Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes

NCT ID: NCT00699179

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

2308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-09-30

Brief Summary

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This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.

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

There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.

Interventions

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biphasic insulin aspart 30

There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to 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 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
* HbA1c greater than 7%
* Informed Consent

Exclusion Criteria

* Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
* Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months
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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Novo Nordisk Investigational Site

Belgrade, , Serbia and Montenegro

Site Status

Countries

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Serbia Serbia and Montenegro

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-3557

Identifier Type: -

Identifier Source: org_study_id