Safety and Tolerability of systemic administration of metformin in patients with Idiopathic Pulmonary Fibrosis (IPF): A randomized, placebo-controlled, double-blind, phase II proof-of-concept study (Met_for_IPF)
Idiopathic pulmonary fibrosis (IPF) is a serious condition that causes thick, stiff scars to build up in the lungs, making it harder to breathe. Researchers are testing a common medicine called metformin to find out if it is safe and can slow down this lung damage. In this phase II trial, adults with IPF will be randomly chosen to take either metformin tablets or dummy tablets (a placebo) each day. Neither the patients nor their doctors will know who gets which tablet until the trial ends. Over the course of the study, the research team will track blood markers related to scarring, check lung function, measure walking distance, and look at everyday quality of life. The main goal is to see if metformin is safe, well-tolerated, and capable of calming the scarring process in the lungs.
At a glance
What is this study about?
Idiopathic pulmonary fibrosis, often called IPF, is a long-term lung disease where lung tissue becomes thick, stiff, and scarred over time. 'Idiopathic' means doctors do not fully understand why it happens. As scar tissue builds up, the lungs struggle to move oxygen into the bloodstream. This leads to symptoms like persistent coughing, tiredness, and shortness of breath during everyday activities like walking up the stairs.
Metformin is an inexpensive, widely used medicine that has safely treated type 2 diabetes for decades. Recent laboratory research suggests that metformin may also possess anti-scarring qualities. Scientists believe it might help calm the cells in the lungs that produce excessive scar tissue, potentially slowing down the progression of IPF.
This trial is designed to test that idea in humans. Researchers will measure a specific protein in the blood called PRO-C3, which acts as a signpost for active tissue scarring. By comparing patients taking metformin to those taking a dummy pill, doctors hope to learn if metformin genuinely reduces lung scarring and whether it could become a useful new treatment option in the future.
Key takeaways
- The study tests whether the diabetes drug metformin is safe and helpful for people with idiopathic pulmonary fibrosis (IPF).
- Half of the participants will take metformin and the other half will take a dummy tablet (placebo).
- Researchers will check blood tests, walking distance, and lung capacity to see if scarring slows down.
- Participation involves regular clinic visits, breathing assessments, and answering simple health questionnaires.
- You can withdraw from the study at any point without it affecting your standard medical care.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with idiopathic pulmonary fibrosis (IPF). Both men and women can join.
Because this is an early-stage study, the doctors will need to carefully check your overall health. People with severe kidney problems, certain liver conditions, or other serious medical issues might not be able to join, as metformin can sometimes cause issues if your kidneys are not working well.
If you already take metformin for type 2 diabetes, or if you are taking certain other medications that interact with it, you may also be unable to take part. The study team will review your full medical history to confirm if it is safe for you to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF).
- I am able and willing to attend regular hospital check-ups and breathing tests.
- I do not have severe kidney disease or kidney failure.
- I am comfortable taking a daily tablet that may be either the real drug or a placebo.
What does participation involve?
If you decide to join, you will be placed into one of two groups by chance, like flipping a coin. One group will take metformin tablets by mouth every day, while the other group will take an identical-looking dummy tablet called a placebo. This is a double-blind study, meaning neither you nor the study team will know which tablet you are taking.
You will visit the clinic regularly for health check-ups. At these visits, the team will take blood samples to measure scarring markers and check your organ function. You will also take breathing tests to see how well your lungs move air and transfer oxygen into your blood.
Other checks include a 6-minute walking test to see how far you can comfortably walk, and simple questionnaires about your cough, breathing, and general quality of life. The study lasts for several months, with an extra safety check around 4 weeks after you take your last dose.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is a placebo?
A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps scientists see if changes are truly caused by the drug being tested.
Why test a diabetes medicine for a lung disease?
Early research suggests that metformin can influence the way cells heal and may stop them from laying down excess, stiff scar tissue in the lungs.
Will taking part cost me anything?
No, the study medicine and all related hospital tests are provided free of charge. Most trials also help cover travel expenses to and from the hospital.
Can I keep taking my current IPF medicines?
In many trials, standard IPF medications are allowed, but the study team will need to check your exact medicines to ensure they are safe to combine with metformin.
What happens if I feel unwell during the trial?
You will be given a direct contact number for the research team. You can reach out to them at any time, and they can adjust your dose or stop the study medicine if needed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.