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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

Must not have

Use of supplemental oxygen

CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 14 and week 16 through week 30 of metformin treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use supplemental oxygen.

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I was hospitalized or needed IV antibiotics for a lung flare-up in the last 30 days.

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I am taking medication that interacts with metformin.

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I have had a lung or liver transplant.

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I am not taking any strong medication that affects liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 14 and week 16 through week 30 of metformin treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in BK channel gene expression

Secondary study objectives

Change in BK function, as measured by nasal potential difference testing

Change in Quality of Life (CFQ-R)

Change in advanced glycation end products (AGE)

+6 more

Side effects data

From 2023 Phase 2 trial • 40 Patients • NCT03733132

35%

Diarrhea

10%

Anemia

10%

Nausea

10%

Gastroesophageal reflux disease

Hepatobiliary disorders

Weight loss

Fall

COVID-19 Infection

Flatulence

Pain

Social circumstances

Vomiting

Headache

Stroke

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Metformin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1990

0 / 7Eligibility criteria met