Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30

February 18, 2016 updated by: Novo Nordisk A/S

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus in Romania

This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

942

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

  • Romania
      • Bucharest, Romania, 010031

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

10 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 1 and type 2 diabetes patients inadequately controlled on human premixes

Description

Inclusion Criteria:

  • Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).

Exclusion Criteria:

  • Subjects currently being treated with biphasic insulin aspart 30
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
  • Women who are pregnant or have the intention of becoming pregnant within next 6 months
  • Children below 10 years of age

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: biphasic insulin aspart 30
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
Other Names:
  • NovoMix® 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c from baseline
Time Frame: For the duration of the study
For the duration of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in insulin dose and number of injections
Time Frame: at 12 weeks and 24 weeks of treatment
at 12 weeks and 24 weeks of treatment
Change in body weight
Time Frame: at 12 weeks and 24 weeks of treatment
at 12 weeks and 24 weeks of treatment
Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%
Time Frame: after 12 weeks and 24 weeks of treatment
after 12 weeks and 24 weeks of treatment
Change in FPG (glucose variability)
Time Frame: after 12 weeks and 24 weeks of treatment
after 12 weeks and 24 weeks of treatment
Change in PPG (postprandial control)
Time Frame: after 12 weeks and 24 weeks of treatment
after 12 weeks and 24 weeks of treatment
Change in oral antidiabetic drug therapy
Time Frame: after 12 weeks and 24 weeks of treatment
after 12 weeks and 24 weeks of treatment
Change in number of hypoglycaemic events
Time Frame: during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment
during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment
Number of adverse drug reactions (ADR)
Time Frame: after 12 weeks and 24 weeks of treatment
after 12 weeks and 24 weeks of treatment

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)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 9, 2008

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3567

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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