Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes

NCT ID: NCT00737776

Last Updated: 2016-10-31

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

1068 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-01-31

Brief Summary

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This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 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

biphasic insulin aspart 30

Intervention Type DRUG

Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Interventions

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biphasic insulin aspart 30

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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NovoMix® 30 NovoLog® Mix 70/30

Eligibility Criteria

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Inclusion Criteria

* Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
* Patient who signed on informed consent form

Exclusion Criteria

* Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
* Patients who were previously enrolled in this study
* Patients with a hypersensitivity to NovoMix® 30 or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
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

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-3547

Identifier Type: -

Identifier Source: org_study_id