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Recruiting NCT04530383

Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

Phase II Interventional Cystic Fibrosis-related Diabetes Cystic Fibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin Hydrochloride.
Who it may be relevant to
Registry conditions: Cystic Fibrosis-related Diabetes, Cystic Fibrosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open Label Clinical Trial of Metformin in Those With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

Overview

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)

Detailed description

Up to 30 patients with CFRD on highly effective CFTR modulator therapy who meet criteria and agree to participation in the study will be placed on metformin. There will be a dose-escalation starting with 500mg twice daily for a week, followed by 500mg in the AM and 1000mg in the PM for another week and finally followed by 1000mg twice daily for 14 weeks. To minimize risk of B12 deficiency, a known side effect of long-term metformin use, we will also provide a supplement of 1000 μg oral cyanocobalamin daily for the duration of the trial

Interventions

  • Drug Metformin Hydrochloride
    1000 mg twice daily

Primary outcome measures

  • Change in BK channel gene expression [Time frame: Baseline through week 14 of metformin treatment]
Secondary outcome measures (9)
  • Change in BK function, as measured by nasal potential difference testing [Time frame: Baseline through week 14 of metformin treatment]
  • Change in receptor for receptor for advanced glycation end products (RAGE) gene expression [Time frame: Baseline through week 14 of metformin treatment]
  • Change in advanced glycation end products (AGE) [Time frame: Baseline through week 14 of metformin treatment]
  • Change in sweat chloride [Time frame: Baseline through week 14 of metformin treatment]
  • Change in lung function [Time frame: Baseline through week 14 of metformin treatment]
  • Change in Quality of Life (CFQ-R) [Time frame: Baseline through week 14 of metformin treatment]
  • Change in airway inflammatory markers [Time frame: Baseline through week 14 of metformin treatment]
  • Safety of metformin [Time frame: Baseline through week 14 of metformin treatment]
  • Pharmacokinetics of metformin [Time frame: Week 14 of metformin treatment]

Eligibility criteria

Inclusion 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)

Exclusion criteria

  • 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 interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT04530383 · STUDY00146063/STUDY00161734 · R01HL157942-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗