Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOxford University Clinical Research Unit Indonesia
About this trial
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.
The main research question is whether adjunctive metformin, combined with MDT, will improve the clinical outcomes of patients with multibacillary leprosy by mitigating leprosy reactions, thereby reducing nerve damage and corticosteroid use and its associated morbidity. The second aim is to explore whether adjunct metformin, added to MDT, has an acceptable tolerability and safety in patients with multibacillary leprosy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin
DrugMetformin 1000mg XR OD + standard-of-care MDT
Placebo
DrugPlacebo + standard-of-care MDT
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: Metformin 1000mg extended release (XR) once daily + standard-of-care MDTExperimental treatment 1 intervention
Group B: Placebo + MDTPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of participants experiencing a leprosy reaction
Proportion of participants experiencing a leprosy reaction during study follow-up
Time frame
48 weeks2
The proportion of participants with at least one adverse events
The proportion of participants with at least one adverse events within the first 28 weeks of the study
Time frame
28 weeksSecondary outcomes
1
The proportion of participants experiencing a Type 1 Reactions (T1R)
Proportion of participants experiencing a T1R at 12, 24 and 48 weeks.
Time frame
12, 24 and 48 weeks2
The proportion of participants experiencing a Type 2 Reactions (T2R)
Proportion of participants experiencing a T2 R at 12, 24 and 48 weeks.
Time frame
12, 24 and 48 weeks3
The time to the first leprosy reaction
Time to first leprosy reaction over the full 48 weeks.
Time frame
48 weeks4
The time to the first Type 1 Reactions (T1R)
Time to first T1R over the full 48 weeks.
Time frame
48 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oxford University Clinical Research Unit Indonesia
Lead sponsor
University of Gadjah Mada, Faculty of Medicine
Collaborator
University of Diponegoro
Collaborator
Papua Agency of Health Research and Development (NIHRD)
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator
Radboud University Medical Center
Collaborator
Oxford University Clinical Research Unit
Collaborator
Source ClinicalTrials.gov