Type 1 DiabetesPhase 1/2NCT00730392
Etanercept in New Onset Type 1 Diabetes
A Phase 1/2 study testing Etanercept in people with Type 1 Diabetes, run by State University of New York at Buffalo.
Trial summary
The investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Etanercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Jan 2008
- Phase
- Phase 1/2
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females subjects with T1DM aged 3-18 years
- Positive GAD 65 and/or islet cell antibody
- HbA1c at diagnosis above 6%
- Insulin regimen with 3 injection of insulin daily (as described below)
- White blood count between 3,000-10,000 and platelets > 100,000
- Normal ALT and AST, creatinine < 1.8 mg/dl
- T1DM duration equal or less than 4 weeks
Who cannot join
- Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry
- BMI over 85th percentile for age and gender
- Unstable household
- Unable to provide compliance with study drug, insulin and study visits,
- Evidence of psychiatric disease in the potential study subject and/or primary care taker
- And chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis
About this study
Official title: "ENBREL® (Etanercept) Administration to Patients Newly Diagnosed With Type 1 Diabetes Mellitus: Feasibility-Safety Study" ("Study")
The investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.
Read the detailed description
This is a double-blind randomized 24-week placebo-controlled feasibility and safety study. Subjects received study drug for a 24- week period, followed by 4 and 12-week wash out periods.
- Conditions
- Type 1 Diabetes
- Being tested
- Etanercept, Placebo
- Keywords
- Type 1 diabetes, Etanercept, honeymoon period
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
The study drug was provided in lyophilized 10 mg vials to be reconstituted with 1 ml of diluent/vial and was administered at a dose of 0.4 mg/Kg up to maximum dose of 25 mg/dose SC twice weekly
PlaceboDrug
administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 drug, 2 placebo | Experimental | 1. Etanercept
2. Placebo Receives: Drug: Etanercept; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end points of this study are percent change from baseline for HbA1c and C-peptide area under the curve (AUC).
Measured: At baseline and at the end of the 24-week blind treatment
Secondary outcomes (1)
Secondary end points are insulin dose and number of insulin injection discontinued, if any
Measured: At baseline and at end of the 24-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startOct 2002
- Primary completionOct 2007
- Study completionJan 2008
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 1 DiabetesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Teresa Quattrin, State University of New York at Buffalo
- Investigators
- Teresa Quattrin, MD, Principal investigator, School of Medicine and Biochemical Sciences-SUNYAB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730392
- Sponsor's protocol ID
- 20020197
- Status last verified
- Apr 2023
- First submitted
- 5 Aug 2008
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mastrandrea L, Yu J, Behrens T, Buchlis J, Albini C, Fourtner S, Quattrin T. Etanercept treatment in children with new-onset type 1 diabetes: pilot randomized, placebo-controlled, double-blind study. Diabetes Care. 2009 Jul;32(7):1244-9. doi: 10.2337/dc09-0054. Epub 2009 Apr 14.
PubMed 19366957
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ENBREL® (Etanercept) Administration to Patients Newly Diagnosed With Type 1 Diabetes Mellitus: Feasibility-Safety Study" ("Study")
- ClinicalTrials.gov ID
- NCT00730392
- Acronym / sponsor ID
- 20020197
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Etanercept, honeymoon period
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Oct 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Aug 2008 (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 investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.
Detailed description
This is a double-blind randomized 24-week placebo-controlled feasibility and safety study. Subjects received study drug for a 24- week period, followed by 4 and 12-week wash out periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 drug, 2 placebo | Experimental | Drug: Etanercept, Drug: Placebo1. Etanercept 2. Placebo |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Males and females subjects with T1DM aged 3-18 years
- Positive GAD 65 and/or islet cell antibody
- HbA1c at diagnosis above 6%
- Insulin regimen with 3 injection of insulin daily (as described below)
- White blood count between 3,000-10,000 and platelets > 100,000
Key exclusion criteria (6 listed)
- Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry
- BMI over 85th percentile for age and gender
- Unstable household
- Unable to provide compliance with study drug, insulin and study visits,
- Evidence of psychiatric disease in the potential study subject and/or primary care taker
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 |
|---|---|---|
| EtanerceptThe study drug was provided in lyophilized 10 mg vials to be reconstituted with 1 ml of diluent/vial and was administered at a dose of 0.4 mg/Kg up to maximum dose of 25 mg/dose SC twice weekly | Drug | 1 drug, 2 placebo |
| Placeboadministered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly | Drug | 1 drug, 2 placebo |
Primary outcome
The primary end points of this study are percent change from baseline for HbA1c and C-peptide area under the curve (AUC).
Time frame: At baseline and at the end of the 24-week blind treatment
1 secondary outcome
Secondary end points are insulin dose and number of insulin injection discontinued, if any
Time frame: At baseline and at end of the 24-week treatment period
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 28 Apr 2023.
- Derived from this study: PubMed 19366957Mastrandrea L, Yu J, Behrens T, Buchlis J, Albini C, Fourtner S, Quattrin T. Etanercept treatment in children with new-onset type 1 diabetes: pilot randomized, placebo-controlled, double-blind study. Diabetes Care. 2009 Jul;32(7):1244-9. doi: 10.2337/dc09-0054. Epub 2009 Apr 14.
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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.
Teresa Quattrin, MD principal investigator
School of Medicine and Biochemical Sciences-SUNYAB
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Etanercept in people with Type 1 Diabetes, run by State University of New York at Buffalo.
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 7 inclusion and 6 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The primary end points of this study are percent change from baseline for HbA1c and C-peptide area under the curve (AUC). (time frame: At baseline and at the end of the 24-week blind treatment). 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 NCT00730392, 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 28 Apr 2023.