Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis

NCT05910554 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: HP-00105681
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sarcoidosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

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

  Mean daily oral corticosteroid dose post protocol-driven steroid taper at 24-weeks after randomization.

  24 weeks

Secondary Outcomes (1)

• To compare cumulative total steroid use between those randomized to metformin or placebo

  24 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

Patients randomized to metformin will be assigned the active arm.

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Patients randomized to cellulose will be assigned the placebo arm.

Drug: Cellulose

Interventions

Metformin DRUG

Patients randomized to metformin will be assigned the active arm.

Also known as: glyburide

Active

Cellulose DRUG

Patients randomized to cellulose will be assigned the placebo arm.

Also known as: cellulose powder

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Allergy or intolerance to metformin
• Allergy or intolerance to albuterol
• Poor venous access for obtaining blood samples
• Significant disorder, other than sarcoidosis, that would complicate the treatment evaluation, such as respiratory, cardiac, renal, neurologic, musculoskeletal or seizure disorders.
• 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.
• ALT or AST ≥5 times upper limit of normal (ULN).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Interventions

Metformin; Glyburide; Cellulose

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sulfonylurea Compounds; Urea; Amides; Sulfones; Sulfur Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Metformin capsules will be encapsulated by the Investigational Drug Services to blind study participants and providers, as well study personnel.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 18, 2023
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share