Skip to main content
OpenTrials
Completed

NCT Number: NCT00737776

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Seoul, 137-920, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart 30

Drug

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

Primary outcomes

  1. HbA1c change

    Time frame: at the end of study after 26 weeks

Secondary outcomes

  1. Number of serious adverse drug reactions

    Time frame: during the study

  2. Number of serious adverse events

    Time frame: during the study

  3. Number of all major (daytime and nocturnal) hypoglycaemic events

    Time frame: during the study

  4. Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection

    Time frame: during the study

  5. Number of major hypoglycaemic events related to physical exercise of at least 30 min

    Time frame: during the study

  6. Number of all minor (daytime and nocturnal) hypoglycaemic events

    Time frame: during the study

  7. Weight (BMI) change

    Time frame: at the end of study after 26 weeks

  8. Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change

    Time frame: at the end of study after 26 weeks

  9. Percentage of patients reaching the target of HbA1c below or equal to 6.5%

    Time frame: at the end of study after 26 weeks

  10. Percentage of patients reaching the target of HbA1c below or equal to 7.0%

    Time frame: at the end of study after 26 weeks

  11. Percentage of patients reaching the physician's own target recommendation

    Time frame: at the end of study after 26 weeks

  12. Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level

    Time frame: at the end of study after 26 weeks

  13. Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level

    Time frame: at the end of study after 26 weeks

  14. Diabetes Fear of Self-Injection Questionnaire (D-FISQ)

    Time frame: at the end of study after 26 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: UPGRADE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 20, 2008
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.