Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

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 thetrial.
• 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 tostudy enrolment.
• Presence of leprosy reaction and/or nerve function impairment requiring systemiccorticosteroids on screening/enrolment evaluation.
• Participants who have been treated for leprosy in the past.
• Chronic systemic corticosteroid use for any other medical condition on screeningevaluation (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 bloodglucose ≥ 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 lacticacidosis or states associated with lactic acidosis such as shock or pulmonaryinsufficiency, 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 CKDEPIequation.
• 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 theinvestigator or treating physician, could compromise the well-being of the subject orprevent, limit or confound protocol-specified assessments.
• HIV-positive on screening evaluation.
• Female participant who is pregnant (clinically confirmed or urine dipstick for humanchorionic 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 12weeks prior to study enrolment.