Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy (MetLep)
Leprosy, Leprosy, Multibacillary, Neglected Tropical Diseases
About this trial
This is an interventional treatment trial for Leprosy focused on measuring Leprosy, Multibacillary leprosy, Skin-NTD
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.
Sites / Locations
- Abe Pantai Community Health CenterRecruiting
- Hamadi Community Health CenterRecruiting
- Jayapura Utara Community Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Metformin 1000mg extended release (XR) once daily + standard-of-care MDT
Placebo + MDT
Metformin hydrochloride 500mg XR tablets once daily by mouth for 2 weeks, escalating to a target dose of 1000mg XR once daily for another 22 weeks. Each participant will receive the same number of tablets made up of metformin and placebo to maintain the blinding.
Matching metformin placebo tablets once daily by mouth for 2 weeks, escalating to two tablets for another 22 weeks. Each participant will receive the same number of tablets made up of metformin and placebo to maintain the blinding.