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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
Enrollment 6

Recruitment Details  
Pre-assignment Details 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
Hide 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
Arm/Group Title Levemir
Hide 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 Number of Baseline Participants 0
Hide Baseline 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.
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title Blood Sugar
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Lean Body Mass
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
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
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levemir
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levemir
Affected / at Risk (%)
Total   0/6 (0.00%) 
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
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