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Drug & research development » Clinical trials » NCT02039986

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

Official title: Effects of Ivacaftor (Kalydeco) Treatment Upon Insulin and Incretin Secretion in Patients With Cystic Fibrosis

Clinical Trials gov number: NCT02039986

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Purpose: To better understand the impact of ivacaftor on insulin and incretin secretion and glucose tolerance in patients with CF with a glycine (G551D) mutation. Investigators hypothesise that treatment with ivacaftor improves insulin secretion in CF patients.

Phase: NA

Type: Observational, prospective

Study Sponsor: Children’s Hospital of Philadelphia

  • At least one G551D CFTR mutation or other non-G551D gating mutation, or residual function CFTR mutation such as, but not limited to, R117H mutation, for which ivacaftor is to be initiated
  • Plan to initiate ivacaftor treatment for FDA approved indications by clinical care team or as part of an ongoing study of ivacaftor for other CFTR mutations, including gating mutations, or residual function mutations
  • Not pregnant

Intervention
Ivacaftor

Geographical Location
United States

Number of Participants
≤50 (≥6 years)

Primary Endpoint

Change from baseline in insulin secretion capacity at 16 weeks

Secondary Endpoint

Composite change from baseline in relationships of insulin secretion and protein and interleukin levels at 16 weeks

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All subjects enrolled in same cohort

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