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CompletedNCT02741960Met LupusUpdated Sep 17, 2019

The Effect of Metformin on Reducing Lupus Flares

A Phase 4 interventional study of metformin and placebo in Systemic Lupus Erythematosus, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-17.

Sponsored by RenJi Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • metformin
  • systemic lupus erythematosus
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In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 180 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    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.

    Drug: metformin

  • Placebo comparator
    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.

    Drug: placebo

Interventions

  • Drugmetformin

    500 mg metformin three times daily

    Also known as: Metformin Hydrochloride Tablets

  • Drugplacebo

    500 mg placebo three times daily

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What researchers measure

Primary outcomes

  1. numbers of participants who remained at risk of flares at each visit

    the effect of metformin on reducing disease flares

    Time frame: one year

Secondary outcomes

  1. changes in prednisone dose from baseline at each visit

    the influence of metformin on corticosteroid sparing effect

    Time frame: one year

  2. changes in BMI from baseline at each visit

    the influence of metformin on BMI

    Time frame: one year

  3. number of participants with treatment-related adverse events

    the safety of metformin

    Time frame: one year

07

Study locations

1 site
  • Ethics Committee of Renji Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai 200000, China
08

References and documents

Publications

  • 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. PubMed 26245802 ↗
  • Sun F, Geng S, Wang H, Wang H, Liu Z, Wang X, Li T, Wan W, Lu L, Teng X, Morel L, Ye S. Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials. Lupus Sci Med. 2020 Oct;7(1):e000429. doi: 10.1136/lupus-2020-000429. PubMed 33093216 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02741960
Lead sponsor
RenJi Hospital
Responsible party
Shuang Ye (Executive Director, Dept. Rheumatology, Renji Hospital South Campus, RenJi Hospital) — Principal investigator
First posted
Apr 18, 2016
Start date
May 24, 2016
Primary completion
Dec 13, 2017
Completion
Dec 7, 2018
Last update
Sep 17, 2019

Study contacts

Shuang Ye, MD
principal investigator · RenJi Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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