Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes (INTENSIV)

June 23, 2014 updated by: Novo Nordisk A/S

Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

619

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male and female above 18 years with type 2 diabetes

Description

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1c over 7%
  • No contraindication with NovoMix® 70

Exclusion Criteria:

  • Type 1 diabetes
  • Subjects participating in a clinical trial or another observational study
  • Subjects under previous basis-bolus insulin therapy
  • Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method

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
Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation
Other Names:
  • NovoMix® 70

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of major and minor hypoglycaemic events and adverse events
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 3 months
3 months
PPBG
Time Frame: 3 months
3 months
FBG
Time Frame: 3 months
3 months

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.

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

May 1, 2008

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (ESTIMATE)

June 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3576

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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