Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

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: 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 Exclusion Criteria: 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

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>* 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.<br>* Other names: NovoMix® 30;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline |  | After 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in body weight and waist circumference |  | at 12 weeks and 26 weeks of treatment compared to baseline | 
| Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits |  | at 12 weeks and 26 weeks of treatment compared to baseline | 
| Number of adverse drug reactions (ADR) |  | after 12 weeks and 26 weeks of treatment |