The New England journal of medicine
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus.
Type 1 diabetes mellitus is a chronic autoimmune disease caused by the pathogenic action of T lymphocytes on insulin-producing beta cells. Previous clinical studies have shown that continuous immune suppression temporarily slows the loss of insulin production. Preclinical studies suggested that a monoclonal antibody against CD3 could reverse hyperglycemia at presentation and induce tolerance to recurrent disease. ⋯ Treatment with hOKT3gamma1(Ala-Ala) mitigates the deterioration in insulin production and improves metabolic control during the first year of type 1 diabetes mellitus in the majority of patients. The mechanism of action of the anti-CD3 monoclonal antibody may involve direct effects on pathogenic T cells, the induction of populations of regulatory cells, or both.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Effects of insulin in relatives of patients with type 1 diabetes mellitus.
It is unknown whether insulin therapy can delay or prevent diabetes in nondiabetic relatives of patients with diabetes. ⋯ In persons at high risk for diabetes, insulin at the dosage used in this study does not delay or prevent type 1 diabetes.