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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Nationwide Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00639626
First received: March 14, 2008
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Cystic Fibrosis Related Diabetes
Drug: insulin detemir [rDNA origin] injection
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Levemir® Improves Metabolic and Clinical Status in CFRD

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • To evaluate the effectiveness of Levemir to improve glycemic control in patients who have CFRD. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the metabolic effects of Levemir and the effect on body weight and lean tissue mass. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639626

Contacts
Contact: Julie Rice, BSN, RN 614-355-3142 julie.rice@nationwidechildrens.org
Contact: Megan Reynolds 614-722-4934 megan.reynolds@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Julie Rice, BSN, RN    614-355-3142    julie.rice@nationwidechildrens.org   
Sponsors and Collaborators
Nationwide Children's Hospital
Novo Nordisk A/S
Investigators
Principal Investigator: Dana S. Hardin, MD OSU, Nationwide Children's Hospital
  More Information

Publications:
Responsible Party: Dana S. Hardin, MD Associate Professor, The Ohio State University, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00639626     History of Changes
Other Study ID Numbers: IRB07-00218
Study First Received: March 14, 2008
Last Updated: August 10, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cystic Fibrosis
Diabetes Mellitus
Fibrosis
Digestive System Diseases
Endocrine System Diseases
Genetic Diseases, Inborn
Glucose Metabolism Disorders
Infant, Newborn, Diseases
Lung Diseases
Metabolic Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014