Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin

NCT ID: NCT00676741

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

3809 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-05-31

Brief Summary

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The study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for the treatment type 2 diabetes.

Full acronym for this study: COMMIT - CLEAN SWITCH

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

insulin aspart

Intervention Type DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

B

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

C

insulin detemir

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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insulin aspart

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

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

insulin detemir

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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NovoRapid®

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes
* Patients treated with human soluble insulin, NPH insulin or premixed human insulin
* Patients willing to sign informed consent
* Selection of study participants at the discretion of the physician

Exclusion Criteria

* Subjects currently being treated with insulin aspart, insulin detemir or biphasic insulin aspart 30
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients
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

Bratislava, , Slovakia

Site Status

Countries

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Slovakia

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-3516

Identifier Type: -

Identifier Source: org_study_id