Status:
RECRUITING
Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy
Lead Sponsor:
Oxford University Clinical Research Unit Indonesia
Collaborating Sponsors:
University of Gadjah Mada, Faculty of Medicine
University of Diponegoro
Conditions:
Leprosy
Leprosy, Multibacillary
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effec...
Detailed Description
A double-blind, placebo-controlled randomized proof-of-concept Phase 2 trial will be performed evaluating the efficacy, safety and tolerability of adjunct metformin combined with standard of care MDT ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT05243654
Start Date
October 1 2022
End Date
September 30 2026
Last Update
August 7 2025
Active Locations (6)
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1
Sitanala Leprosy Hospital
Tangerang, Banten, Indonesia, 15121
2
Palangga Health Center
Makassar, South Sulawesi, Indonesia, 92161
3
Bajeng Health Center
Makassar, South Sulawesi, Indonesia, 92211
4
Abe Pantai Community Health Center
Jayapura, Special Region of Papua, Indonesia