Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus in Romania
1 other identifier
observational
942
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.
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
Shorter than P25 for all trials
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
May 7, 2008
CompletedFirst Posted
Study publicly available on registry
May 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFebruary 19, 2016
February 1, 2016
8 months
May 7, 2008
February 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from baseline
For the duration of the study
Secondary Outcomes (8)
Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%
after 12 weeks and 24 weeks of treatment
Change in FPG (glucose variability)
after 12 weeks and 24 weeks of treatment
Change in PPG (postprandial control)
after 12 weeks and 24 weeks of treatment
Change in insulin dose and number of injections
at 12 weeks and 24 weeks of treatment
Change in oral antidiabetic drug therapy
after 12 weeks and 24 weeks of treatment
- +3 more secondary outcomes
Study Arms (1)
A
Interventions
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
Eligibility Criteria
Type 1 and type 2 diabetes patients inadequately controlled on human premixes
You may qualify if:
- Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).
You may not qualify if:
- Subjects currently being treated with biphasic insulin aspart 30
- Subjects who were previously enrolled in this study
- Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
- Women who are pregnant or have the intention of becoming pregnant within next 6 months
- Children below 10 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Bucharest, 010031, Romania
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
May 7, 2008
First Posted
May 9, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
February 19, 2016
Record last verified: 2016-02