Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes

NCT ID: NCT00700830

Last Updated: 2014-08-15

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

1976 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-09-30

Brief Summary

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This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.

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_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A

insulin detemir

Intervention Type DRUG

Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation

Interventions

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insulin detemir

Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation

Intervention Type DRUG

Other Intervention Names

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Levemir®

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities
* Type 2 diabetes
* HbA1c between 7-9%
* Insulin naive
* Inadequate control with oral antidiabetics therapy as judged by investigator

Exclusion Criteria

* Patients with type 1 diabetes
* Hypersensitivity to Levemir® or to any of the excipients
* Pregnancy, or desire of pregnancy within next 6 months
* HbA1c greater than or equal to 9%
* Known or suspected allergy to the trial product or to any of the excipients
* Subjects who are unlikely to comply with protocol
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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Algiers, , Algeria

Site Status

Countries

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Algeria

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-3571

Identifier Type: -

Identifier Source: org_study_id

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