Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes (UPGRADE)

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

NovoMix® 30 UPGRADE (NovoMix® 30 Use for Progressed Glycemic Control in Realistic Administration to DiabEtes Mellitus): A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Efficacy and Safety Study in Patients Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1068

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient with type 1 and type 2 diabetes who are prescribed with NovoMix® 30

Description

Inclusion Criteria:

  • Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
  • Patient who signed on informed consent form

Exclusion Criteria:

  • Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
  • Patients who were previously enrolled in this study
  • Patients with a hypersensitivity to NovoMix® 30 or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming 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 30
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • NovoMix® 30
  • NovoLog® Mix 70/30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c change
Time Frame: at the end of study after 26 weeks
at the end of study after 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse drug reactions
Time Frame: during the study
during the study
Number of serious adverse events
Time Frame: during the study
during the study
Number of all major (daytime and nocturnal) hypoglycaemic events
Time Frame: during the study
during the study
Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection
Time Frame: during the study
during the study
Number of major hypoglycaemic events related to physical exercise of at least 30 min
Time Frame: during the study
during the study
Number of all minor (daytime and nocturnal) hypoglycaemic events
Time Frame: during the study
during the study
Weight (BMI) change
Time Frame: at the end of study after 26 weeks
at the end of study after 26 weeks
Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change
Time Frame: at the end of study after 26 weeks
at the end of study after 26 weeks
Percentage of patients reaching the target of HbA1c below or equal to 6.5%
Time Frame: at the end of study after 26 weeks
at the end of study after 26 weeks
Percentage of patients reaching the target of HbA1c below or equal to 7.0%
Time Frame: at the end of study after 26 weeks
at the end of study after 26 weeks
Percentage of patients reaching the physician's own target recommendation
Time Frame: at the end of study after 26 weeks
at the end of study after 26 weeks
Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level
Time Frame: at the end of study after 26 weeks
at the end of study after 26 weeks
Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level
Time Frame: at the end of study after 26 weeks
at the end of study after 26 weeks
Diabetes Fear of Self-Injection Questionnaire (D-FISQ)
Time Frame: at the end of study after 26 weeks
at the end of study after 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

May 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 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-3547

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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