Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis

Trial details

Who runs it

University of Maryland, Baltimore

Trial code

NCT05910554

Record updated

11 February 2025

Original description

This is a double blinded, randomized, placebo controlled clinical trial of 40 participants with pulmonary sarcoidosis.Read full original descriptionShow less

Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial

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.

Inclusion: 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: Use of an investigational drug within 30 days prior to screening or within 5 half-lives of the agent, whichever is longer; Currently receiving >40mg prednisone; Participant has persistent or active infections requiring hospitalization or treatment with antibiotics, antiretrovirals, or antifungals within 30 days of baseline. Minocycline and doxycycline are not considered antibiotics when used to treat sarcoidosis; Any significant finding in the patient's medical history or physical or psychiatric exam prior to or after randomization that, in the opinion of the investigator, would affect patient safety or compliance or ability to deliver the study drug according to protocol; On medications that, in the opinion of the investigator, would affect patient safety when taken with metformin; History of or receiving treatment for pulmonary hypertension. Receiving biologic medication within the 6 months prior to screening visit; End-stage fibrotic pulmonary disease; Significant underlying liver disease; Allergy or intolerance to metformin; Allergy or intolerance to albuterol; Significant disorder, other than sarcoidosis, that would complicate the treatment evaluation, such as respiratory, cardiac, renal, neurologic, musculoskeletal or seizure disorders; Creatine clearance of <30%; History of idiopathic Lactate ≥ 2.2 mmol/L or acidosis on study baseline metabolic profile; ALT or AST ≥5 times upper limit of normal (ULN); Leukopenia, as defined by WBC <3.0 cells/mm3 or absolute neutrophil count <1000 mm3; Most recent nuclear medicine scan or echocardiogram (if done), demonstrating cardiac ejection fraction <35%; Age less than 18 years of age; Inability to obtain consent; 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%; Poor venous access for obtaining blood samples; Breast feeding; If patient is on immunomodulators, they must be on regimen for ≥3-month period and on a stable dose for ≥ 4 weeks.

ClinicalTrials.gov NCT05910554