Observational Study in Type 2 Diabetics Treated by an Intensive Insulin Treatment of Levemir®

NCT ID: NCT00806897

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

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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This study is conducted in Europe. The aim of this observational study is to gain practical experience with once daily Levemir® administration in type 2 diabetes patients who were previously treated with NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A

insulin detemir

Intervention Type DRUG

Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.

Interventions

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insulin detemir

Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.

Intervention Type DRUG

Other Intervention Names

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Levemir® NN304

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetic subjects on intensive insulin treatment (IIT)
* Eligibility for once daily insulin detemir administration
* Informed consent obtained before any observation-related activities

Exclusion Criteria

* Known or suspected allergy to insulin detemir
* Subjects previously enrolled in the observation
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months
Minimum Eligible Age

18 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

Vilnius, , Lithuania

Site Status

Countries

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Lithuania

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-3701

Identifier Type: -

Identifier Source: org_study_id