Interferon-Alpha for Diabetes Mellitus Type 1
Insulin-Dependent Diabetes Mellitus
About this trial
This is an interventional treatment trial for Insulin-Dependent Diabetes Mellitus focused on measuring Diabetes, Immunotherapy, Study Drug, Insulin Dependent Diabetes, Diabetes Mellitus, TIBM
Eligibility 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.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
- Children's Hospital - St. Paul
- Children's Hospital - Kansas City
- University of Texas, Dallas
- University of Texas, Houston
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo
5,000 Units hrIFN-alpha
30,000 hrIFN-alpha
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.
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.
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.