Type 1 Diabetes MellitusPhase 1RID-ANCT00962026
Rilonacept in Diabetes Mellitus Type 1: Safety Study
A Phase 1 study testing Rilonacept in people with Type 1 Diabetes Mellitus, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study is being done to see if an investigational drug called rilonacept is safe to use in patients with type 1 diabetes, and if it can slow the loss of the body's ability to secrete insulin in patients who are still able to make a small amount of insulin. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Rilonacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2013
- Phase
- Phase 1
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Within 5 years of diagnosis of type 1 diabetes
- Between the ages of 16 to 45 years
- Have at least one diabetes-related autoantibody present
- Have mean C-peptide level > 0.2 nmol/L on a mixed meal tolerance test
- Be taking insulin
- Complete written informed consent
Who cannot join
- Taking inhaled or oral steroids (for example Advair, Orapred)
- Have an active infection
- Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
- Have ongoing use of medications known to affect glucose tolerance
- Have a live vaccine 90 days prior to, or during this study
- Taking any other experimental medication within the past 28 days
Show all 10Show fewer
- Have prior treatment with rilonacept
- Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
- Pregnant or lactating females
- Males and females unwilling to use an acceptable method of contraception for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus
This study is being done to see if an investigational drug called rilonacept is safe to use in patients with type 1 diabetes, and if it can slow the loss of the body's ability to secrete insulin in patients who are still able to make a small amount of insulin.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Rilonacept
- Keywords
- Interleukin 1, Type 1 diabetes mellitus, Rilonacept, Arcalyst
- 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.
RilonaceptDrug
Also called Arcalyst, IL-1 Trap
Rilonacept given subcutaneously, dose per package labeling, once weekly.
| Study group | Role | What they receive |
|---|---|---|
| Rilonacept | Experimental | Not described Receives: Drug: Rilonacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of infection in study participants
Measured: 7 months
Secondary outcomes (3)
Incidence and severity of other adverse effects in study participants
Measured: 7 months
Changes in participants' sex steroids (testosterone/estradiol)
Measured: 7 months
Changes in participants' HbA1c levels, insulin doses, and beta cell preservation
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startFeb 2011
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perrin C White, University of Texas Southwestern Medical Center
- Investigators
- Perrin C White, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962026
- Sponsor's protocol ID
- IL1T-AI-1022
- Acronym
- RID-A
- Status last verified
- Feb 2014
- First submitted
- 4 Aug 2009
- Last updated
- 24 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00962026
- Acronym / sponsor ID
- RID-A / IL1T-AI-1022
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Interleukin 1, Type 1 diabetes mellitus, Rilonacept, Arcalyst
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Aug 2009 (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.
This study is being done to see if an investigational drug called rilonacept is safe to use in patients with type 1 diabetes, and if it can slow the loss of the body's ability to secrete insulin in patients who are still able to make a small amount of insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rilonacept | Experimental | Drug: Rilonacept |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Within 5 years of diagnosis of type 1 diabetes
- Between the ages of 16 to 45 years
- Have at least one diabetes-related autoantibody present
- Have mean C-peptide level > 0.2 nmol/L on a mixed meal tolerance test
- Be taking insulin
Key exclusion criteria (10 listed)
- Taking inhaled or oral steroids (for example Advair, Orapred)
- Have an active infection
- Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
- Have ongoing use of medications known to affect glucose tolerance
- Have a live vaccine 90 days prior to, or during this study
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 |
|---|---|---|
| RilonaceptAlso: Arcalyst, IL-1 TrapRilonacept given subcutaneously, dose per package labeling, once weekly. | Drug | Rilonacept |
Primary outcome
Incidence and severity of infection in study participants
Time frame: 7 months
3 secondary outcomes
Incidence and severity of other adverse effects in study participants
Time frame: 7 months
Changes in participants' sex steroids (testosterone/estradiol)
Time frame: 7 months
Changes in participants' HbA1c levels, insulin doses, and beta cell preservation
Time frame: 7 months
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 24 Feb 2014.
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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.
Perrin C White, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rilonacept in people with Type 1 Diabetes Mellitus, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 6 inclusion and 10 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 24 Feb 2014. 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 United States. 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 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.
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?
Incidence and severity of infection in study participants (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2014.