Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes
EFFECTIVE
EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice
1 other identifier
observational
2,308
1 country
1
Brief Summary
This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 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
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedOctober 31, 2016
October 1, 2016
1.3 years
June 13, 2008
October 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from baseline
After 6 months
Secondary Outcomes (8)
Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus
after 12 weeks and 26 weeks compared to baseline
Change in FPG (glucose variability)
after 12 weeks and 26 weeks compared to baseline
Change in PPG (postprandial control)
after 12 weeks and 26 weeks compared to baseline
Change in insulin dose and number of injections
at 12 weeks and 26 weeks of treatment
Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study
after 12 weeks and 26 weeks of treatment compared to baseline
- +3 more secondary outcomes
Study Arms (1)
A
Interventions
There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.
Eligibility Criteria
Type 1 and 2 diabetes
You may qualify if:
- Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
- HbA1c greater than 7%
- Informed Consent
You may not qualify if:
- Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
- Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Belgrade, 11 070, Serbia and Montenegro
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
June 13, 2008
First Posted
June 17, 2008
Study Start
June 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
October 31, 2016
Record last verified: 2016-10