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Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus

NCT ID: NCT00709475

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

747 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-10-31

Brief Summary

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This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries

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 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®, NN304

Eligibility Criteria

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Inclusion Criteria

* After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria

* Subjects who are unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for the final visit;
* Subjects currently being treated with insulin detemir;
* Subjects who previously enrolled in this study or studies related to NovoMix 30;
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.
Minimum Eligible Age

6 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

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-3551

Identifier Type: -

Identifier Source: org_study_id