Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients

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 safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.

Official Title
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A Multi Centre, Open Label, Non-Randomized, Non Interventional, Observational Study on the Safety and Efficacy of Biphasic Insulin Aspart (NovoMix® 30, NovoMix® 50 and NovoMix® 70 or Combinations) in Type 2 Diabetes Mellitus Patients

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: biphasic insulin aspart 30
* Drug: biphasic insulin aspart 50
* Drug: biphasic insulin aspart 70


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible Exclusion Criteria: Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label. Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years

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: NovoMix® 30;Drug: biphasic insulin aspart 50<br>* Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>Drug: biphasic insulin aspart 70<br>* Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all hypoglycaemic episodes |  | during 13 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse drug reactions |  | during 13 weeks of treatment | 
| Number of adverse events |  | during 13 weeks of treatment | 
| Number of all major hypoglycaemic (daytime and nocturnal) episodes |  | during 13 weeks of treatment | 
| Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes |  | during 13 weeks of treatment | 
| Number of major hypoglycaemic episodes related to omission of a meal after injection |  | during 13 weeks of treatment | 
| Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration |  | during 13 weeks of treatment | 
| Weight (BMI) change |  | at the end of the study after 13 weeks of treatment | 
| HbA1c change |  | at the end of the study after 13 weeks of treatment | 
| Percentage of patients reaching the target of HbA1c of 7.0% or less |  | at the end of the study after 13 weeks of treatment | 
| Variability in fasting blood glucose values and average (mean) fasting blood glucose level |  | at the end of the study after 13 weeks of treatment | 
| Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level |  | at the end of the study after 13 weeks of treatment |