Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to find out if Levemir® (a long acting or basal insulin) is safe and effective in treating cystic fibrosis related diabetes (CFRD).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin Detemir

Criteria

Inclusion Criteria:

• Patients diagnosed with CFRD by oral glucose tolerance test (OGTT) who are medically stable. Medical stability will be defined as:

• No hospital admission for six weeks or more before the study

• No oral or intravenous antibiotics for at least six weeks preceding the study (subjects will be allowed to use low doses of inhaled corticosteroids).

Exclusion Criteria:

• Use of oral or intravenous corticosteroid medications within six weeks of the study.

• Evidence of clinically significant liver disease.

• Colonization with Burkholderia cepacia.

• Colonization with Aspergillus.

• Pregnancy.

• Medically unstable (stability defined above).