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Observational Study to Evaluate the Safety of Levemir® in Diabetes

NCT ID: NCT00706017

Last Updated: 2016-10-28

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

Total Enrollment

2282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-07-31

Brief Summary

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This observational study is conducted in North America. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® 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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

insulin detemir

Intervention Type DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Interventions

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insulin detemir

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

Other Intervention Names

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Levemir®

Eligibility Criteria

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Inclusion Criteria

* Type 1 or 2 diabetes
* Including newly diagnosed not on insulin or insulin analogue treatment
* Selection at the discretion of the physician
* Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older

Exclusion Criteria

* Current treatment with Levemir®
* Previously enrolled in the study
* Hypersensitivity to Levemir®
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

Mexico City, , Mexico

Site Status

Countries

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Mexico

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-3518

Identifier Type: -

Identifier Source: org_study_id