Type 1 Diabetes

The Immunobiology Lab at MGH is currently conducting multiple clinical trials using Bacillus Calmette-Guérin (BCG), an inexpensive generic drug, as a treatment for advanced type 1 diabetes. The BCG clinical trial program has been underway for almost 10 years. To date, more than 120 patients with longstanding type 1 diabetes have been treated with at least two doses of BCG. In June 2018, we published data showing that BCG-treated patients followed for more than five years had a statistically significant change in HbA1c, no major complications nor severe hypoglycemic events compared to placebo. A 150-patient, randomized, placebo-controlled, Phase II clinical trial is currently fully enrolled and all patients have been followed for at least one year. Other clinical studies include those related to ongoing on biomarker development, BCG strain comparison, drug stability with different BCG formulation formats, systemic glucose utilization with radiography and, soon, expanded studies into additional autoimmune diseases. Pending funding and FDA approval, MGH is planning several additional human clinical trials, including pediatric trials and trials in a broader selection of patients with longstanding type 1 diabetes.