Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

Summary

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.

Timeline

Start

2022-10-01

Primary completion

2026-08-31

Completion

2026-09-30

Publications

• Krismawati H, Muchtar SV, Rahardjani M, Utami NN, Oktaviani M, Puspatriani K, Syamsiah, Imbiri N, Hasvitasari DE, Fajrianti DR, Tarino N, Wulandari F, Kestelyn E, Du DH, van Crevel R, Walker SL, Geskus RB, Geluk A, Hamers RL, Soebono H, Grijsen ML. Metformin as adjunctive therapy in combination with multidrug treatment for multibacillary leprosy: A protocol for a randomized double-blind, controlled Phase 2 trial in Indonesia (MetLep Trial). Wellcome Open Res. 2024 May 9;8:289. doi: 10.12688/wellcomeopenres.19455.2. eCollection 2023.

Drugs

Indications