Comparison of 2 NovoFine® Needles on the Reflux of Insulin

Novo Nordisk A/S60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1 Delivery Systems

Interventions

NovoFine® needle 6 mmDEVICE

NovoFine® needle 8 mmDEVICE

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Chieti, Italy

Outcomes

Primary Outcomes

Weighing of reflux of insulin

Time frame: 6 seconds after injection

Secondary Outcomes

Pain perception

Time frame: after 6 weeks of treatment

Number and severity of bleedings

Time frame: after 6 weeks of treatment

Reactions at injection sites

Time frame: after 6 weeks of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.