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Observational Study to Evaluate the Safety of Levemir® in Patients With Diabetes

NCT ID: NCT01545791

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

1037 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-02-29

Brief Summary

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This study is conducted in Europe. The aim of the study is to observe the safety of insulin detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.

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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Insulin detemir users

insulin detemir

Intervention Type DRUG

Administered once or twice daily depending on patients' needs. Dose adjusted for each patient at the discretion of their treating physician

Interventions

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insulin detemir

Administered once or twice daily depending on patients' needs. Dose adjusted for each patient at the discretion of their treating physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Any patient with type 1 or type 2 diabetes mellitus, including newly diagnosed patients who had never received insulin or an insulin analogue before

Exclusion Criteria

* Patients whom the physician considered might be noncompliant for any reason; for example, uncooperative attitude, inability to return for the final visit and similar
* Patients previously enrolled in this study
* Patients with a hypersensitivity to insulin detemir
Maximum Eligible Age

110 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

Dublin, , Ireland

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Countries

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Ireland United Kingdom

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1952

Identifier Type: -

Identifier Source: org_study_id