Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin

NCT ID: NCT00775736

Last Updated: 2017-01-11

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

611 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-01-31

Brief Summary

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This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice

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 and safety data collection at the discretion of the physician following clinical practice

biphasic insulin aspart 50

Intervention Type DRUG

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

biphasic insulin aspart 70

Intervention Type DRUG

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

Interventions

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biphasic insulin aspart 30

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

Intervention Type DRUG

biphasic insulin aspart 50

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

Intervention Type DRUG

biphasic insulin aspart 70

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

Intervention Type DRUG

Other Intervention Names

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BIAsp

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus

Exclusion Criteria

* Known or suspected allergy to study product or related products.
* Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 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

Brussels, , Belgium

Site Status

Novo Nordisk Investigational Site

Luxembourg, , Luxembourg

Site Status

Countries

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Belgium Luxembourg

References

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Nobels F, D'Hooge D, Crenier L. Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: observational study results. Curr Med Res Opin. 2012 Jun;28(6):1017-26. doi: 10.1185/03007995.2012.695730. Epub 2012 Jun 11.

Reference Type RESULT
PMID: 22612579 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-3665

Identifier Type: -

Identifier Source: org_study_id

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