Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment

NCT ID: NCT00865397

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

1032 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-05-31

Brief Summary

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This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.

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_CONTROL

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

* Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
* Patient willing to sign informed consent
* Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels

Exclusion Criteria

* Subjects with diagnosed type 1 diabetes mellitus
* Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
* Subjects with hypersensitivity to Levemir® or to any of the ingredients
* Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 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

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Countries

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Hungary

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-3699

Identifier Type: -

Identifier Source: org_study_id