Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

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

3421 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-10-31

Brief Summary

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This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

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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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Insulin detemir

insulin detemir

Intervention Type DRUG

Safety and effectiveness data collection in connection with the use of the drug.

Biphasic insulin aspart 30

biphasic insulin aspart 30

Intervention Type DRUG

Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.

Interventions

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insulin detemir

Safety and effectiveness data collection in connection with the use of the drug.

Intervention Type DRUG

biphasic insulin aspart 30

Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.

Intervention Type DRUG

Other Intervention Names

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NN304 Levemir®

Eligibility Criteria

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Inclusion Criteria

* After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
* Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Eligible Sex

ALL

Accepts Healthy Volunteers

No