Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

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.