Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles

NCT ID: NCT00871416

Last Updated: 2017-02-28

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-04-09

Study Completion Date

1997-07-18

Brief Summary

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This trial is conducted in Europe. The primary aim of this clinical trial is to locate and compare simulated insulin injections (injections of sterile atmospheric air) in normal weight and obese patients with diabetes mellitus. Injections are done with 6 mm and 12 mm needles with and without lifting of skin fold at different injection sites.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 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 12 mm

Intervention Type DEVICE

Other Intervention Names

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NEEDLEN NEEDLEN

Eligibility Criteria

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Inclusion Criteria

* Diabetes mellitus
* Use NovoPen®, NovoPen® 1.5, NovoPen® 3, NovoLet® 1.5 or NovoLet® 3 for at least 3 months
* Body mass index (BMI) for normal weight between 19-25 kg/m2
* Body mass index (BMI) for obese between 25-33 kg/m2

Exclusion Criteria

* Pregnancy or plans thereof
* Local reactions on injection sites
* Acute, severe infection diseases
* Coagulation disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Aarhus, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NEEDLEN/DCD/3/DK

Identifier Type: -

Identifier Source: org_study_id

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