Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin

Study Overview
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Brief Summary
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This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.

Official Title
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Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus

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 30


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Current treatment with human soluble insulin, insulin NPH or premixed human insulin The selection of the subjects will be at the discretion of the individual physician Exclusion Criteria: Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30 Previous enrolment in this study Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients. Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir

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: insulin aspart<br>* Intervention at the discretion of the physician<br>* Other names: NovoRapid®;|
| B<br> | Drug: insulin detemir<br>* Intervention at the discretion of the physician<br>|
| C<br> | Drug: biphasic insulin aspart 30<br>* Intervention at the discretion of the physician<br>|
| D<br> | Drug: insulin aspart<br>* Intervention at the discretion of the physician<br>* Other names: NovoRapid®;Drug: insulin detemir<br>* Intervention at the discretion of the physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c after switch from human insulin to modern insulin treatment |  | After 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment |  | After 12 and 24 weeks | 
| Postprandial glycaemic control as measured by PPG |  | After 12 and 24 weeks | 
| Glucose variability as measured by FPG |  | After 12 and 24 weeks | 
| Insulin dose and number of injections |  | After 12 and 24 weeks | 
| Body weight |  | After 12 and 24 weeks | 
| Number of hypoglycaemic events |  | During treatment | 
| Number of adverse drug reactions (ADR) |  | After 12 and 24 weeks |