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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
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Nationwide Children's Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cystic Fibrosis Related Diabetes
Intervention: Drug: insulin detemir [rDNA origin] injection

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Reporting Groups
  Description
Levemir insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.

Participant Flow:   Overall Study
    Levemir
STARTED   0 
COMPLETED   0 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Reporting Groups
  Description
Levemir insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.

Baseline Measures
   Levemir 
Overall Participants Analyzed 
[Units: Participants]
 0 


  Outcome Measures

1.  Primary:   Blood Sugar   [ Time Frame: 6 months ]

2.  Secondary:   Lean Body Mass   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Julie Rice, RN
Organization: Nationwide Children's Hospital
phone: 6143553142
e-mail: julie.rice@nationwidechildrens.org


Publications:

Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00639626     History of Changes
Other Study ID Numbers: IRB07-00218
First Submitted: March 14, 2008
First Posted: March 20, 2008
Results First Submitted: May 15, 2015
Results First Posted: April 12, 2018
Last Update Posted: April 12, 2018