic antibody | Experimental | Drug: T2-18C3 therapeutic antibody9 subjects will receive the T2-18C3 therapeutic antibody. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- Use of the following medications:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2-18C3 therapeutic antibody1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses. | Drug | T2-18C3 therapeutic antibody |
Primary outcome
Safety and Tolerability
Time frame: 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.
2 secondary outcomes
Pharmacokinetics
Time frame: 90 days
Preliminary Efficacy
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 26139558Timper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T2-18C3 therapeutic antibody in people with Type 2 Diabetes, run by Janssen Research & Development, LLC at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01427699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.