Observational Study to Observe the Safety of Levemir® Treatment in Patients With Type 2 Diabetes

NCT ID: NCT00735501

Last Updated: 2014-10-29

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

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-05-31

Brief Summary

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This observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.

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

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

insulin detemir

Intervention Type DRUG

Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation

Interventions

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insulin detemir

Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation

Intervention Type DRUG

Other Intervention Names

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Levemir®

Eligibility Criteria

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Inclusion Criteria

* Any patient with type 2 diabetes
* Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin)
* Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria

* Known or suspected allergy to study product(s) or related products.
* Pregnancy or breastfeeding or intention of becoming pregnant within the next 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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Copenhagen S, , Denmark

Site Status

Stockholm, , Sweden

Site Status

Countries

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Denmark Sweden

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1938

Identifier Type: -

Identifier Source: org_study_id

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