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New treatment option for Cystic Fibrosis-related Diabetes
Official title Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function
ClinicalTrials.gov ID: NCT04530383
What this study is testing
What is Metformin Hydrochloride?
Metformin Hydrochloride is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cystic fibrosis-related diabetes.
Also referred to as Glucophage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with CF-related diabetes (CFRD)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>18 years with a prior diagnosis of CF.
- Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor or vanzacaftor/tezacaftor/deutivacaftor for 30 days prior to day 0
- Diagnosis of CFRD with evidence of continued glucose intolerance at least 6 months after starting qualifying modulator therapy will be based upon one...
- Insulin use
- Hemoglobin A1C \>6.5%
You likely can't join if
- Prior lung or liver transplant
- Use of supplemental oxygen
- BMI \<18
- CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
- Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
- Cardiac, renal (creatinine clearance \<45 mL/minute), neurologic, psychiatric, endocrine or neoplastic diseases that are judged to interfere with...
See the full eligibility criteria
- Age \>18 years with a prior diagnosis of CF.
- Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor or vanzacaftor/tezacaftor/deutivacaftor for 30 days prior to day 0
- Diagnosis of CFRD with evidence of continued glucose intolerance at least 6 months after starting qualifying modulator therapy will be based upon one of the following:
- Insulin use
- Hemoglobin A1C \>6.5%
- Fasting glucose \>126 mg/dl
- Non-fasting glucose \>200 mg/dl (random or as part of a 2-hr OGTT)
- Prior lung or liver transplant
- Use of supplemental oxygen
- BMI \<18
- CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
- Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
- Cardiac, renal (creatinine clearance \<45 mL/minute), neurologic, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in the study
- Alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase \>1.5X the upper limit of normal; bilirubin \>3 mg/dL
- Taking medications that interact with metformin.
- Vitamin B12 deficiency
- Pregnancy or lactation
- Inability or unwillingness to comply with an approved contraceptive method during the study period (females of childbearing age)
- Use of medications known to be strong CYP inducers or moderate to strong CYP inhibitors
- In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the subject inappropriate for enrollment
- Participation in another treatment trial that, in the opinion of the investigator, has the potential to affect the primary outcome
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Kansas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Kansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.