Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

NCT ID: NCT00709683

Last Updated: 2016-03-07

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

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-05-31

Brief Summary

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This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® 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

biphasic insulin aspart 30

Intervention Type DRUG

Start 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

Start 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

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes having failed on basal insulin with or without OAD
* HbA1c greater than 7.0%

Exclusion Criteria

* Subjects being unlikely to comply with protocol requirements
* Subjects who previously enrolled in this study
* Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
* Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method
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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Tunisia, , Tunisia

Site Status

Countries

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Tunisia

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-3572

Identifier Type: -

Identifier Source: org_study_id

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