Comparison of 2 NovoFine® Needles on the Reflux of Insulin

NCT ID: NCT00872560

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-20

Study Completion Date

1998-07-27

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Delivery Systems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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NovoFine® needle 6 mm

Intervention Type DEVICE

NovoFine® needle 8 mm

Intervention Type DEVICE

Other Intervention Names

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NEEDLEN NEEDLEN

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Chieti, , Italy

Site Status

Countries

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Italy

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NEEDLEN/DCD/4/I

Identifier Type: -

Identifier Source: org_study_id

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