Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes
NCT ID: NCT00607737
Last Updated: 2012-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2008-01-31
2010-07-31
Brief Summary
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\- The patient serves as his own control, n=100 patients with diabetes
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
DIAGNOSTIC
QUADRUPLE
Study Groups
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1
insulin detemir
insulin detemir
3 cutaneous injections
2
saline
saline
3 cutaneous injections
Interventions
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insulin detemir
3 cutaneous injections
saline
3 cutaneous injections
Eligibility Criteria
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Inclusion Criteria
* HbA1c\<11 %
* BMI: 20-35 kg/m2
* Insulin detemir naive
* Basal insulin dose\>20E
Exclusion Criteria
* Current steroid or antiallergic treatment
* Lipodystrophy
* Change in insulin and antihypertensive treatment \< 30 days
* Smokers or alcoholics
18 Years
60 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Lise Tarnow
OTHER
Responsible Party
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Lise Tarnow
professor
Principal Investigators
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LIse Tarnow, md
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
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Steno Diabetes Center
Gentofte Municipality, , Denmark
Countries
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Related Links
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Other Identifiers
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EudraCT 2007-005677-59
Identifier Type: -
Identifier Source: secondary_id
APPLY
Identifier Type: -
Identifier Source: org_study_id