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Biguanide

Metformin for Cystic Fibrosis

Phase 2
Recruiting
Led By Matthias A Salathe, M.D.
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years with a prior diagnosis of CF
Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor for 30 days prior to day 0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 14 and week 16 through week 30 of metformin treatment
Awards & highlights

Study Summary

This trial will test if metformin can help improve airway function in those with CF-related diabetes.

Who is the study for?
Adults over 18 with Cystic Fibrosis (CF) and CF-related diabetes, using specific CF medications for at least 30 days. They must show signs of glucose intolerance despite treatment. Excluded are those on certain other drugs, with recent severe illness or lung/liver transplants, pregnant or breastfeeding women, and individuals unable to follow the study's contraception guidelines.Check my eligibility
What is being tested?
The trial is testing if Metformin Hydrochloride can improve airway ion channel function in patients with CF who also have diabetes related to their condition. It aims to see if this medication can help alleviate some of the complications associated with CF.See study design
What are the potential side effects?
Metformin may cause digestive issues like stomach pain and diarrhea, a metallic taste in the mouth, vitamin B12 deficiency over long-term use, and rarely a serious condition called lactic acidosis where too much acid builds up in the blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and have been diagnosed with cystic fibrosis.
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I have been taking ivacaftor or elexacaftor/tezacaftor/ivacaftor for the last 30 days.
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I have diabetes due to cystic fibrosis and still have high blood sugar after 6 months of specific treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 14 and week 16 through week 30 of metformin treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 14 and week 16 through week 30 of metformin treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in BK channel gene expression
Secondary outcome measures
Change in BK function, as measured by nasal potential difference testing
Change in CFTR function, as measured by nasal potential difference testing
Change in Quality of Life (CFQ-R)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Metformin dose regimen BExperimental Treatment1 Intervention
Participants with CFRD on elexacaftor/tezacaftor/ivafactor who meet criteria and agree to participation in the study will be placed on metformin 500 mg twice daily on study week 0 after undergoing study procedures. If tolerated, dose will be increased by 500mg on weeks 1 and 2 to a final dose of 1000 mg twice daily through week 14.They will then undergo a two week washout period. For the second half of the study metformin will be resumed at a dose of 500 mg twice daily through the end of study (week 30).
Group II: Metformin dose regimen AExperimental Treatment1 Intervention
Participants with CFRD on elexacaftor/tezacaftor/ivacaftor who meet criteria and agree to participation in the study will be placed on metformin 500 mg twice daily on study week 0 after undergoing study procedures through week 14. They will then undergo a two week washout period. For the second half of the study metformin will be resumed and, if tolerated, dose will be increased by 500mg on weeks 17 and 18 to a final dose of 1000 mg twice daily through end of study (week 30).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin Hydrochloride
2016
Completed Phase 4
~1430

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
459 Previous Clinical Trials
169,068 Total Patients Enrolled
7 Trials studying Cystic Fibrosis
185 Patients Enrolled for Cystic Fibrosis
Matthias A Salathe, M.D.Principal InvestigatorProfessor

Media Library

Metformin Hydrochloride (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT04530383 — Phase 2
Cystic Fibrosis Research Study Groups: Metformin dose regimen B, Metformin dose regimen A
Cystic Fibrosis Clinical Trial 2023: Metformin Hydrochloride Highlights & Side Effects. Trial Name: NCT04530383 — Phase 2
Metformin Hydrochloride (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530383 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other ongoing investigations involving Metformin Hydrochloride?

"At this time, there are a total of 180 clinical trials studying the effects of Metformin Hydrochloride. Of these investigations, 45 are in Phase 3. Although many studies for Metformin Hydrochloride originate from Pittsburgh, Pennsylvania, there are 1952 locations conducting research on this medication."

Answered by AI

What type of medical conditions is Metformin Hydrochloride often used as a treatment for?

"Metformin Hydrochloride is frequently used to help people recover from strenuous exercise. However, it can also be taken as medication for type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Are there any vacancies in this trial for potential participants?

"The trial you are inquiring about is recruiting patients, as denoted on clinicaltrials.gov. The posting went up on February 14th, 2022 and was edited more recently on March 1st, of the same year."

Answered by AI

Is it dangerous to take Metformin Hydrochloride?

"Metformin Hydrochloride is in Phase 2 of clinical trials, meaning that while there is evidence supporting its safety, none exists yet for the medication's efficacy."

Answered by AI

How many people are currently enrolled in this clinical trial?

"Yes, according to the most recent update on clinicaltrials.gov, this trial is looking for 36 participants at 1 site. The trial was first posted on February 14th, 2022 and was last updated on March 1st, 2022."

Answered by AI
~12 spots leftby May 2025