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Diabetes Mellitus, Type 1Phase 1NCT00525889

Proleukin and Rapamune in Type 1 Diabetes

A Phase 1 study testing IL-2 and Rapamycin in people with Diabetes Mellitus, Type 1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. The study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
IL-2 and Rapamycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
3 sitesUnited States
Study dates
Aug 2007to Sep 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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosed with type 1 diabetes (per ADA criteria) more than 3 but less than 48 months prior to enrollment;
  • 18 to 45 years of age;and
  • Positive for at least one islet cell autoantibody (GAD65-antibody, CA512-antibody and/or ICA).

Who cannot join

  • Chronic use of glucocorticoids or other immunosuppressive ages 4 weeks before enrollment;
  • History of recurrent infections, other autoimmune diseases, cardiac disease, cataracts or other chronic medical conditions that investigators believe could compromise participant safety;
  • Females who are pregnant, lactating intend to get pregnant, or are unwilling to undergo pregnancy testing during the study;
  • Males who intend to father a pregnancy during the first 6 months of the study; or
  • Participation in another clinical study within the last 30 days.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Naomi Berrie Diabetes Center, Columbia University

    New York, New York, 10032

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Benaroya Research Institute

    Seattle, Washington, 98101

Other trials in United States

About this study

Official title: A Phase I Trial of Proleukin and Rapamune in Recent-onset Type 1 Diabetes Mellitus (ITN018AI)

This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. The study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes progression.

Read the detailed description

At the time of diagnosis with type 1 diabetes, 15-40% of beta cells may remain active and healthy in the pancreas, capable of producing insulin the body needs to regulate blood glucose levels. Because even small amounts of natural insulin production can decrease the long term effects of diabetes, it is essential that these cells are preserved.

This trial will test whether a combination of the drugs Proleukin (IL-2) and Rapamune (sirolimus) may be safely administered to recently diagnosed type 1 diabetes patients and whether it causes changes to the immune system that can halt the autoimmune destruction of the remaining beta cells. This drug combination has been found to be effective for long-term diabetes prevention in mouse models of type 1 diabetes.

This study is a phase I study for individuals 18-45 years of age who have been diagnosed with type 1 diabetes in the past 3-48 months. All participants will be treated with Proleukin (administered subcutaneously 3x per week) for 28 days and Rapamune (taken orally, daily) for 12 weeks. The study will last for 12 months, with additional follow-up of 24 months. The majority of study visits occur within the first 6 months. Mixed meal tolerance tests, in which participants take a milkshake-like drink and have blood sampled over a 2 or 4-hour period, will take place during an initial screening visit and three additional times during the first year. All participants will also receive intensive diabetes management designed to maintain stable blood glucose levels.

Being tested
IL-2, Rapamycin
Keywords
diabetes, juvenile diabetes, type 1 diabetes, diabetes mellitus, recent onset, new onset
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IL-2Drug

    Also called Proleukin

    Administered by subcutaneous injection at a dose of 4.5x10^6 IU/day, three times weekly for 28 days starting on day 0.

  • RapamycinDrug

    Also called Rapamune, Sirolimus

    Administered orally, initial daily dose of 2mg. At day 7, dose adjusted to achieve and maintain whole blood trough levels of 5-10 ng/ml.

Study groups in NCT00525889
Study groupRoleWhat they receive
Rapamycin/IL-2 combination therapyExperimentalIL-2 (Proleukin) was administered at 4.5 3 106 IU s.c., three times per week for 4 weeks for a total of 12 doses. Rapamycin (Rapamune or Sirolimus) was administered without a loading dose at 2 mg/day, with adjustments to maintain trough blood levels of 5-10 ng/mL for 3 months.
Receives: Drug: IL-2; Drug: Rapamycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events and laboratory anomalies

    Measured: through day 364

Secondary outcomes (4)

  1. AUC for C-peptide responses following MMTT

    Measured: various

  2. Frequency of severe hypoglycemia

    Measured: various

  3. Insulin dose in units per kilogram

    Measured: various

  4. HbA1c levels

    Measured: various

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionSep 2011
  4. Study completionSep 2013

Resources

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00525889
Sponsor's protocol ID
DAIT ITN018AI
Status last verified
Feb 2017
First submitted
4 Sep 2007
Last updated
8 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Publications

  • Long SA, Rieck M, Sanda S, Bollyky JB, Samuels PL, Goland R, Ahmann A, Rabinovitch A, Aggarwal S, Phippard D, Turka LA, Ehlers MR, Bianchine PJ, Boyle KD, Adah SA, Bluestone JA, Buckner JH, Greenbaum CJ; Diabetes TrialNet and the Immune Tolerance Network. Rapamycin/IL-2 combination therapy in patients with type 1 diabetes augments Tregs yet transiently impairs beta-cell function. Diabetes. 2012 Sep;61(9):2340-8. doi: 10.2337/db12-0049. Epub 2012 Jun 20.

    PubMed 22721971

  • Prevel N, Allenbach Y, Klatzmann D, Salomon B, Benveniste O. Beneficial role of rapamycin in experimental autoimmune myositis. PLoS One. 2013 Nov 12;8(11):e74450. doi: 10.1371/journal.pone.0074450. eCollection 2013.

    PubMed 24265670

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IL-2 and Rapamycin in people with Diabetes Mellitus, Type 1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites 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 3 inclusion and 5 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 adverse events and laboratory anomalies (time frame: through day 364). 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 NCT00525889, which also lists 2 linked publications.

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 8 Feb 2017.

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