Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin (Mix2Mix)

January 10, 2017 updated by: Novo Nordisk A/S

Observational Study Evaluating Safety in Patients With Type 2 Diabetes Treated With NovoMix® 30 or NovoMix® 50 or NovoMix®70 (Biphasic Insulin Aspart)

This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

611

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Novo Nordisk Investigational Site
  • Luxembourg
      • Luxembourg, Luxembourg
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

After the participating physicians' decision has been made to initiate NovoMix® therapy, any patient with type 2 diabetes who is currently treated with a human premix insulin therapy.

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus

Exclusion Criteria:

  • Known or suspected allergy to study product or related products.
  • Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: biphasic insulin aspart 30
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Other Names:
  • BIAsp
Drug: biphasic insulin aspart 50
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Drug: biphasic insulin aspart 70
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period.
Time Frame: At baseline, 12 and 26 weeks.
At baseline, 12 and 26 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of all hypoglycaemic episodes.
Time Frame: At baseline, 12 and 26 weeks.
At baseline, 12 and 26 weeks.
Number of all adverse drug reactions.
Time Frame: At baseline, 12 and 26 weeks.
At baseline, 12 and 26 weeks.
HbA1c
Time Frame: at 12 and 26 weeks
at 12 and 26 weeks
Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels
Time Frame: at 12 and 26 weeks
at 12 and 26 weeks
Weight changes
Time Frame: at 12 and 26 weeks
at 12 and 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3665

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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