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
PHASE2
62 participants
INTERVENTIONAL
2006-06-30
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Interventions
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NovoFine® needle 6 mm
NovoFine® needle 4 mm
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes
* Insulin treatment for more than ½ year
* BMI lesser than or equal to 19 kg/m2
* Last HbA1c taken within the last year lesser than 10.5%
* Girls: only prepubertal
* Boys: both pre pubertal and pubertal. Adults
* Type 1 and 2 diabetes
* Insulin treatment for more than ½ year
* BMI lesser than or equal to 23 kg/m2
* Last HbA1c taken within the last year lesser than 10.5%
Exclusion Criteria
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any).
* Skin disease at abdomen and/or thigh
6 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Aalborg, , Denmark
Novo Nordisk Investigational Site
Århus C, , Denmark
Countries
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References
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Birkebaek NH, Solvig J, Hansen B, Jorgensen C, Smedegaard J, Christiansen JS. A 4-mm needle reduces the risk of intramuscular injections without increasing backflow to skin surface in lean diabetic children and adults. Diabetes Care. 2008 Sep;31(9):e65. doi: 10.2337/dc08-0977. No abstract available.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2006-000174-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PDS322-1749
Identifier Type: -
Identifier Source: org_study_id
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