OCTREOTIDE PLUS TAMOXIFEN IN BREAST CANCER

$0M01FY2000RRNIH

Tulane University Of Louisiana, New Orleans LA

Investigators

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Abstract

This trial is part of a multi-center protocol to determine whether daily orally administered insulin can preserve endogenous insulin secretion after onset of immune mediated (type 1) diabetes (IMD). Eligible patients will be between 5-60 years of age, will not have diabetes for more than two years, nor be treated with insulin replacement therapy for more than six weeks. Three hundred patients will be recruited, with half below age 20 and half above. Patients will be randomized into three treatment groups, (ie. 1 mg and 10 mgs of oral recombinant human insulin, and a placebo arm). Plasma C-peptide responses to a mixed meal tolerance will be done six times monthly for up to three years. Immunological studies are planned to examine the mechanism responsible if a positive metabolic effect is found.

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