Comparison of 2 NovoFine® Needles on the Reflux of Insulin

August 3, 2018 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Chieti, Italy, 66100
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weighing of reflux of insulin Time Frame: 6 seconds after injection	6 seconds after injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain perception Time Frame: after 6 weeks of treatment	after 6 weeks of treatment
Number and severity of bleedings Time Frame: after 6 weeks of treatment	after 6 weeks of treatment
Reactions at injection sites Time Frame: after 6 weeks of treatment	after 6 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 1998

Primary Completion (ACTUAL)

July 27, 1998

Study Completion (ACTUAL)