Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin
Mix2Mix
1 other identifier
observational
611
2 countries
2
Brief Summary
This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Typical duration for all trials
2 active sites
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
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 17, 2008
CompletedFirst Posted
Study publicly available on registry
October 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJanuary 11, 2017
January 1, 2017
2.3 years
October 17, 2008
January 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period.
At baseline, 12 and 26 weeks.
Secondary Outcomes (5)
Number of all hypoglycaemic episodes.
At baseline, 12 and 26 weeks.
Number of all adverse drug reactions.
At baseline, 12 and 26 weeks.
HbA1c
at 12 and 26 weeks
Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels
at 12 and 26 weeks
Weight changes
at 12 and 26 weeks
Study Arms (1)
A
Interventions
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Eligibility Criteria
After the participating physicians' decision has been made to initiate NovoMix® therapy, any patient with type 2 diabetes who is currently treated with a human premix insulin therapy.
You may qualify if:
- Type 2 diabetes mellitus
You may not qualify if:
- Known or suspected allergy to study product or related products.
- Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (2)
Novo Nordisk Investigational Site
Brussels, 1070, Belgium
Novo Nordisk Investigational Site
Luxembourg, Luxembourg
Related Publications (1)
Nobels F, D'Hooge D, Crenier L. Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: observational study results. Curr Med Res Opin. 2012 Jun;28(6):1017-26. doi: 10.1185/03007995.2012.695730. Epub 2012 Jun 11.
PMID: 22612579RESULT
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
October 17, 2008
First Posted
October 20, 2008
Study Start
October 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 11, 2017
Record last verified: 2017-01