LeprosyPhase 2MetLepNCT05243654
Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy
A Phase 2 study testing Metformin in people with Leprosy and Leprosy, Multibacillary, run by Oxford University Clinical Research Unit Indonesia at 6 sites in Indonesia.
Trial 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 effects on immunological endpoints. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leprosy, Leprosy, Multibacillary, Neglected Tropical Diseases
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 6 sitesIndonesia
- Study dates
- 1 Oct 2022to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 16Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Indonesia6 sites, 5 recruiting
- Recruiting
Abe Pantai Community Health Center
Jayapura, Special Region of Papua
Nadya A Mulyadi, MD, +622123599099, nmulyadi@oucru.org
Hana Krismawati, MSc, +6282399399799, hkrismawati@gmail.com
- Withdrawn
Hamadi Community Health Center
Jayapura, Special Region of Papua
- Recruiting
Jayapura Utara Community Health Center
Jayapura, Special Region of Papua
Nandya A Mulyadi, MD, +622123599099, nmulyadi@oucru.org
Hana Krismawati, MSc, +6282399399799, hkrismawati@gmail.com
- Recruiting
Palangga Health Center
Makassar, South Sulawesi, 92161
Nandya A Mulyadi, MD, +622123599099, nmulyadi@oucru.org
Sri Vitayani, MD, PhD, +6281341821336, srivita711@gmail.com
- Recruiting
Bajeng Health Center
Makassar, South Sulawesi, 92211
Nandya A Mulyadi, MD, +622123599099, nmulyadi@oucru.org
Sri Vitayani, MD, PhD, +6281341821336, srivita711@gmail.com
- Recruiting
Sitanala Leprosy Hospital
Tangerang, Banten, 15121
Nandya A Mulyadi, MD, +622123599099, nmulyadi@oucru.org
Prima K Esti, MD, MEpid, +628128187632, prima_kartika@yahoo.com
About this study
Official title: 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 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.
Read the 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 to mitigate leprosy reactions. 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 trial aims to enroll 166 patients, aged between 18-65 years old, in leprosy endemic areas in Indonesia. Primary endpoints are the proportion of participants experiencing a leprosy reaction during the full duration of the study and the proportion of participants with at least one adverse event within the first 28 weeks of the study. Secondary endpoints are the severity and time to first leprosy reaction, the number of leprosy reactions, the cumulative corticosteroid usage, and quality of life. The total study follow-up is 48 weeks.
This METLEP trial is financially supported by the Leprosy Research Initiative (grant number: FP20\4).
- Being tested
- Metformin, Placebo
- Keywords
- Leprosy, Multibacillary leprosy, Skin-NTD
- Medical subject headings
- Leprosy, Leprosy, Multibacillary, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glumin XR
Metformin 1000mg XR OD + standard-of-care MDT
PlaceboDrug
Placebo + standard-of-care MDT
| Study group | Role | What they receive |
|---|---|---|
| Metformin 1000mg extended release (XR) once daily + standard-of-care MDT | Experimental | 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. Receives: Drug: Metformin |
| Placebo + MDT | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants experiencing a leprosy reaction
Proportion of participants experiencing a leprosy reaction during study follow-up
Measured: 48 weeks
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
Measured: 28 weeks
Secondary outcomes (15)
The proportion of participants experiencing a Type 1 Reactions (T1R)
Proportion of participants experiencing a T1R at 12, 24 and 48 weeks.
Measured: 12, 24 and 48 weeks
The proportion of participants experiencing a Type 2 Reactions (T2R)
Proportion of participants experiencing a T2 R at 12, 24 and 48 weeks.
Measured: 12, 24 and 48 weeks
The time to the first leprosy reaction
Time to first leprosy reaction over the full 48 weeks.
Measured: 48 weeks
The time to the first Type 1 Reactions (T1R)
Time to first T1R over the full 48 weeks.
Measured: 48 weeks
The time to the first Tipe 2 Reaction (T2R)
Time to first T2R over the full 48 weeks.
Measured: 48 weeks
The difference in the number of T1R episodes
The difference in the number of T1R episodes
Measured: 48 weeks
The difference in the number of T2R episodes
The difference in the number of T2R episodes
Measured: 48 weeks
The severity of T1R, based on investigator-assessed validated Clinical Severity Scores
The severity of T1R based on the Modified Type 1 Reactions Clinical Severity Scale. The score ranges from 0-48. A higher score means a worse outcome.
Measured: 48 weeks
The severity of T2R, based on investigator-assessed validated Clinical Severity Scores
The severity of T2R based on the ENLIST ENL Severity Scale. The score ranges from 0-30. A higher score means a worse outcome.
Measured: 48 weeks
The proportion of participants with at least one serious adverse event
The proportion of participants with at least one serious adverse event within the first 28 weeks of the trial.
Measured: 28 weeks
Total number of adverse events
The total number of adverse events within the first 28 weeks of the trial.
Measured: 28 weeks
The cumulative corticosteroid usage
Cumulative corticosteroid usage over the full 48 weeks.
Measured: 48 weeks
The proportion of participants experiencing clinical nerve function impairment
Proportion of participants experiencing clinical nerve function impairment developed over the full duration of the study.
Measured: 48 weeks
The difference in Quality of Life between start and end of treatment intervention, and end of study by means of SF-36 questionnaires
The difference in Quality of Life between start and end of treatment intervention, and end of study by means of the 36-Item short form survey instrument (SF-36). This is a 36-item patient-reported questionnaire that covers eight health domains. Scores for each domain are 0 to 100, with a higher score defining a more favorable health state (0 points means maximum impact on quality of life, 100 means no impact on quality of life).
Measured: 24 and 48 weeks
The difference in Quality of Life between start and end of treatment intervention, and end of study by means of the Dermatology Life Quality Index (DLQI) questionnaires.
The difference in Quality of Life between start and end of treatment intervention, and end of study by means of the Dermatology Life Quality Index (DLQI).
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0 points. A higher score defines a less favorable health state and the more quality of life is impaired.
Measured: 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Oct 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, randomized double-blind, controlled phase 2 proof-of-concept trial. Subjects will be randomised 1:1 ratio to receive metformin 1000 mg XR tablets OD or matching placebo for 24 weeks. Randomization will be stratified by BI (BI ≥ or \< 4) and participating study site.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gadjah Mada, Faculty of Medicine, University of Diponegoro, Papua Agency of Health Research and Development (NIHRD), London School of Hygiene and Tropical Medicine, Radboud University Medical Center, Oxford University Clinical Research Unit
- Responsible party
- Sponsor
- Investigators
- Hardiyanto Soebono, Prof.Dr.dr, Principal investigator, Center of Tropical Medicine, University of Gadjah Mada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243654
- Sponsor's protocol ID
- EOCRU.2021.002
- Other IDs
- OXTREC 14-21
- Acronym
- MetLep
- Status last verified
- Aug 2025
- First submitted
- 30 Sep 2021
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krismawati H, Muchtar SV, Rahardjani M, Utami NN, Oktaviani M, Puspatriani K, Syamsiah, Imbiri N, Hasvitasari DE, Fajrianti DR, Tarino N, Wulandari F, Kestelyn E, Du DH, van Crevel R, Walker SL, Geskus RB, Geluk A, Hamers RL, Soebono H, Grijsen ML. Metformin as adjunctive therapy in combination with multidrug treatment for multibacillary leprosy: A protocol for a randomized double-blind, controlled Phase 2 trial in Indonesia (MetLep Trial). Wellcome Open Res. 2024 May 9;8:289. doi: 10.12688/wellcomeopenres.19455.2. eCollection 2023.
PubMed 38808319
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05243654
- Acronym / sponsor ID
- MetLep / EOCRU.2021.002
- Keywords
- Leprosy, Multibacillary leprosy, Skin-NTD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Oxford University Clinical Research Unit IndonesiaUniversity, hospital or other
- Collaborators
- University of Gadjah Mada, Faculty of Medicine, University of Diponegoro, Papua Agency of Health Research and Development (NIHRD), London School of Hygiene and Tropical Medicine, Radboud University Medical Center, Oxford University Clinical Research Unit
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 to mitigate leprosy reactions. 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 trial aims to enroll 166 patients, aged between 18-65 years old, in leprosy endemic areas in Indonesia. Primary endpoints are the proportion of participants experiencing a leprosy reaction during the full duration of the study and the proportion of participants with at least one adverse event within the first 28 weeks of the study. Secondary endpoints are the severity and time to first leprosy reaction, the number of leprosy reactions, the cumulative corticosteroid usage, and quality of life. The total study follow-up is 48 weeks.
This METLEP trial is financially supported by the Leprosy Research Initiative (grant number: FP20\4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, randomized double-blind, controlled phase 2 proof-of-concept trial. Subjects will be randomised 1:1 ratio to receive metformin 1000 mg XR tablets OD or matching placebo for 24 weeks. Randomization will be stratified by BI (BI ≥ or < 4) and participating study site.
| Arm | Type | Receives |
|---|---|---|
| Metformin 1000mg extended release (XR) once daily + standard-of-care MDT | Experimental | Drug: MetforminMetformin 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. |
| Placebo + MDT | Placebo comparator | Drug: PlaceboMatching 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Glumin XRMetformin 1000mg XR OD + standard-of-care MDT | Drug | Metformin 1000mg extended release (XR) once daily + standard-of-care MDT |
| PlaceboPlacebo + standard-of-care MDT | Drug | Placebo + MDT |
Primary outcome
The proportion of participants experiencing a leprosy reaction
Time frame: 48 weeks
Proportion of participants experiencing a leprosy reaction during study follow-up
The proportion of participants with at least one adverse events
Time frame: 28 weeks
The proportion of participants with at least one adverse events within the first 28 weeks of the study
15 secondary outcomes
The proportion of participants experiencing a Type 1 Reactions (T1R)
Time frame: 12, 24 and 48 weeks
The proportion of participants experiencing a Type 2 Reactions (T2R)
Time frame: 12, 24 and 48 weeks
The time to the first leprosy reaction
Time frame: 48 weeks
The time to the first Type 1 Reactions (T1R)
Time frame: 48 weeks
The time to the first Tipe 2 Reaction (T2R)
Time frame: 48 weeks
The difference in the number of T1R episodes
Time frame: 48 weeks
The difference in the number of T2R episodes
Time frame: 48 weeks
The severity of T1R, based on investigator-assessed validated Clinical Severity Scores
Time frame: 48 weeks
The severity of T2R, based on investigator-assessed validated Clinical Severity Scores
Time frame: 48 weeks
The proportion of participants with at least one serious adverse event
Time frame: 28 weeks
Total number of adverse events
Time frame: 28 weeks
The cumulative corticosteroid usage
Time frame: 48 weeks
The proportion of participants experiencing clinical nerve function impairment
Time frame: 48 weeks
The difference in Quality of Life between start and end of treatment intervention, and end of study by means of SF-36 questionnaires
Time frame: 24 and 48 weeks
The difference in Quality of Life between start and end of treatment intervention, and end of study by means of the Dermatology Life Quality Index (DLQI) questionnaires.
Time frame: 24 and 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Derived from this study: PubMed 38808319Krismawati H, Muchtar SV, Rahardjani M, Utami NN, Oktaviani M, Puspatriani K, Syamsiah, Imbiri N, Hasvitasari DE, Fajrianti DR, Tarino N, Wulandari F, Kestelyn E, Du DH, van Crevel R, Walker SL, Geskus RB, Geluk A, Hamers RL, Soebono H, Grijsen ML. Metformin as adjunctive therapy in combination with multidrug treatment for multibacillary leprosy: A protocol for a randomized double-blind, controlled Phase 2 trial in Indonesia (MetLep Trial). Wellcome Open Res. 2024 May 9;8:289. doi: 10.12688/wellcomeopenres.19455.2. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hardiyanto Soebono, Prof.Dr.dr principal investigator
Center of Tropical Medicine, University of Gadjah Mada
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Leprosy and Leprosy, Multibacillary, run by Oxford University Clinical Research Unit Indonesia at 6 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlous Grijsen, MD, PhD (62-21-23599099, mgrijsen@oucru.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants experiencing a leprosy reaction (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.