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RECRUITING
NCT05243654
PHASE2

Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

Sponsor: Oxford University Clinical Research Unit Indonesia

View on ClinicalTrials.gov

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.

Official title: Efficacy and Tolerability of Adjunct Metformin in Combination With Multidrug Treatment for Multibacillary Leprosy: A Randomized Double-blind, Controlled Proof-of-Concept Phase 2 Trial in Indonesia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2022-10-01

Completion Date

2026-09-30

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

DRUG

Metformin

Metformin 1000mg XR OD + standard-of-care MDT

DRUG

Placebo

Placebo + standard-of-care MDT

Locations (6)

Sitanala Leprosy Hospital

Tangerang, Banten, Indonesia

Palangga Health Center

Makassar, South Sulawesi, Indonesia

Bajeng Health Center

Makassar, South Sulawesi, Indonesia

Abe Pantai Community Health Center

Jayapura, Special Region of Papua, Indonesia

Hamadi Community Health Center

Jayapura, Special Region of Papua, Indonesia

Jayapura Utara Community Health Center

Jayapura, Special Region of Papua, Indonesia