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Tests treatment safety and results for Leprosy
Official title Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy
ClinicalTrials.gov ID: NCT05243654
What this study is testing
What is Metformin?
Metformin is an investigational medicine, being studied as a potential treatment for leprosy.
Also referred to as Glumin XR.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to metformin 1000mg OD versus placebo for 24 weeks in addition to MDT during 48 weeks.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 48 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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...
- History of hypoglycaemia (random blood glucose \<55 mg/dL (or \<3.0 mmol/L).
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tangerang, Banten, Indonesia
- Makassar, South Sulawesi, Indonesia
- Jayapura, Special Region of Papua, Indonesia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tangerang, Banten, Indonesia; Makassar, South Sulawesi, Indonesia; Jayapura, Special Region of Papua, Indonesia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.