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NCT02039986

Ivacaftor (Kalydeco) and Insulin in Cystic Fibrosis (CF)

Completed Last updated 14 December 2018
What this trial tests

trial in Cystic Fibrosis Related Diabetes in 13 participants. Completed in 11 October 2016.

Timeline
6 January 2014
Primary endpoint
11 October 2016
11 October 2016

Quick facts

Lead sponsorChildren's Hospital of Philadelphia
StatusCompleted
Study typeOBSERVATIONAL
Enrollment13
Start date6 January 2014
Primary completion11 October 2016
Estimated completion11 October 2016
Sites1 location across United States

Conditions studied

Sponsor

Children's Hospital of Philadelphia

Who can join

6 and older, any sex, with Cystic Fibrosis Related Diabetes or Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is aimed at better understanding the impact of ivacaftor upon insulin and incretin secretion and glucose tolerance in patients with Cystic Fibrosis with a glycine (G551D) mutation. Investigators hypothesize that treatment with ivacaftor improves insulin secretion in individuals with CF.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Glucose >200 mg/dL during Continuous Glucose Monitoring Identifies Adult Patients at Risk for Development of Cystic Fibrosis Related Diabetes.
    Taylor-Cousar JL, Janssen JS, Wilson A, Clair CG, et al · · 2016 · cited 29× · PMID 27999822 · DOI 10.1155/2016/1527932
  2. Potentiators (specific therapies for class III and IV mutations) for cystic fibrosis.
    Skilton M, Krishan A, Patel S, Sinha IP, et al · · 2019 · cited 18× · PMID 30616300 · DOI 10.1002/14651858.cd009841.pub3
  3. Cystic Fibrosis Treatment: A Paradigm for New Pediatric Medicines, Globalization of Drug Development and the Role of the European Medicines Agency.
    Rose K, Spigarelli MG. · · 2015 · cited 2× · PMID 27417354 · DOI 10.3390/children2010108

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