ClinicalTrials.Veeva

Menu

Comparison of 2 NovoFine® Needles on the Reflux of Insulin

Novo Nordisk logo

Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 1
Diabetes
Delivery Systems

Treatments

Device: NovoFine® needle 6 mm
Device: NovoFine® needle 8 mm

Study type

Interventional

Funder types

Industry

Identifiers

NCT00872560
NEEDLEN/DCD/4/I

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems