The Effect of Metformin on Reducing Lupus Flares

Phase 4

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: placebo; Drug: metformin

• Registration Number: NCT02741960
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-18
• Study Start: 2016-05-24
• Primary Completion: 2017-12-13
• Study Completion: 2018-12-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Willingness of the subject to participate in the study, proven by signing the informed consent;
• Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
• The course of SLE longer than1 year; and there is a clear record of disease flares in the past 1 year with prednisone more than 20mg/day;
• Patients with mild/moderate disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A or no more than one B;
• A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/ mycophenolate mofetil/ methotrexate/ ciclosporin/ leflunomide/ thalidomide) for at least 30 days.

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Exclusion Criteria

• Patients who are unwilling to sign the inform consent;
• Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits; creatinine clearance rate < 60ml/min;
• Patients who used cyclophosphamide 6-months before screening; used biological agents 12-months before screening;
• Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin;
• Patients who diagnosed of diabetes mellitus;
• Pregnancy or lactation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Eligible patients for clinical trial were randomized in a 1:1 ratio to metformin/placebo add-on. Subjects randomized to placebo will receive a target dose of 500 mg three times daily. Investigators were allowed to adjust the dose according to the patients' tolerance.
metformin	metformin	Eligible patients for clinical trial were randomized in a 1:1 ratio to metformin/placebo add-on. Subjects randomized to metformin will receive a target dose of 500 mg three times daily. Investigators were allowed to adjust the dose according to the patients' tolerance.

Primary Outcome Measures

Name	Time	Method
numbers of participants who remained at risk of flares at each visit	one year	the effect of metformin on reducing disease flares

Secondary Outcome Measures

Name	Time	Method
changes in prednisone dose from baseline at each visit	one year	the influence of metformin on corticosteroid sparing effect
changes in BMI from baseline at each visit	one year	the influence of metformin on BMI
number of participants with treatment-related adverse events	one year	the safety of metformin

Trial Locations

Locations (1)

Ethics Committee of Renji Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China