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

• Sponsor: Nationwide Children's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00639626
• Collaborator: Novo Nordisk A/S (Industry)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis Related Diabetes	Drug: insulin detemir [rDNA origin] injection	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• 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: Aug 1, 2008
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

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 Names: Levemir

Outcome Measures

Primary Outcome Measures

1. Blood Sugar [6 months]

Secondary Outcome Measures

1. Lean Body Mass [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Nationwide Children's Hospital
• Novo Nordisk A/S

Investigators

• Principal Investigator: Dana S. Hardin, MD, OSU, Nationwide Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cucinotta D, Arrigo T, De Luca F, Di Benedetto A, Lombardo F, Scoglio R, Sferlazzas C, Magazzù G. Metabolic and clinical events preceding diabetes mellitus onset in cystic fibrosis. Eur J Endocrinol. 1996 Jun;134(6):731-6.
• 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.
• Hardin DS, Moran A. Diabetes mellitus in cystic fibrosis. Endocrinol Metab Clin North Am. 1999 Dec;28(4):787-800, ix. Review.
• Moran A, Doherty L, Wang X, Thomas W. Abnormal glucose metabolism in cystic fibrosis. J Pediatr. 1998 Jul;133(1):10-17. Review.
• 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.
• 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.

• Responsible Party: Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT00639626
• Other Study ID Numbers: IRB07-00218
• First Posted: Mar 20, 2008
• Last Update Posted: Apr 12, 2018
• Last Verified: Mar 1, 2018

• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis; Insulin Detemir

Study Results

Participant Flow

Pre-assignment Detail	PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Arm/Group Title	Levemir
Arm/Group Description	insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
Period Title: Overall Study
STARTED	0
COMPLETED	0
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Levemir
Arm/Group Description	insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age (years) []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Blood Sugar
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Arm/Group Title	Levemir
Arm/Group Description	insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
Measure Participants	0

2. Secondary Outcome

Title	Lean Body Mass
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Arm/Group Title	Levemir
Arm/Group Description	insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
Arm/Group Title	Levemir
Arm/Group Description	insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
All Cause Mortality
	Levemir
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Levemir
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Levemir
	Affected / at Risk (%)	# Events
Total	0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.