Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

Launched by EIJKMAN OXFORD CLINICAL RESEARCH UNIT, INDONESIA · Feb 7, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding a medication called metformin to the standard treatment for multibacillary leprosy can help improve patient outcomes. The standard treatment, known as multi-drug therapy (MDT), is already effective, but researchers want to see if metformin can reduce leprosy-related complications, like nerve damage and the need for corticosteroids, which can have side effects. The trial will involve newly diagnosed patients who will be randomly assigned to receive either metformin or a placebo (a sugar pill with no active medication) for 24 weeks, alongside their regular MDT for 48 weeks.

To participate in this trial, individuals must be between 18 and 65 years old and newly diagnosed with multibacillary leprosy, having started MDT less than 28 days prior. Participants should be willing to follow the study's schedule and provide informed consent. However, those with certain medical conditions, including a history of diabetes or severe kidney problems, as well as those who have received prolonged treatment for leprosy before, will not be eligible. If you join the study, you will be monitored closely for safety and tolerability, and you can help researchers learn more about the potential benefits of metformin for people with leprosy.

Gender

ALL

Eligibility criteria

• 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 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.