Study Stopped
We were unable to enroll eligible subjects for the study.
The Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia
A Study of the Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia in Persons With Cystic Fibrosis
1 other identifier
interventional
1
0 countries
N/A
Brief Summary
The purpose of this research study is to find out if the combined therapy lumacaftor-ivacaftor affects glycemia in patient with cystic fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 21, 2018
May 1, 2018
1.7 years
July 5, 2016
May 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in glycated hemoglobin (hemoglobin A1C)
A blood test will be used to determine the hemoglobin A1c change while on the medication.
1 year
Change in units of insulin used over a period of 6 months to 1 year.
Using chart review, the change in insulin units used per day will be calculated
1 year
Secondary Outcomes (2)
Change in glycemia contingent on genetic risk score
1 year
Pulmonary function test (PFT) forced expiratory volume at one second (FEV1) measurements
1 year
Study Arms (1)
Lumacaftor-ivacaftor
EXPERIMENTALSubjects will be monitored for glycemic changes before and after starting lumacaftor-ivacaftor.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 years old or greater
- Patients diagnosed with cystic fibrosis (CF), genotype homozygous Phe508del
- Subject has been started on lumacaftor-ivacaftor for clinical reasons, with no contraindication for starting the drug\* \* Contraindications for taking drug include abnormal liver enzyme tests, renal dysfunction, pregnancy or nursing mothers
You may not qualify if:
- Does not have a HgbA1c within 1 year prior to starting medication.
- Has not been on the combination therapy for at least 2 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Wainwright CE, Elborn JS, Ramsey BW, Marigowda G, Huang X, Cipolli M, Colombo C, Davies JC, De Boeck K, Flume PA, Konstan MW, McColley SA, McCoy K, McKone EF, Munck A, Ratjen F, Rowe SM, Waltz D, Boyle MP; TRAFFIC Study Group; TRANSPORT Study Group. Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR. N Engl J Med. 2015 Jul 16;373(3):220-31. doi: 10.1056/NEJMoa1409547. Epub 2015 May 17.
PMID: 25981758BACKGROUNDBellin MD, Laguna T, Leschyshyn J, Regelmann W, Dunitz J, Billings J, Moran A. Insulin secretion improves in cystic fibrosis following ivacaftor correction of CFTR: a small pilot study. Pediatr Diabetes. 2013 Sep;14(6):417-21. doi: 10.1111/pedi.12026. Epub 2013 Mar 13.
PMID: 23952705BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of the Diabetes Unit, Associate Professor Harvard Medical School
Study Record Dates
First Submitted
July 5, 2016
First Posted
August 8, 2016
Study Start
August 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
May 21, 2018
Record last verified: 2018-05