Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication

Study Overview
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Brief Summary
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This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion

Official Title
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The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Study

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin aspart
* Drug: insulin detemir
* Drug: biphasic insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Exclusion Criteria: Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study. Subjects who were previously enrolled in this study. Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients. Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 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: insulin aspart<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: ANA;Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>Drug: biphasic insulin aspart<br>* Start 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 serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions |  | at baseline, 12 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice |  | at baseline, 12 weeks and 24 weeks | 
| Change in number of hypoglycaemic events |  | at baseline, 12 weeks and 24 weeks | 
| Change in HbA1c |  | at baseline, 12 weeks and 24 weeks | 
| Change in FPG (Fasting Plasma Glucose) |  | at baseline, 12 weeks and 24 weeks | 
| Change in PPG (postprandial glucose) |  | at baseline, 12 weeks and 24 weeks |