At a glance
ClinicalIndex Comparison Record- ✓Aged 18-65 years
- ✓Newly diagnosed with MB leprosy and receiving MDT ≤28 days
- ✓Willing and able to give informed consent
- ✓Willing to adhere to 48-week follow-up schedule
- ✕Prior MDT >28 days for current MB leprosy episode
- ✕Leprosy reaction and/or nerve function impairment requiring systemic corticosteroids
- ✕Prior leprosy treatment history
- ✕Chronic systemic corticosteroid use (≥2 weeks) for other medical conditions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Metformin and Placebo for Leprosy and 2 related conditions. Currently recruiting, targeting 166 participants across 6 sites.
Signals
Detailed 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. 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.
Study Details
Timeline
Interventions
Metformin 1000mg XR OD + standard-of-care MDT
Placebo + standard-of-care MDT