Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin

NCT ID: NCT00569998

Last Updated: 2017-01-19

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

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-02-29

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.

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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NovoPen™ 4

Intervention Type DEVICE

NovoPen® 3

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Type 1 or type 2 diabetes mellitus for at least 12 months
* Adults at least 18 years
* Children/adolescents between 9-18 years
* HbA1c lesser than or equal to 11.0%

Exclusion Criteria

* Known or suspected alcohol or drug abuse
* Patients who are not able to read the user manual (may wear glasses if needed)
* Hypoglycaemic unawareness as judged by the investigator
* Visual and/or dexterity impairments as judged by the investigator
Minimum Eligible Age

9 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

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Cologne, , Germany

Site Status

Novo Nordisk Investigational Site

Leverkusen, , Germany

Site Status

Novo Nordisk Investigational Site

München, , Germany

Site Status

Novo Nordisk Investigational Site

Saint Ingbert, , Germany

Site Status

Novo Nordisk Investigational Site

Speyer, , Germany

Site Status

Novo Nordisk Investigational Site

Völklingen, , Germany

Site Status

Novo Nordisk Investigational Site

Catania, , Italy

Site Status

Novo Nordisk Investigational Site

Palermo, , Italy

Site Status

Novo Nordisk Investigational Site

Parma, , Italy

Site Status

Novo Nordisk Investigational Site

Roma, , Italy

Site Status

Novo Nordisk Investigational Site

Torino, , Italy

Site Status

Novo Nordisk Investigational Site

Almere Stad, , Netherlands

Site Status

Novo Nordisk Investigational Site

Amsterdam, , Netherlands

Site Status

Novo Nordisk Investigational Site

Heerlen, , Netherlands

Site Status

Novo Nordisk Investigational Site

Rotterdam, , Netherlands

Site Status

Novo Nordisk Investigational Site

The Hague, , Netherlands

Site Status

Novo Nordisk Investigational Site

Veldhoven, , Netherlands

Site Status

Novo Nordisk Investigational Site

Belfast, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Belfast, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Leeds, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Sidcup, , United Kingdom

Site Status

Countries

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Austria Germany Italy Netherlands United Kingdom

References

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Kolaczynski M, Chayer D. NovoPen® 4: perceived as superior in handling and acceptance versus HumaPen® Ergo and OptiPen® Pro in patients and healthcare professionals. Diabetes Technology & Therapeutics 2005; 7 (2): 390

Reference Type RESULT

Goke B, Gamba S, Erdtsieck RJ, Gilbey S, Schober E, Lytzen L, Kolaczynski M. NovoPen 4 offers superior performance, handling and acceptance compared with NovoPen 3 in insulin-treated diabetes patients. Diabetes Technology and Therapeutics 2005; 7 (2): 379-380

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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MS236-1544

Identifier Type: -

Identifier Source: org_study_id

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