Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes
UPGRADE
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
1 other identifier
observational
1,068
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 19, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedOctober 31, 2016
October 1, 2016
1.7 years
August 19, 2008
October 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c change
at the end of study after 26 weeks
Secondary Outcomes (14)
Number of serious adverse drug reactions
during the study
Number of serious adverse events
during the study
Number of all major (daytime and nocturnal) hypoglycaemic events
during the study
Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection
during the study
Number of major hypoglycaemic events related to physical exercise of at least 30 min
during the study
- +9 more secondary outcomes
Study Arms (1)
A
Interventions
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Eligibility Criteria
Any patient with type 1 and type 2 diabetes who are prescribed with NovoMix® 30
You may qualify if:
- Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
- Patient who signed on informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Seoul, 137-920, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2008
First Posted
August 20, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
October 31, 2016
Record last verified: 2016-10