Observational Study to Assess the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 for the Treatment of Diabetes

NCT ID: NCT00696163

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

24975 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-03-31

Brief Summary

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This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.

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

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A

biphasic insulin aspart 30

Intervention Type DRUG

Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion

Interventions

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biphasic insulin aspart 30

Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion

Intervention Type DRUG

Other Intervention Names

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NovoMix® 30 BIAsp30

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.

Exclusion Criteria

* Currently treated with NovoMix® 30
* Subjects who are unlikely to comply with protocol requirements
* Previously enrolled in this study
* Hypersensitivity to biphasic insulin aspart or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 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

Bangalore, , India

Site Status

Countries

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India

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-3555

Identifier Type: -

Identifier Source: org_study_id