Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

Official Title
-----------------
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label Exclusion Criteria: Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir Subjects who were previously enrolled in this study Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin detemir<br> | Drug: insulin detemir<br>* Safety and effectiveness data collection in connection with the use of the drug.<br>* Other names: Levemir®;|
| Biphasic insulin aspart 30<br> | Drug: biphasic insulin aspart 30<br>* Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions (SADRs) |  | after 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all minor hypoglycaemic events |  | during 4 weeks preceding each visit | 
| Number of all major hypoglycaemic events |  | during 13 weeks preceding each visit | 
| HbA1c |  | after 26 weeks | 
| Percentage of subjects to reach HbA1c below 7.0% |  | after 13 weeks and 26 weeks | 
| The effect on glycaemic control as measured by FPG (fasting plasma glucose) |  | after 13 weeks and 26 weeks | 
| The effect on glycamic control as measured by PG profile |  | after 13 weeks and 26 weeks | 
| Change in body weight |  | after 13 weeks and 26 weeks |