At a glance
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Metformin as Adjunctive Therapy in Overweight and Obese Patients With Dengue: an Open-label Safety and Tolerability Trial
In Brief
A Phase 2 clinical trial evaluating Metformin for Dengue and 5 related conditions. Completed, enrolled 120 participants across 1 site.
Detailed Summary
This study aims to investigate the effect of metformin as host-directed therapy in obese/overweight patients with dengue Primary Objective To evaluate the safety and tolerability of metformin in obese/overweight young adults and children with dengue Secondary Objectives * To assess the effect of metformin therapy in obese/overweight patients with dengue on physiological, clinical and virological parameters * To assess the immunomodulation effects of metformin therapy in obese/overweight patients with dengue * To assess difference in gene expression between treatment group compared to non-treatment population
Study Details
Timeline
Interventions
The trial will be conducted in two phases, with a dose escalation of metformin. Metformin dosing will begin at 500mg (children) and 850mg (adults) once daily for 5 days in cohort 1. Cohort 2 will be received weight-based doses; 5 days of 1000mg (500mg twice daily) for those weighing \<60kg and 5 days of 1500mg (1000mg mane, 500mg nocte) for those weighing ≥60kg