Comparison of 2 NovoFine® Needles on the Reflux of Insulin

Diabetes Clinical Trial

Official title:

Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872560
• Other study ID #: NEEDLEN/DCD/4/I
• Status: Completed
• Phase: Phase 3
• Start date: January 20, 1998
• Est. completion date: July 27, 1998

Study information

• Verified date: August 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 0.30 mm on reflux of insulin back to the surface of cutis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 27, 1998
• Est. primary completion date: July 27, 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Delivery Systems
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• NovoFine® needle 6 mm

• NovoFine® needle 8 mm

Locations

Country	Name	City	State
Italy	Novo Nordisk Investigational Site	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weighing of reflux of insulin		6 seconds after injection
Secondary	Pain perception		after 6 weeks of treatment
Secondary	Number and severity of bleedings		after 6 weeks of treatment
Secondary	Reactions at injection sites		after 6 weeks of treatment

External Links

•   Clinical Trials at Novo Nordisk