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Observational Study of NovoPen® 4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

NCT ID: NCT00806858

Last Updated: 2016-11-23

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

Total Enrollment

526 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-07-31

Brief Summary

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This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.

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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Study Time Perspective

PROSPECTIVE

Study Groups

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A

NovoPen® 4

Intervention Type DEVICE

Insulin administration by means of a NovoPen® 4 pen device

Interventions

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NovoPen® 4

Insulin administration by means of a NovoPen® 4 pen device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any subject with Type 1 or Type 2 diabetes and accepting to use NovoPen® 4. The selection will be at the discretion of the individual physician.
* A study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations

Exclusion Criteria

* Subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit
* Subjects with known or suspected allergy to any insulin or any of its excipients
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

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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MS236-3663

Identifier Type: -

Identifier Source: org_study_id