Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)
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ClinicalTrials.gov Identifier: NCT00639626 |
Recruitment Status :
Terminated
(PI left the institution)
First Posted : March 20, 2008
Results First Posted : April 12, 2018
Last Update Posted : April 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis Related Diabetes | Drug: insulin detemir [rDNA origin] injection | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Use of Levemir® Improves Metabolic and Clinical Status in CFRD |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Levemir |
Drug: insulin detemir [rDNA origin] injection
Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
Other Name: Levemir |
- Blood Sugar [ Time Frame: 6 months ]
- Lean Body Mass [ Time Frame: 6 months ]

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Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639626
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
Principal Investigator: | Dana S. Hardin, MD | OSU, Nationwide Children's Hospital |
Responsible Party: | Nationwide Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00639626 |
Other Study ID Numbers: |
IRB07-00218 |
First Posted: | March 20, 2008 Key Record Dates |
Results First Posted: | April 12, 2018 |
Last Update Posted: | April 12, 2018 |
Last Verified: | March 2018 |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Insulin Detemir Hypoglycemic Agents Physiological Effects of Drugs |