Status:
TERMINATED
Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Cystic Fibrosis Related Diabetes
Eligibility:
All Genders
16-45 years
Phase:
PHASE2
PHASE3
Brief 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).
Detailed Description
Cystic fibrosis (CF) related diabetes (CFRD) and glucose intolerance affects more than 50%-75% of teens and adults with CF. The 1998 North American CF Foundation on CFRD categorized the disease differ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00639626
Start Date
August 1 2008
End Date
May 1 2010
Last Update
April 12 2018
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205