Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

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

A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia

This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

270

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

  • Slovenia
      • Ljubljana, Slovenia, SI-1000
        • 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

Type 2 diabetes patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 50 as new treatment and as part of routine out-patient care by the prescribing physician.

Description

Inclusion Criteria:

  • Type 2 diabetes treated with biphasic human insulin with or without metformin
  • Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion Criteria:

  • Subjects with diagnosed type 1 diabetes mellitus
  • Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
  • Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
  • Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
  • Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 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 50
Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.
Other Names:
  • NovoMix® 50

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: At 0, 3, 6, 9, 12 months
At 0, 3, 6, 9, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects achieving target HbA1c
Time Frame: At 0, 3, 6, 9, 12 months
At 0, 3, 6, 9, 12 months
Change in FPG (fasting plasma glucose)
Time Frame: At 0, 3, 6, 9, 12 months
At 0, 3, 6, 9, 12 months
Change in PPG (postprandial glucose)
Time Frame: At 0, 3, 6, 9, 12 months
At 0, 3, 6, 9, 12 months
Change in number of hypoglycaemic events
Time Frame: At 0, 3, 6, 9, 12 months
At 0, 3, 6, 9, 12 months
Change in insulin presentation
Time Frame: At 0, 3, 6, 9, 12 months
At 0, 3, 6, 9, 12 months
Dose and number of injections
Time Frame: At 0, 3, 6, 9, 12 months
At 0, 3, 6, 9, 12 months
Number of ADRs (adverse drug reaction)
Time Frame: At 0, 3, 6, 9, 12 months
At 0, 3, 6, 9, 12 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

September 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 19, 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-3674

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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