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Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy
Sponsor: Oxford University Clinical Research Unit Indonesia
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
Metformin
Metformin 1000mg XR OD + standard-of-care MDT
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