Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: biphasic insulin aspart 30


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30 Patient who signed on informed consent form Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: NovoLog® Mix 70/30;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change |  | at the end of study after 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of all minor (daytime and nocturnal) hypoglycaemic events |  | during the study | 
| Weight (BMI) change |  | at the end of study after 26 weeks | 
| Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change |  | at the end of study after 26 weeks | 
| Percentage of patients reaching the target of HbA1c below or equal to 6.5% |  | at the end of study after 26 weeks | 
| Percentage of patients reaching the target of HbA1c below or equal to 7.0% |  | at the end of study after 26 weeks | 
| Percentage of patients reaching the physician's own target recommendation |  | at the end of study after 26 weeks | 
| Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level |  | at the end of study after 26 weeks | 
| Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level |  | at the end of study after 26 weeks | 
| Diabetes Fear of Self-Injection Questionnaire (D-FISQ) |  | at the end of study after 26 weeks |