Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy
Status:
Not yet recruiting
Trial end date:
2026-02-28
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Eijkman Oxford Clinical Research Unit, Indonesia
Collaborators:
London School of Hygiene and Tropical Medicine Oxford University Clinical Research Unit Papua Agency of Health Research and Development (NIHRD) Radboud University Medical Center University of Diponegoro University of Gadjah Mada, Faculty of Medicine