Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 Diabetes
A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix® 30 FlexPen® as Monotherapy, or in Combination With OHA, in Treatment of Type 2 Diabetic Patients in Routine Clinical Practice: A Post-Marketing Surveillance Study
1 other identifier
observational
1,584
1 country
1
Brief Summary
This study is conducted in Asia. The aim of this observational study is to evaluate safety, efficacy and convenience in using NovoMix® 30 FlexPen® in type 2 diabetes under normal clinical practice conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2007
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
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedDecember 13, 2016
December 1, 2016
10 months
July 14, 2008
December 12, 2016
Conditions
Outcome Measures
Primary Outcomes (6)
Change in HbA1c
after 12 weeks of therapy
Change in post-prandial glucose (PPG)
after 12 weeks of therapy
Change in fasting plasma glucose (FPG)
after 12 weeks of therapy
Change in prandial glucose increment (PGI)
after 12 weeks of therapy
Incidence of hypoglycaemia and other adverse drug reaction
after 12 weeks of therapy
Patient and doctor's convenience
after 12 weeks of therapy
Secondary Outcomes (2)
Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practice
For the duration of the study
Patient satisfaction on devices
after 12 weeks of treatment
Study Arms (1)
A
Interventions
No intervention is done. For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation
Eligibility Criteria
All patients with type 2 diabetes, inadequately controlled on their current therapy, who are prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labelling.
You may qualify if:
- All patients with type 2 diabetes, not adequately controlled on their current therapy, who were prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labeling, are eligible for the survey.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Jakarta, 12520, Indonesia
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
July 14, 2008
First Posted
July 15, 2008
Study Start
February 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
December 13, 2016
Record last verified: 2016-12