An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment

NCT ID: NCT00696995

Last Updated: 2017-01-09

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

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-09-30

Brief Summary

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This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes 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 as well as dose alterations to be determined by the physician according to normal clinical evaluation

Interventions

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biphasic insulin aspart 30

Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation

Intervention Type DRUG

Other Intervention Names

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NovoMix® 30

Eligibility Criteria

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Inclusion Criteria

* Patients with Type 2 diabetes
* Insulin-naive or previously treated by basal only insulin therapy

Exclusion Criteria

* Patients who are unlikely to comply with the protocol
* Pregnancy or breastfeeding or intention of becoming pregnant
Maximum Eligible Age

99 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

Lahti, , Finland

Site Status

Countries

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Finland

References

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Makela JK, Schmuser C, Askonen K, Saukkonen T. Starting or switching to biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes: a multicenter, observational, primary care study conducted in Finland. Diabetes Res Clin Pract. 2012 Jan;95(1):10-8. doi: 10.1016/j.diabres.2011.06.006. Epub 2011 Nov 9.

Reference Type RESULT
PMID: 22078072 (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-1917

Identifier Type: -

Identifier Source: org_study_id

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