An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment (Start)

January 6, 2017 updated by: Novo Nordisk A/S

An Observational, Prospective Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix® 30 (Biphasic Insulin Aspart) Treatment

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

509

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

  • Finland
      • Lahti, Finland, 15110
        • 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

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with type 2 diabetes.

Description

Inclusion Criteria:

  • Patients with Type 2 diabetes
  • Insulin-naive or previously treated by basal only insulin therapy

Exclusion Criteria:

  • Patients who are unlikely to comply with the protocol
  • Pregnancy or breastfeeding or intention of becoming pregnant

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 as well as dose alterations to be determined by the physician according to normal clinical evaluation
Other Names:
  • NovoMix® 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of serious adverse drug reactions, including major hypoglycaemic events
Time Frame: at 26 weeks
at 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of all hypoglycaemic events
Time Frame: at 26 weeks
at 26 weeks
HbA1c
Time Frame: at 12 weeks and 26 weeks
at 12 weeks and 26 weeks
Fasting plasma glucose at visits
Time Frame: at 12 weeks and 26 weeks
at 12 weeks 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

January 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (Estimate)

June 13, 2008

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1917

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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