Actively Recruiting
Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy
Led by Oxford University Clinical Research Unit Indonesia · Updated on 2025-08-07
166
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
Sponsors
O
Oxford University Clinical Research Unit Indonesia
Lead Sponsor
U
University of Gadjah Mada, Faculty of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is male or female, aged 18 to 65 years.
- Newly diagnosed with multibacillary leprosy and has been receiving multi-drug therapy for 28 days or less.
- Willing and able to provide informed consent.
- Willing to follow the study schedule for 48 weeks.
You will not qualify if you...
- Received multi-drug therapy for more than 28 days for the current episode.
- Has leprosy reaction or nerve damage requiring systemic corticosteroids at screening.
- Previously treated for leprosy.
- Uses chronic systemic corticosteroids for other conditions (2 weeks or more).
- Has or is diagnosed with diabetes mellitus or abnormal blood glucose levels at screening.
- History of hypoglycemia.
- History of heart failure, ischemic heart disease, alcoholism, lactic acidosis, or related conditions.
- Allergic or intolerant to metformin.
- Kidney function (eGFR) below 30 mL/min/1.73m2.
- Liver enzymes (AST or ALT) three times above normal levels.
- Any serious medical condition affecting safety or study assessments.
- HIV positive at screening.
- Pregnant or breastfeeding females.
- Used metformin in the 12 weeks before the study.
- Used other regular blood sugar-lowering drugs, including insulin.
- Participated in another investigational trial within 12 weeks prior to enrollment.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Sitanala Leprosy Hospital
Tangerang, Banten, Indonesia, 15121
Actively Recruiting
2
Palangga Health Center
Makassar, South Sulawesi, Indonesia, 92161
Actively Recruiting
3
Bajeng Health Center
Makassar, South Sulawesi, Indonesia, 92211
Actively Recruiting
4
Abe Pantai Community Health Center
Jayapura, Special Region of Papua, Indonesia
Actively Recruiting
5
Hamadi Community Health Center
Jayapura, Special Region of Papua, Indonesia
Withdrawn
6
Jayapura Utara Community Health Center
Jayapura, Special Region of Papua, Indonesia
Actively Recruiting
Research Team
M
Marlous Grijsen, MD, PhD
CONTACT
M
Mutia Rahardjani, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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