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

NCT ID: NCT00639626

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-05-31

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 differently than other types of diabetes: CFRD with fasting hyperglycemia (FH), CFRD without FH and transient CFRD. The outcome of this consensus conference was the use of insulin as the only recommended treatment of CFRD. Although the conference report mandated treatment for CFRD with FH, treatment was not mandated for the other types of CFRD, the choice to treat was left to the clinician's discretion. However, insulin was the only recommended therapy for all types of CFRD. Although some clinicians have used basal bolus regimens as the insulin management, many still use NPH. Given the need for CF patients to eat many frequent meals and snacks to maintain their weight, use of NPH insulin rarely renders good glycemic control. A basal bolus regimen is much more physiologic and would allow good glycemic control even with frequent meals and snacks. To date, there are no studies documenting safety and efficacy of true basal insulin, or a basal bolus regimen. Furthermore, protein catabolism and excessive muscle loss has been well documented in CF patients, both in those with and those without, glucose intolerance. Studies by our group and others have documented that a major reason for the catabolism is resistance to insulin's anti-catabolic effects on protein turnover. Thus, there is potential clinical benefit of improving muscle mass and general health by insulin treatment even for CF patients who do not have fasting hyperglycemia. A non-peaking basal insulin would be the only reasonable choice, yet studies are lacking. Our overall goal is to study the safety and efficacy of LevemirTM for the improvement of glycemic control of patients with CFRD. As a second goal, we will explore the ability of this basal insulin to improve protein catabolism and muscle mass. The study will be conducted as a six month trial.

Conditions

Cystic Fibrosis Related Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levemir

Group Type: EXPERIMENTAL

insulin detemir [rDNA origin] injection

Intervention Type: DRUG

Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.

Interventions

insulin detemir [rDNA origin] injection

Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.

Intervention Type: DRUG

Other Intervention Names

Levemir

Eligibility 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).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana S. Hardin, MD

Role: PRINCIPAL_INVESTIGATOR

OSU, Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

Hardin DS, Moran A. Diabetes mellitus in cystic fibrosis. Endocrinol Metab Clin North Am. 1999 Dec;28(4):787-800, ix. doi: 10.1016/s0889-8529(05)70102-x.

Reference Type: BACKGROUND

PMID: 10609120 (View on PubMed)

Hardin DS, LeBlanc A, Para L, Seilheimer DK. Hepatic insulin resistance and defects in substrate utilization in cystic fibrosis. Diabetes. 1999 May;48(5):1082-7. doi: 10.2337/diabetes.48.5.1082.

Reference Type: BACKGROUND

PMID: 10331413 (View on PubMed)

Moran A, Milla C, Ducret R, Nair KS. Protein metabolism in clinically stable adult cystic fibrosis patients with abnormal glucose tolerance. Diabetes. 2001 Jun;50(6):1336-43. doi: 10.2337/diabetes.50.6.1336.

Reference Type: BACKGROUND

PMID: 11375334 (View on PubMed)

Moran A, Doherty L, Wang X, Thomas W. Abnormal glucose metabolism in cystic fibrosis. J Pediatr. 1998 Jul;133(1):10-17. doi: 10.1016/s0022-3476(98)70171-4. No abstract available.

Reference Type: BACKGROUND

PMID: 9672504 (View on PubMed)

Cucinotta D, Arrigo T, De Luca F, Di Benedetto A, Lombardo F, Scoglio R, Sferlazzas C, Magazzu G. Metabolic and clinical events preceding diabetes mellitus onset in cystic fibrosis. Eur J Endocrinol. 1996 Jun;134(6):731-6. doi: 10.1530/eje.0.1340731.

Reference Type: BACKGROUND

PMID: 8766944 (View on PubMed)

Nir M, Lanng S, Johansen HK, Koch C. Long-term survival and nutritional data in patients with cystic fibrosis treated in a Danish centre. Thorax. 1996 Oct;51(10):1023-7. doi: 10.1136/thx.51.10.1023.

Reference Type: BACKGROUND

PMID: 8977604 (View on PubMed)

Other Identifiers

IRB07-00218

Identifier Type: -

Identifier Source: org_study_id