Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2001-09-30
2008-09-30
Brief Summary
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Detailed Description
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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of T cell activation markers in an animal model (\[3\]) and a pilot project in humans (S. Brod, University of Texas, unpublished data).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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
placebo 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.
Placebo
placebo was prepared as saline alone with 6mg human serum albumin (HSA).
5,000 Units hrIFN-alpha
hrIFN-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.
5,000 hrINF-alpha
30,000 hrIFN-alpha
30,000 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.
30,000 units hrINF-alpha
Interventions
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30,000 units hrINF-alpha
5,000 hrINF-alpha
Placebo
placebo was prepared as saline alone with 6mg human serum albumin (HSA).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Besides T1DM, no concurrent illness.
Exclusion Criteria
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.
3 Years
25 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Principal Investigators
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Kristina I Rother, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Staley A Brod, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Children's Hospital - St. Paul
Saint Paul, Minnesota, United States
Children's Hospital - Kansas City
Kansas City, Missouri, United States
University of Texas, Dallas
Dallas, Texas, United States
University of Texas, Houston
Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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01-DK-0249
Identifier Type: -
Identifier Source: secondary_id
010249
Identifier Type: -
Identifier Source: org_study_id