WithdrawnPhase 2

Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis

Stopped: Many of sarcoidosis patients in this area already taking metformin

0Started 2025-12-10

Plain-language summary

This is a double blinded, randomized, placebo controlled clinical trial of 40 participants with pulmonary sarcoidosis. Primary Objective: To assess the steroid-sparing efficacy and safety of oral metformin therapy in participants with confirmed progressive pulmonary sarcoidosis for participants with steroid dependent disease.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as defined by the clinical presentation consistent with sarcoidosis, as well as biopsy demonstrating granulomas, and no alternative for the cause of the granulomas, such as tuberculosis for at least one year prior to randomization. Tuberculosis must be ruled out by negative histology and culture.
✓. Patients must be symptomatic of pulmonary sarcoidosis with FVC 45-85%
✓. Steroid dosage of \>10mg of prednisone for at least 6 months

Exclusion criteria

✕. Inability to obtain consent
✕. Age less than 18 years of age
✕. Female participants of childbearing potential not willing use one of the following methods of birth control for the duration of the study and 90 days after study completion: condoms, sponge, foams, jellies, diaphragm, or non-hormonal intrauterine device, a vasectomized sole partner or abstinence. Females of childbearing potential must have a negative urine pregnancy test at screening visit
✕. FVC predicted value is \< 45%.
✕. Creatine clearance of \<30%.
✕. History of idiopathic Lactate ≥ 2.2 mmol/L or acidosis on study baseline metabolic profile
✕. End-stage fibrotic pulmonary disease
✕. Significant underlying liver disease

What they're measuring

To assess the steroid-sparing efficacy and safety of oral metformin therapy in patients with progressive pulmonary sarcoidosis.

Timeframe: 24 weeks

Trial details

NCT IDNCT05910554

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

View on ClinicalTrials.gov More Sarcoidosis, Pulmonary trials