Using metformin to improve treatment for multibacillary leprosy
Efficacy and Tolerability of Adjunct Metformin in Combination With Multidrug Treatment for Multibacillary Leprosy: A Randomized Double-blind, Controlled Proof-of-Concept Phase 2 Trial in Indonesia
This study is testing if adding metformin to the standard treatment for newly diagnosed multibacillary leprosy can help reduce complications and improve safety for patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Oxford University Clinical Research Unit Indonesia Academic / other |
| Locations | 6 sites (Tangerang, Banten and 5 other locations) |
| Trial ID | NCT05243654 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the efficacy, tolerability, and safety of adding metformin to the standard multi-drug therapy (MDT) for patients with newly diagnosed multibacillary leprosy. It is a double-blind, placebo-controlled trial where participants will be randomized to receive either metformin or a placebo for 24 weeks, alongside MDT for a total of 48 weeks. The study aims to determine if metformin can reduce leprosy reactions, nerve damage, and the need for corticosteroids, while also assessing its safety and tolerability in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have been newly diagnosed with multibacillary leprosy and have been receiving MDT for less than 28 days.
Not a fit: Patients who have received MDT for more than 28 days, have a history of leprosy treatment, or have chronic corticosteroid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with multibacillary leprosy by reducing complications and improving quality of life.
How similar studies have performed: While the use of metformin in this context is novel, other studies have explored adjunct therapies for leprosy with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Tangerang, Banten and 5 other locations
- Sitanala Leprosy Hospital — Tangerang, Banten, Indonesia (Recruiting)
- Palangga Health Center — Makassar, South Sulawesi, Indonesia (Recruiting)
- Bajeng Health Center — Makassar, South Sulawesi, Indonesia (Recruiting)
- Abe Pantai Community Health Center — Jayapura, Special Region of Papua, Indonesia (Recruiting)
- Hamadi Community Health Center — Jayapura, Special Region of Papua, Indonesia (Withdrawn)
- Jayapura Utara Community Health Center — Jayapura, Special Region of Papua, Indonesia (Recruiting)
Study contacts
- Principal investigator: Hardiyanto Soebono, Prof.Dr.dr — Center of Tropical Medicine, University of Gadjah Mada
- Study coordinator: Marlous Grijsen, MD, PhD
- Email: mgrijsen@oucru.org
- Phone: 62-21-23599099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.