Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes

October 27, 2016 updated by: Novo Nordisk A/S

Safety of NovoMix® 30 (Biphasic Insulin Aspart) Treatment in Patients With Type 2 Diabetes

This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

243

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

  • Norway
      • Rud, Norway, 1309
        • Novo Nordisk Investigational Site
  • Sweden
      • Farsta, Sweden, 123 47
        • 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

Study population type 2 diabetes strated on NovoMix® 30

Description

Inclusion Criteria:

  • Any patient with diabetes type 2 diabetes
  • Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin
  • Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products
  • Pregnancy, breast-feeding 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 to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • NovoMix® 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse drug reactions, including major hypoglycaemic events
Time Frame: after 12 and 26 weeks
after 12 and 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: at 12 and 26 weeks
at 12 and 26 weeks
Number of all hypoglycaemic events
Time Frame: in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks
in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks
Number of all adverse drug reactions
Time Frame: after 12 and 26 weeks
after 12 and 26 weeks
Variability in fasting plasma glucose (FPG) values and average FPG levels
Time Frame: at visits at 12 and 26 weeks
at visits at 12 and 26 weeks
Weight changes
Time Frame: at visits at 12 and 26 weeks
at visits 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.

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

March 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3512

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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