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An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries

NCT ID: NCT00842192

Last Updated: 2016-12-07

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

2155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-08-31

Brief Summary

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This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.

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

Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.

Interventions

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insulin detemir

Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.

Intervention Type DRUG

Other Intervention Names

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NN304 Levemir®

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 who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria

* Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin
* 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 6 months. Women of childbearing potential who are not using adequate contraceptive methods
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

Kfar Saba, , Israel

Site Status

Novo Nordisk Investigational Site

Amman, , Jordan

Site Status

Novo Nordisk Investigational Site

Amman, , Lebanon

Site Status

Novo Nordisk Investigational Site

Karachi, , Pakistan

Site Status

Countries

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Israel Jordan Lebanon Pakistan

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-3735

Identifier Type: -

Identifier Source: org_study_id