Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor (GLUCORRECTOR)
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ClinicalTrials.gov Identifier: NCT03512119 |
Recruitment Status :
Completed
First Posted : April 30, 2018
Last Update Posted : November 24, 2021
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Cystic Fibrosis related diabetes (CFRD), a major factor of morbid-mortality in CF, is characterized by a preclinical phase of glucose intolerance particularly long reaching up to 10 years.
At the physiopathology level, insulin secretion is determinant in the glucose tolerance abnormalities in CF. Indeed insulin secretion is dependent of the CFTR activity at the beta cell surface and inhibition of CFTR leads to a decrease in insulin secretion.
Recently, the combination of the lumacaftor, a CFTR corrector, with Ivacaftor, a CFTR potentiator, was studied in patient with CF homozygous for the Phe508 del CFTR mutation patients and showed an improvement of the respiratory state in comparison with the placebo group.
These data suggests that lumacaftor in combination with ivacaftor in targeting CFTR action may have an early impact on the insulin-secretion and consequently on the glucose tolerance.
Condition or disease | Intervention/treatment |
---|---|
Cystic Fibrosis Homozygous for Phe 508 Del CFTR Glucose Intolerance or Newly Diagnosis Diabetes | Drug: Lumacaftor-Ivacaftor treatment |
Study Type : | Observational |
Actual Enrollment : | 55 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
Official Title: | Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor |
Actual Study Start Date : | February 11, 2016 |
Actual Primary Completion Date : | April 10, 2019 |
Actual Study Completion Date : | April 10, 2019 |

Group/Cohort | Intervention/treatment |
---|---|
Patient
Patient with cystic fibrosis homozygous for Phe 508 del CFTR having a glucose intolerance or newly diagnosis diabetes
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Drug: Lumacaftor-Ivacaftor treatment
Lumacaftor-Ivacaftor treatment during one year |
- Measure of 2 hours plasma glucose value (mmol/l) of OGTT, change from baseline at one year of Lumacaftor-Ivacaftor treatment [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- Fasting and one hour glucose value of OGTT (mmol/l) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- C peptide and insulin values at T0, 1 , 2 hours of OGTT (µg/l) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- Glucose, insulin and C peptide AUC of OGTT (µU/L) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- HOMA -R , HOMA-S [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- Mean glucose value per day and 2 h after meal (mg/dl) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- Duration in hypoglycemic area [hypo CGM = 2 consecutive values below 3.3 mmol/l - % of time spent] [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- Duration in hyperglycemic area [for glucose value higher than 7.7 mmol/l, % time /24h] [ Time Frame: Day 0 (traitement beginning) and year 1 ]Number hypoglycaemic events (below 3.3mmol/L, from midnight to 6 am) Variability glycemic indexes: MAGE (mg/dl), SD (mg/dl)
- Number hypoglycaemic events (below 3.3mmol/L, from midnight to 6 am) [ Time Frame: Day 0 (traitement beginning) and year 1 ]Variability glycemic indexes: MAGE (mg/dl), SD (mg/dl)
- Variability glycemic indexes: MAGE (mg/dl), SD (mg/dl) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- HbA1c (mmol/l and %) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- Daily insulin doses (UI/day) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- (BMI) body mass index [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- Weight (Kg) maximum weight never reached [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- Albumin and Pre albumin (g/l) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- FEV1, Vital Capacity (VC) (L and %) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- O2 saturation (%) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
- Number of cures of antibiotics IV and per os /year and interval between 2 cures (week) [ Time Frame: Day 0 (traitement beginning) and year 1 ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- patients with CF homozygous for the Phe508del CFTR mutation aged 12 years and over
- Combined Lumacaftor-Ivacaftor treatment scheduled or already started
- glucose intolerance in OGTT (ADA criteria) or newly diabetes diagnosed at the OGTT (ADA criteria) or diabetic patients with insulin requirement ≤ 0.3 unit / kg / day or without insulin treatment
- signed informed consent of patient and of one parent OR legal representative for minor subject
Exclusion Criteria:
- hypersensitivity to the active substances or to any of the excipients of Lumactfor -Ivacaftor
- lung and/or liver transplant patient
- Known diabetes with insulin treatment > 0.3 unit / kg / day
- patient pregnant or wishing to pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512119
France | |
Hôpitaux Universitaires de Strasbourg | |
Strasbourg, Alsace, France, 67000 | |
Centre Hospitalier Universitaire d'Angers | |
Angers, France, 49033 | |
Hôpital Renée Sabran | |
Giens, France, 83406 | |
Centre Hospitalier Lyon Sud | |
Lyon, France, 69000 | |
Hôpital NORD - Assistance Publique Hôpitaux de Marseille | |
Marseille, France, 13385 | |
Hôpital Arnaud de Villeneuve | |
Montpellier, France, 34295 | |
Hôpital Robert Debré | |
Paris, France, 75019 | |
American Memorial Hospital | |
Reims, France, 51092 | |
Clinique "Mucoviscidose" Presqu'île de Perharidy | |
Roscoff, France, 29684 | |
Hôpital Charles Nicolle | |
Rouen, France, 76031 | |
Hôpital FOCH | |
Suresnes, France, 92151 | |
Hôpital Bretonneau - CHRU de Tours | |
Tours, France, 37044 | |
Hôpital de Clocheville - CHRU de Tours | |
Tours, France, 37044 |
Responsible Party: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT03512119 |
Other Study ID Numbers: |
6403 |
First Posted: | April 30, 2018 Key Record Dates |
Last Update Posted: | November 24, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cystic fibrosis Glucose tolerance abnormalities CFTR corrector and potentiator |
Cystic Fibrosis Congenital Abnormalities Glucose Intolerance Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Ivacaftor Chloride Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |