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Insulin-Dependent Diabetes MellitusPhase 2NCT00024518

Interferon-Alpha for Diabetes Mellitus Type 1

A Phase 2 study testing 30,000 units hrINF-alpha and 5,000 hrINF-alpha in people with Insulin-Dependent Diabetes Mellitus, run by The University of Texas Health Science Center, Houston at 5 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 study will see if interferon-alpha given early in the disease can stop or slow the immune attack on insulin-producing cells. In addition, the study will examine the safety and efficacy of interferon-alpha (given by mouth) to protect beta cell function. Read more about this study

Who is it for?
Ages 3 to 25 years
Conditions the study is for
Insulin-Dependent Diabetes Mellitus
What is being tested?
30,000 units hrINF-alpha and 5,000 hrINF-alpha
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
5 sitesUnited States
Study dates
Sep 2001to Sep 2008
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 3 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • T1DM of less than 6 weeks duration in patients between 3 and 25 years of age.
  • Besides T1DM, no concurrent illness.

Who cannot join

  • Treatment with immunosuppressive or immunostimulatory medications such as azathioprine, nicotinamide, superoxide dismutase-desferroxamine, aminoguanidine, oral insulin or other experimental therapies at the present time or in the past.
  • Abnormal pre-treatment white blood cell count (WBC) or thrombocytopenia.
  • Known active diseases, e.g. cardiac, renal, hepatic diseases or immunodeficiency.
  • History of cancer, neuropathy seizure disorders (except typical history of febrile seizures in childhood), peripheral vascular disease, coagulation abnormalities, autoimmune disease (except type 1 diabetes) or cerebrovascular disease.
  • Ongoing use of medications known to influence glucose tolerance (e.g. sulfonylureas, metformin, diphenylhydantoin, thiazide or other potassium depleting diuretics, beta-adrenergic blockers, niacin) except insulin.
  • Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
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  • Inability to give informed consent or assent.
  • Participation in a clinical trial within the previous 6 weeks.
  • Lactating or pregnant female individual (individuals will be advised not to volunteer for the protocol if they plan to become pregnant during the time of the study and they are instructed to use an effective method of contraception).
  • Age above 25 years, since there may be several subtypes of T1DM.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

  • University of Texas, Dallas

    Dallas, Texas, 75216

  • University of Texas, Houston

    Houston, Texas, 77030

  • Children's Hospital - Kansas City

    Kansas City, Missouri

  • Children's Hospital - St. Paul

    Saint Paul, Minnesota

Other trials in United States

About this study

Official title: Ingested Interferon-Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Diabetes Mellitus

This study will see if interferon-alpha given early in the disease can stop or slow the immune attack on insulin-producing cells. In addition, the study will examine the safety and efficacy of interferon-alpha (given by mouth) to protect beta cell function. Patients between 3 and 25 years of age with Type 1 Diabetes Mellitus less then six weeks may be eligible for this study. All study-related tests and medications at the NIH Clinical Center are provided at no cost.

Read the detailed description

Type 1 diabetes mellitus (T1DM) results from autoimmune destruction of the insulin-producing pancreatic beta-cells. The onset of clinical symptoms represents the endpoint of a chronic progressive decline in beta-cell function when the number of functional beta-cells descends below the critical mass required for maintenance of euglycemia ([1], [2]). However, the pancreas still retains the ability to produce a substantial amount of insulin. The goal of secondary prevention in T1DM is to avert further destruction of the remaining beta-cells and therefore delay or stop entry into the final stages of the disease associated with end organ damage.

The rationale for this study is to interfere with the autoimmune beta-cell destruction early on in order to preserve as much residual endogenous insulin production as possible. We plan to administer oral interferon-alpha (IFN-a) on a daily basis, which has been shown to modify the clinical course of diabetes, to alter cytokine release, and reduce expression of T cell activation markers in an animal model ([3]) and a pilot project in humans (S. Brod, University of Texas, unpublished data). The one-year study is designed as a double blind randomized protocol using either 5,000 or 30,000 units of IFN-a versus placebo. Five centers will participate in this protocol (University of Texas Health Science Center in Houston; Dallas; Children's Hospital, St. Paul, MN; Kansas City and NIH, Bethesda, Maryland).

Being tested
30,000 units hrINF-alpha, 5,000 hrINF-alpha, Placebo
Keywords
Diabetes, Immunotherapy, Study Drug, Insulin Dependent Diabetes, Diabetes Mellitus, TIBM
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.

  • 30,000 units hrINF-alphaDrug

    Also called Human Recombinant Interferon-alpha

  • 5,000 hrINF-alphaDrug

    Also called Human Recombinant Interferon-alpha

  • PlaceboOther

    placebo was prepared as saline alone with 6mg human serum albumin (HSA).

Study groups in NCT00024518
Study groupRoleWhat they receive
PlaceboPlacebo comparatorplacebo was prepared as saline alone with 6mg human serum albumin (HSA). Subjects orally ingested one vial each morning before breakfast with at least 150mL water.
Receives: Other: Placebo
5,000 Units hrIFN-alphaExperimentalhrIFN-alpha = human recombinant interferon-alpha. 5,000 units was prepared along with saline and 6mg HSA. Subjects orally ingested one vial each morning before breakfast with at least 150mL water.
Receives: Drug: 5,000 hrINF-alpha
30,000 hrIFN-alphaExperimental30,000 units hrIFN-alpha was prepared along with saline and 6mg HSA. Subjects orally ingested one vial each morning before breakfast with at least 150mL water.
Receives: Drug: 30,000 units hrINF-alpha

What is being measured

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

  1. C-Peptide Level

    The Connecting Peptide, or C-peptide, is a short 31-amino-acid protein that connects insulin's A-chain to its B-chain in the proinsulin molecule.

    Measured: Baseline - 3mth, 6mnth, 9mnth, 12mnth

Secondary outcomes (2)

  1. Serum glucose

    Serum glucose or blood sugar measurements determine how much sugar is in the blood.

    Measured: baseline - 3mths, 6mnths, 9mnths, 12mnths

  2. Hemoglobin A1C

    a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

    Measured: Baseline - 3mnths, 6mnths, 9mnths, 12mnths

Timeline

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

  1. First posted19 Sep 2001 (estimated)
  2. Study startSep 2001
  3. Primary completionSep 2008
  4. Study completionSep 2008

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00024518
Sponsor's protocol ID
010249
Other IDs
01-DK-0249
Status last verified
Nov 2013
First submitted
19 Sep 2001
Last updated
19 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • Atkinson MA, Maclaren NK. The pathogenesis of insulin-dependent diabetes mellitus. N Engl J Med. 1994 Nov 24;331(21):1428-36. doi: 10.1056/NEJM199411243312107. No abstract available.

    PubMed 7969282

  • Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med. 1986 May 22;314(21):1360-8. doi: 10.1056/NEJM198605223142106. No abstract available.

    PubMed 3517648

  • Brod SA, Malone M, Darcan S, Papolla M, Nelson L. Ingested interferon alpha suppresses type I diabetes in non-obese diabetic mice. Diabetologia. 1998 Oct;41(10):1227-32. doi: 10.1007/s001250051056.

    PubMed 9794112

  • Rother KI, Brown RJ, Morales MM, Wright E, Duan Z, Campbell C, Hardin DS, Popovic J, McEvoy RC, Harlan DM, Orlander PR, Brod SA. Effect of ingested interferon-alpha on beta-cell function in children with new-onset type 1 diabetes. Diabetes Care. 2009 Jul;32(7):1250-5. doi: 10.2337/dc08-2029.

    PubMed 19564474

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 30,000 units hrINF-alpha and 5,000 hrINF-alpha in people with Insulin-Dependent Diabetes Mellitus, run by The University of Texas Health Science Center, Houston at 5 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 2 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 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. 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?

C-Peptide Level (time frame: Baseline - 3mth, 6mnth, 9mnth, 12mnth). 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 NCT00024518, which also lists 4 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 19 Nov 2013.

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