At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 180 enrolled
Drug / intervention
metformin +1 moredrug
Likely dose
metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus
In Brief
A Phase 4 clinical trial evaluating metformin and placebo for Systemic Lupus Erythematosus. Completed, enrolled 180 participants across 1 site.
Detailed Summary
This is a multicenter, randomised, double-blind placebo controlled trial on the efficacy and safety of add-on metformin to conventional immunosuppressants in systemic lupus erythematosus (SLE). The purpose of this study is to evaluate: 1) the effect of metformin on reducing disease flares; 2) the influence of metformin on corticosteroid sparing effect; 3) the influence of metformin on body mass index (BMI); 4) the safety of metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartMay 2016
Primary CompletionDec 2017
Study CompletionDec 2018
TodayJul 2026
First PostedApr 18, 2016
Enrollment StartMay 24, 2016
Primary CompletionDec 13, 2017
Study CompletionDec 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.2 years ago
Interventions
metformindrug
500 mg metformin three times daily
placebodrug
500 mg placebo three times daily