Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients

NCT ID: NCT00834262

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

339 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

biphasic insulin aspart 30

Intervention Type DRUG

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

biphasic insulin aspart 50

Intervention Type DRUG

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

biphasic insulin aspart 70

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

biphasic insulin aspart 30

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

Intervention Type DRUG

biphasic insulin aspart 50

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

Intervention Type DRUG

biphasic insulin aspart 70

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NovoMix® 30

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible

Exclusion Criteria

* Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Kfar Saba, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BIASP-3669

Identifier Type: -

Identifier Source: org_study_id