Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to metformin 1000mg OD versus placebo for 24 weeks in addition to MDT during 48 weeks. The main research question is whether adjunctive metformin, combined with MDT, will improve the clinical outcomes of patients with multibacillary leprosy by mitigating leprosy reactions, thereby reducing nerve damage and corticosteroid use and its associated morbidity. The second aim is to explore whether adjunct metformin, added to MDT, has an acceptable tolerability and safety in patients with multibacillary leprosy.

This description comes directly from the study's public registry record.

Marlous Grijsen, MD, PhD  ·  62-21-23599099  ·  mgrijsen@oucru.org

Mutia Rahardjani, MD, MSc  ·  62-21-23599099  ·  mrahardjani@oucru.org

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