Interferon-Alpha for Diabetes Mellitus Type 1
Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insulin-Dependent Diabetes Mellitus
Intervention: 30,000 units hrINF-alpha (Drug); 5,000 hrINF-alpha (Drug); Placebo (Other)
Phase: Phase 2
Status: Completed
Sponsored by: The University of Texas Health Science Center, Houston Official(s) and/or principal investigator(s): Kristina I Rother, M.D., Principal Investigator, Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Staley A Brod, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
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. 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.
Clinical Details
Official title: Ingested Interferon-Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Diabetes Mellitus
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: C-Peptide Level
Secondary outcome: Serum glucoseHemoglobin A1C
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).
Eligibility
Minimum age: 3 Years.
Maximum age: 25 Years.
Gender(s): Both.
Criteria:
- INCLUSION CRITERIA:
T1DM of less than 6 weeks duration in patients between 3 and 25 years of age.
Besides T1DM, no concurrent illness.
EXCLUSION CRITERIA:
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.
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.
Locations and Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States
Children's Hospital - St. Paul, St. Paul, Minnesota, United States
Children's Hospital - Kansas City, Kansas City, Missouri, United States
University of Texas, Dallas, Dallas, Texas 75216, United States
University of Texas, Houston, Houston, Texas 77030, United States
Additional Information
NIH Clinical Center Detailed Web Page
Related publications: Atkinson MA, Maclaren NK. The pathogenesis of insulin-dependent diabetes mellitus. N Engl J Med. 1994 Nov 24;331(21):1428-36. Review. Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med. 1986 May 22;314(21):1360-8. Review. 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.
Starting date: September 2001
Last updated: November 18, 2013
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