Status:
COMPLETED
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0....
Eligibility Criteria
Inclusion
- Children/adolescents with type 1 diabetes mellitus
- 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
- Pregnancy or desire to become pregnant
- 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
Key Trial Info
Start Date :
January 20 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 1998
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00872560
Start Date
January 20 1998
End Date
July 27 1998
Last Update
August 7 2018
Active Locations (1)
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1
Novo Nordisk Investigational Site
Chieti, Italy, 66100