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Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. Patients must be symptomatic of pulmonary sarcoidosis with FVC 45-85% 3. Steroid dosage of >10mg of prednisone for at least 6 months.

Exclusion Criteria:

1. Inability to obtain consent. 2. Age less than 18 years of age. 3. 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. 4. FVC predicted value is < 45%. 5. Creatine clearance of <30%. 6. History of idiopathic Lactate ≥ 2.2 mmol/L or acidosis on study baseline metabolic profile. 7. End-stage fibrotic pulmonary disease. 8. Significant underlying liver disease. 9. Allergy or intolerance to metformin. 10. Allergy or intolerance to albuterol. 11. Poor venous access for obtaining blood samples. 12. Significant disorder, other than sarcoidosis, that would complicate the treatment evaluation, such as respiratory, cardiac, renal, neurologic, musculoskeletal or seizure disorders. 13. Use of an investigational drug within 30 days prior to screening or within 5 half-lives of the agent, whichever is longer. 14. Currently receiving >40mg prednisone. 15. ALT or AST ≥5 times upper limit of normal (ULN). 16. Leukopenia, as defined by WBC <3.0 cells/mm3 or absolute neutrophil count <1000 mm3. 17. Breast feeding. 18. If patient is on immunomodulators, they must be on regimen for ≥3-month period and on a stable dose for ≥ 4 weeks. 19. Most recent nuclear medicine scan or echocardiogram (if done), demonstrating cardiac ejection fraction <35% 20. 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. 21. 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. 22. On medications that, in the opinion of the investigator, would affect patient safety when taken with metformin. 23. History of or receiving treatment for pulmonary hypertension. Receiving biologic medication within the 6 months prior to screening visit.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05910554
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Maryland, Baltimore
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sarcoidosis, Pulmonary

Additional Details

The purpose of this study is to assess the efficacy of Metformin therapy in terms of steroid-sparing efficacy for sarcoidosis patients with steroid-dependent disease. Given that the morbidity and mortality has proven to be significant in patients with sarcoidosis, we believe there is unprecedented opportunity for improved clinical outcomes if the right interventional agent can be identified. In choosing steroid-sparing effect as the primary outcome, we will be able to detect changes in clinical outcomes that are important to patients and to the scientific community. We anticipate that these improvements will reduce or resolve the necessity of immunosuppressant therapy in these participants. At least 40 participants will be randomized in equal proportion to metformin or placebo. Twenty completed participants per arm provide 80% power to reject (one-sided type I error of 5%) the null hypothesis that mean daily steroid use in the placebo treated group is less than in the metformin treated group using analysis of covariance adjusting for baseline average steroid use.

Arms & Interventions

Arms

Active Comparator: Active

Patients randomized to metformin will be assigned the active arm.

Placebo Comparator: Placebo

Patients randomized to cellulose will be assigned the placebo arm.

Interventions

Drug: - Metformin