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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The study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for the treatment type 2 diabetes. Full acronym for this study: COMMIT - CLEAN SWITCH

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) or Levemir® (Insulin Detemir) - for Treatment of Diabetes Mellitus

Conditions
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Diabetes, Diabetes Mellitus, Type 2

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes Patients treated with human soluble insulin, NPH insulin or premixed human insulin Patients willing to sign informed consent Selection of study participants at the discretion of the physician Exclusion Criteria: Subjects currently being treated with insulin aspart, insulin detemir or biphasic insulin aspart 30 Subjects who were previously enrolled in this study Subjects with a hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients

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>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: NovoRapid®;|
| B<br> | Drug: biphasic insulin aspart 30<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>|
| C<br> | Drug: insulin detemir<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 |
| --- | --- | --- |
| Metabolic control measured as HbA1c |  | for the duration of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5% |  | after 12 weeks and 24 weeks | 
| Change in FPG (glucose variability) |  | after 12 weeks and 24 weeks | 
| Change in PPG (postprandial control) |  | after 12 weeks and 24 weeks | 
| Change in insulin dose and number of injections |  | after 12 weeks and 24 weeks | 
| Change in oral antidiabetic drug therapy |  | after 12 weeks and 24 weeks | 
| Change in body weight |  | after 12 weeks and 24 weeks | 
| Change in number of hypoglycaemic events during 4 weeks proceeding routine visits |  | after 12 weeks and 24 weeks | 
| Number of adverse drug reactions (ADR) |  | after 12 weeks and 24 weeks |