NCT00483769

Brief Summary

Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
Last Updated

June 7, 2007

Status Verified

February 1, 2007

First QC Date

June 6, 2007

Last Update Submit

June 6, 2007

Conditions

Cystic FibrosisGlucose Metabolism Disorders

Keywords

Cystis FibrosisGlucose intoleranceGlargineFEV1%

Outcome Measures

Primary Outcomes (1)

  • Reduction of decline in pulmonary function measured as FEV1

    One year

Secondary Outcomes (1)

  • Improvement of: Body Mass Index, Number of Lung Infections, HbA1c

    One Year

Interventions

GlargineDRUG

Eligibility Criteria

Age3 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients affected by Cystic Fibrosis who had shown glucose derangements.

You may not qualify if:

  • Patients with/without Cystic Fibrosis without glucose derangements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II

Naples, Naples, 80131, Italy

Location

Related Publications (1)

  • Franzese A, Spagnuolo MI, Sepe A, Valerio G, Mozzillo E, Raia V. Can glargine reduce the number of lung infections in patients with cystic fibrosis-related diabetes? Diabetes Care. 2005 Sep;28(9):2333. doi: 10.2337/diacare.28.9.2333. No abstract available.

    PMID: 16123520RESULT

Related Links

MeSH Terms

Conditions

Cystic FibrosisGlucose Metabolism DisordersGlucose Intolerance

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Adriana Franzese, Dr

    Federico II University

    STUDY DIRECTOR

  • Adriana Franzese, Dr

    University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center

    PRINCIPAL INVESTIGATOR

  • Adriana Franzese, Dr

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 7, 2007

Study Start

February 1, 2006

Study Completion

January 1, 2007

Last Updated

June 7, 2007

Record last verified: 2007-02

Locations

IT(1)