Background

Leprosy continues to be a public health problem, with worldwide more than 200.000 new cases recorded annually, predominantly affecting underprivileged and marginalized populations. Indonesia has the third highest number of leprosy cases in the world with 17.439 newly diagnosed cases in 2019.

The clinical management of leprosy is complicated by immune-mediated reactions, which are the most important cause of irreversible nerve damage leading to disabilities and deformities, imposing a social and financial burden on patients and their households. Reactions are difficult to treat as they are often chronic, recurrent and require long-term use of corticosteroids that have serious side effects (i.e. diabetes, osteoporosis, opportunistic infections).

There is a great need to improve treatment strategies and design effective, safe and affordable interventions, which prevent the development of leprosy reactions and subsequent neurological impairments.

Aims

We will also evaluate the tolerability and safety of adjunctive metformin in patients with multibacillary leprosy. MetLep is a double-blind randomized controlled trial meaning participants are randomly assigned metformin or placebo without the participant nor the healthcare workers knowing whether they receive the active drug or placebo.

Output

Participant recruitment is currently ongoing. Final results are expected in 2026.