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medRxiv PreprintsInternational13 October 2026

Immune Training with BCG therapy in Diabetes: Outcomes of a Phase 2 randomized clinical trial

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BCG is a well recognized old generic drug that can mold the human immune system through Immune Training. Broad basic science studies support Immune Training, but formal randomized placebo control trials are frequently lacking for confirmation of human benefits. Here we report on a randomized, double-blind, placebo-controlled phase 2 trial with up to 8 years of follow-up. The primary outcome was mean percent change from baseline in HbA1c. At year 5, HbA1c in the BCG group was reduced from baseline by 7.04% (P=0.0006) and at year 8 by 12.84% (P=0.0001), whereas HbA1c did not change from baseline
— medRxiv Preprints
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