Full project title:
Efficacy and Tolerability of Adjunct Metformin in Combination with Standard Multidrug Treatment for Multibacillary Leprosy: A Randomized Double-blind, Controlled Proof-of-Concept Trial in Indonesia
Project coordination
Oxford University
Partners
Gadjah Mada University
University of Diponegoro
Aim: This study aims to investigate a new treatment strategy to limit or prevent the development of leprosy reactions and its consequences.
Project summary
Presently, the standard treatment of leprosy is with a combination of three antibiotics, also referred to as multidrug therapy (MDT), often given for one year. One of the main challenges of MDT is the occurrence of so-called leprosy reactions, which is a strong inflammatory response of the body’s immune system to the leprosy infection. This can happen in about 30 to 50% of all patients and can cause nerve injuries leading to disabilities and deformities. Leprosy reactions are very difficult to treat as they are often chronic and recurrent. This means that many people who have a leprosy reaction need to use medicines that suppress the inflammation, called corticosteroids, for long periods of time. However, corticosteroids have many serious side-effects, such as diabetes, osteoporosis, psychological and eye problems, and susceptibility to (severe) infections.
Therefore, this study aims to investigate a new treatment strategy to limit or prevent the development of leprosy reactions and its consequences. The researchers want to find out whether a medicine called metformin, if given in combination with standard MDT, can kill the leprosy bacteria faster, prevent or limit leprosy reactions, and thus reduce the need for corticosteroids. Metformin is a cheap and safe drug that has been used for over decades in the treatment of people with diabetes, and is now receiving renewed interest as a promising drug that can have a positive effect on how the body’s immune system reacts to infections.
A team of researchers from Indonesia and abroad proposes to conduct a clinical trial involving 110 people who have been newly diagnosed with multibacillary leprosy in Indonesia. The study participants will be randomly divided into two groups: one will receive metformin and the other will receive a placebo (an inert drug) for a period of half a year. Both groups will, at the same time, start with the standard MDT, given for a full year.
Through this clinical trial, researchers hope to find out whether the use of metformin is safe and well-tolerated by the volunteers. They also hope to see that metformin could protect against the occurrence of leprosy reactions. Hopefully, the information provided by the research will help to improve the treatment of patients with leprosy in the future, by preventing disabilities and deformations, both in Indonesia and worldwide.
Impact
Picturing health: the burden of leprosy in eastern Indonesia Pieter Y, Grijsen ML. The Lancet. Elsevier BV. 2022; 399 (10335) : 1588-1599.
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) https://wellcomeopenresearch.org/articles/8-289/v1