Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment

NCT ID: NCT01548235

Last Updated: 2017-01-06

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

423 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-04-30

Brief Summary

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This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.

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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BIAsp 30 users

biphasic insulin aspart 30

Intervention Type DRUG

Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.

Interventions

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biphasic insulin aspart 30

Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes
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

Copenhagen S, , Denmark

Site Status

Countries

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Denmark

References

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Breum L, Almdal T, Eiken P, Lund P, Christiansen E; Danish BIAsp Study Group. Initiating or switching to biphasic insulin aspart 30/70 therapy in subjects with type 2 diabetes mellitus. An observational study. Rev Diabet Stud. 2008 Fall;5(3):154-62. doi: 10.1900/RDS.2008.5.154. Epub 2008 Nov 10.

Reference Type RESULT
PMID: 19099087 (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-1812

Identifier Type: -

Identifier Source: org_study_id

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