Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes

NCT ID: NCT00771680

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

10408 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-07-31

Brief Summary

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This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.

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 at the discretion of the physician following clinical practice

biphasic insulin aspart 30

Intervention Type DRUG

Start dose and frequency at the discretion of the physician following clinical practice

insulin aspart

Intervention Type DRUG

Start dose and frequency at the discretion of the physician following clinical practice

Interventions

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insulin detemir

Start dose and frequency at the discretion of the physician following clinical practice

Intervention Type DRUG

biphasic insulin aspart 30

Start dose and frequency at the discretion of the physician following clinical practice

Intervention Type DRUG

insulin aspart

Start dose and frequency at the discretion of the physician following clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

Exclusion Criteria

* In accordance with approved label
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

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Kiev, , Ukraine

Site Status

Countries

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Russia Ukraine

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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INS-3655

Identifier Type: -

Identifier Source: org_study_id