Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30

NCT ID: NCT00675493

Last Updated: 2016-02-19

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

942 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-01-31

Brief Summary

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This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.

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

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Interventions

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biphasic insulin aspart 30

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Intervention Type DRUG

Other Intervention Names

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NovoMix® 30

Eligibility Criteria

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Inclusion Criteria

* Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).

Exclusion Criteria

* Subjects currently being treated with biphasic insulin aspart 30
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
* Women who are pregnant or have the intention of becoming pregnant within next 6 months
* Children below 10 years of age
Minimum Eligible Age

10 Years

Maximum Eligible Age

75 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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Bucharest, , Romania

Site Status

Countries

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Romania

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-3567

Identifier Type: -

Identifier Source: org_study_id

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