What is metformin studying for multibacillary leprosy?

Metformin is being studied as an addition to standard multidrug therapy to see if it can reduce leprosy reactions and related nerve damage. Researchers want to understand if this combined treatment can improve patient outcomes and safety. The study is sponsored by Oxford University Clinical Research Unit Indonesia.

Who may be eligible for this multibacillary leprosy clinical trial?

Adults aged 18 to 65 years who are newly diagnosed with multibacillary leprosy and have started multidrug therapy within the past 28 days may be eligible. Both males and females can participate, provided they do not have certain medical conditions like diabetes or require corticosteroids for leprosy reactions. Please review eligibility criteria for more details.

Is there any cost to participate in this multibacillary leprosy clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 2

Age: 18Years - 65Years

All Genders

ID05243654

Testing Metformin Added to Standard Multidrug Treatment for Multibacillary Leprosy in Adults A Randomized, Double-Blind Phase 2 Trial in Indonesia

Led by Oxford University Clinical Research Unit Indonesia · Updated on 2025-08-07

166

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of adding metformin to standard multidrug therapy MDT for patients newly diagnosed with multibacillary leprosy. This double-blind, placebo-controlled Phase 2 trial aims to see if metformin can reduce leprosy reactions, nerve damage, and corticosteroid use while assessing immunological responses. The study is supported by the Leprosy Research Initiative and conducted in Indonesia with participants aged 18 to 65. Participants will be randomly assigned to receive either metformin or a placebo once daily. Metformin dosing starts at 500mg for two weeks, then increases to 1000mg for 22 weeks, alongside 48 weeks of standard MDT. The placebo group receives matching tablets to maintain blinding. The trial plans to enroll 166 patients to compare clinical outcomes between the two groups. During the 48-week study, participants will be regularly monitored for leprosy reactions, adverse events, nerve function, corticosteroid use, and quality of life through clinical assessments and questionnaires. The primary outcomes include the proportion of patients experiencing leprosy reactions and adverse events within specified timeframes. Secondary outcomes focus on reaction severity, timing, frequency, and impact on daily living. Safety and tolerability will also be closely observed throughout the study period.

CONDITIONS

Brief Title

Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant is a male or female, aged 6518 and 6465 years.
Participant is newly diagnosed with MB leprosy and has been receiving MDT 64 28 days.
Participant is willing and able to give informed consent for participation in the trial.
Participant is willing to adhere to study follow-up schedule for 48 weeks.

You will not qualify if you...

Participant has received MDT >28 days for the current episode of MB leprosy, prior to study enrolment.
Presence of leprosy reaction and/or nerve function impairment requiring systemic corticosteroids on screening/enrolment evaluation.
Participants who have been treated for leprosy in the past.
Chronic systemic corticosteroid use for any other medical condition on screening evaluation (chronic use defined as 651 2 weeks).
History of diabetes mellitus or diabetes mellitus diagnosed on screening evaluation (random blood glucose is elevated 65200 mg/dL (or 6511,1 mmol/L) or fasting blood glucose 65126 mg/dL (or 657.0 mmol/L)).
History of hypoglycaemia (random blood glucose <55 mg/dL (or <3.0 mmol/L)).
History of cardiac failure, ischaemic heart disease, alcoholism, history of lactic acidosis or states associated with lactic acidosis such as shock or pulmonary insufficiency, and conditions associated with hypoxia.
History of intolerance or hypersensitivity to metformin.
Estimated glomerular filtration rate (eGFR) 6430 mL/min/1.73m2 calculated by the CKDEPI equation.
AST or ALT 653 times the upper limit of normal (ULN) on screening evaluation.
Any serious medical condition for which participation in the trial, as judged by the investigator or treating physician, could compromise the well-being of the subject or prevent, limit or confound protocol-specified assessments.
HIV-positive on screening evaluation.
Female participant of childbearing age who is pregnant (clinically confirmed or urine dipstick for human chorionic gonadotrophin hormone) or breastfeeding.
Use of metformin within 12 weeks prior to study enrolment.
Use of other regular hypoglycaemic agents, including insulin.
Participation in another research trial involving an investigational product within 12 weeks prior to study enrolment.

Research Team

Marlous Grijsen, MD, PhD

Mutia Rahardjani, MD, MSc

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Testing Metformin Added to Standard Multidrug Treatment for Multibacillary Leprosy in Adults A Randomized, Double-Blind Phase 2 Trial in Indonesia

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria