The Effect of Metformin on Reducing Lupus Flares

Systemic Lupus Erythematosus Clinical Trial

— Met Lupus  

Official title:

A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741960
• Other study ID #: SHDC12015902
• Status: Completed
• Phase: Phase 4
• Start date: May 24, 2016
• Est. completion date: December 7, 2018

Study information

• Verified date: September 2019
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 7, 2018
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• metformin
500 mg metformin three times daily
• placebo
500 mg placebo three times daily

Locations

Country	Name	City	State
China	Ethics Committee of Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang H, Li T, Chen S, Gu Y, Ye S. Neutrophil Extracellular Trap Mitochondrial DNA and Its Autoantibody in Systemic Lupus Erythematosus and a Proof-of-Concept Trial of Metformin. Arthritis Rheumatol. 2015 Dec;67(12):3190-200. doi: 10.1002/art.39296. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numbers of participants who remained at risk of flares at each visit	the effect of metformin on reducing disease flares	one year
Secondary	changes in prednisone dose from baseline at each visit	the influence of metformin on corticosteroid sparing effect	one year
Secondary	changes in BMI from baseline at each visit	the influence of metformin on BMI	one year
Secondary	number of participants with treatment-related adverse events	the safety of metformin	one year