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NCT03512119: GLUCORRECTOR
Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor
trial testing Lumacaftor-Ivacaftor treatment in Cystic Fibrosis Homozygous for Phe 508 Del CFTR in 55 participants. Completed in 10 April 2019.
10 April 2019
Quick facts
| Lead sponsor | University Hospital, Strasbourg, France |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 55 |
| Start date | 11 February 2016 |
| Primary completion | 10 April 2019 |
| Estimated completion | 10 April 2019 |
| Sites | 13 locations across France |
Drugs / interventions tested
- Lumacaftor-Ivacaftor treatment — full drug profile →
Conditions studied
- Cystic Fibrosis Homozygous for Phe 508 Del CFTR — all drugs for Cystic Fibrosis Homozygous for Phe 508 Del CFTR →
- Glucose Intolerance or Newly Diagnosis Diabetes — all drugs for Glucose Intolerance or Newly Diagnosis Diabetes →
Sponsor
University Hospital, Strasbourg, France
Who can join
12 and older, any sex, with Cystic Fibrosis Homozygous for Phe 508 Del CFTR or Glucose Intolerance or Newly Diagnosis Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03512119
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03512119 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Strasbourg, France
- Last refreshed: 24 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03512119.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing