Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

NCT ID: NCT00755833

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

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-04-30

Brief Summary

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This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.

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 50

Intervention Type DRUG

Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.

Interventions

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biphasic insulin aspart 50

Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.

Intervention Type DRUG

Other Intervention Names

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NovoMix® 50

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes treated with biphasic human insulin with or without metformin
* Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion Criteria

* Subjects with diagnosed type 1 diabetes mellitus
* Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
* Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
* Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
* Women of childbearing potential, who are pregnant, breast-feeding or intend to become 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

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-3674

Identifier Type: -

Identifier Source: org_study_id