One Year Glargine Treatment in CFRD Children and Adolescents

Cystic Fibrosis Clinical Trial

Official title:

One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483769
• Other study ID #: 234-234-234-234-234
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2007
• Last updated: June 6, 2007
• Start date: February 2006
• Est. completion date: January 2007

Study information

• Verified date: February 2007
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

To evaluate the effect of glargine treatment on BMI, lung function, acute pulmonary infections and HbA1c in cystic fibrosis (CF) patients with different glucose derangements, eighty-seven patients were screened for glucose derangements with fasting hyperglycaemia or abnormalities at the oral glucose tolerance test. They were classified on the basis of a “gluco-score” ranging 0-5. Patients with gluco-score > 1 were treated with glargine. We report on the results of the first 20 patients who completed 12 months of treatment. BMI z-score, forced expiratory volume in the first second (FEV1), number of acute lung infections in the previous year and HbA1c were the study outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 20 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with/without Cystic Fibrosis without glucose derangements.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• Glargine

Locations

Country	Name	City	State
Italy	Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of decline in pulmonary function measured as FEV1		One year
Secondary	Improvement of: Body Mass Index, Number of Lung Infections, HbA1c		One Year

External Links

•   Cystic Fibrosis center of Naples is a service of tertiary cure for patients with Cystic Fibrosis regularly attending regional Cystic Fibrosis Center