NCT00639626

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
8 years until next milestone

Results Posted

Study results publicly available

April 12, 2018

Completed
Last Updated

April 12, 2018

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

March 14, 2008

Results QC Date

May 15, 2015

Last Update Submit

March 14, 2018

Conditions

Cystic Fibrosis Related Diabetes

Outcome Measures

Primary Outcomes (1)

  • Blood Sugar

    6 months

Secondary Outcomes (1)

  • Lean Body Mass

    6 months

Study Arms (1)

Levemir

EXPERIMENTAL
Drug: insulin detemir [rDNA origin] injection

Interventions

insulin detemir [rDNA origin] injectionDRUG

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

Also known as: Levemir
Levemir

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (6)

  • 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.

    PMID: 10609120BACKGROUND

  • 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.

    PMID: 10331413BACKGROUND

  • 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.

    PMID: 11375334BACKGROUND

  • 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.

    PMID: 9672504BACKGROUND

  • 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.

    PMID: 8766944BACKGROUND

  • 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.

    PMID: 8977604BACKGROUND

MeSH Terms

Interventions

Insulin DetemirInjections

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDrug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Julie Rice, RN
Organization
Nationwide Children's Hospital
julie.rice@nationwidechildrens.org
6143553142

Study Officials

  • Dana S. Hardin, MD

    OSU, Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 20, 2008

Study Start

August 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

April 12, 2018

Results First Posted

April 12, 2018

Record last verified: 2018-03

Locations

US(1)