Using metformin to improve treatment for multibacillary leprosy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the efficacy, tolerability, and safety of adding metformin to the standard multi-drug therapy (MDT) for patients with newly diagnosed multibacillary leprosy. It is a double-blind, placebo-controlled trial where participants will be randomized to receive either metformin or a placebo for 24 weeks, alongside MDT for a total of 48 weeks. The study aims to determine if metformin can reduce leprosy reactions, nerve damage, and the need for corticosteroids, while also assessing its safety and tolerability in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant is a male or female, aged ≥18 and ≤65 years.
* Participant is newly diagnosed with MB leprosy and has been receiving MDT ≤ 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.

Exclusion Criteria:

* 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 ≥ 2 weeks).
* History of diabetes mellitus or diabetes mellitus diagnosed on screening evaluation (random blood glucose is elevated ≥200 mg/dL (or ≥11,1 mmol/L) or fasting blood glucose ≥ 126 mg/dL (or ≥7.0 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) ≤30 mL/min/1.73m2 calculated by the CKDEPI equation.
* AST or ALT ≥3 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.

Where it's running

• Sitanala Leprosy Hospital
  Tangerang, Banten, Indonesia Recruiting
• Palangga Health Center
  Makassar, South Sulawesi, Indonesia Recruiting
• Bajeng Health Center
  Makassar, South Sulawesi, Indonesia Recruiting
• Abe Pantai Community Health Center
  Jayapura, Special Region of Papua, Indonesia Recruiting
• Jayapura Utara Community Health Center
  Jayapura, Special Region of Papua, Indonesia Recruiting
• Hamadi Community Health Center
  Jayapura, Special Region of Papua, Indonesia Withdrawn

Study contacts

• Principal investigator: Hardiyanto Soebono, Prof.Dr.dr — Center of Tropical Medicine, University of Gadjah Mada
• Study coordinator: Marlous Grijsen, MD, PhD
• Email: mgrijsen@oucru.org
• Phone: 62-21-23599099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.