Comparison of 2 NovoFine® Needles on the Reflux of Insulin
NCT ID: NCT00872560
Last Updated: 2018-08-07
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
PHASE3
60 participants
INTERVENTIONAL
1998-01-20
1998-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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NovoFine® needle 6 mm
NovoFine® needle 8 mm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Usage of NovoPen® 1.5 for at least 3 months
* Duration of insulin treatment more than 1 year
* Normal weight according to Tanner scales
* The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%
Exclusion Criteria
* Clinical relevant peripheral neuropathy as judged by the investigators
* Pronounced lipodystrophy in accordance with investigator's evaluation
* Use of drugs that can influence the trial
* Coagulation disorders (use of anti-coagulants)
* Serious, chronic diseases, making it highly unlikely that the subject can complete the trial
10 Years
17 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
Chieti, , Italy
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NEEDLEN/DCD/4/I
Identifier Type: -
Identifier Source: org_study_id
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