The Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia

May 17, 2018 updated by: Jose C. Florez, MD, PhD, Massachusetts General Hospital

A Study of the Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia in Persons With Cystic Fibrosis

The purpose of this research study is to find out if the combined therapy lumacaftor-ivacaftor affects glycemia in patient with cystic fibrosis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a single center, open label study. Patients will have 1 visits at the Diabetes Research Center (DRC), or Clinical Research Center (CRC).

The participants will have been previously screened to make sure they are candidates for the study. These patients will be contacted prior to their first visit to discuss enrollment in the study.

At the study visit the participant will come to the CRC or DRC for a research visit. The following will occur at this study visit: informed consent; brief medical history; weight and height; vital signs and blood pressure; blood draw for DNA extraction, A1c and an extra research tube for storage. This will be scheduled at a time that is convenient to the patient.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 years old or greater
  2. Patients diagnosed with cystic fibrosis (CF), genotype homozygous Phe508del
  3. 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

Exclusion Criteria

  1. Does not have a HgbA1c within 1 year prior to starting medication.
  2. Has not been on the combination therapy for at least 2 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lumacaftor-ivacaftor
Subjects will be monitored for glycemic changes before and after starting lumacaftor-ivacaftor.
Drug: lumacaftor-ivacaftor
Drug given for cystic fibrosis
Other Names:
  • Orkambi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated hemoglobin (hemoglobin A1C)
Time Frame: 1 year
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.
Time Frame: 1 year
Using chart review, the change in insulin units used per day will be calculated
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycemia contingent on genetic risk score
Time Frame: 1 year
The investigators will examine how change in glycemia is dependent on genotype at variants associated with type 2 diabetes and insulin secretion using genetic risk scores.
1 year
Pulmonary function test (PFT) forced expiratory volume at one second (FEV1) measurements
Time Frame: 1 year
The investigators will compare how PFT measurement of FEV1 are related to changes in glycemia
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (ESTIMATE)

August 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P000959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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