Interferon-Alpha for Diabetes Mellitus Type 1

Completed · Phase 2 · Has a placebo group

Conditions studied: Insulin-Dependent Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00024518

Run by

The University of Texas Health Science Center, Houston

People needed

57

Starts

2001-09-01

Expected to finish

2008-09-01

Last updated by the study team

2013-11-19

Who can join

Age: 3 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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