Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During Real-life Usage in Germany

Study Overview
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Brief Summary
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This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.

Official Title
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Insulin Detemir (Levemir®) Versus Isophane (NPH) Insulin (Protaphane®) in Combination With Oral Antidiabetic Agents (OAD) in Patients With Diabetes Mellitus Type 2 Comparing Treatment Satisfaction, Diabetes-related and General Health-related Quality of Life, as Well as Diabetes-control

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin detemir
* Drug: isophane human insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained from patient before first documentation of treatment in the observational study. Type 2 diabetes mellitus Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control No contraindication for use of Protaphane® or Levemir® Exclusion Criteria: None

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 detemir<br>* Observational study on treatment satisfaction of Levemir ® versus Protaphane® during real-life usage in Germany<br>* Other names: Levemir®;|
| B<br> | Drug: isophane human insulin<br>* Observational study on treatment satisfaction of Levemir ® versus Protaphane® during real-life usage in Germany<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment satisfaction (DTSQs and DTSQc) |  | over whole study duration, 24 weeks per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diabetes-related quality of life (ADDQoL) |  | over whole study duration, 24 weeks per patient | 
| general health-related quality of life (EQ-5D) |  | over whole study duration, 24 weeks per patient | 
| Body weight |  | over whole study duration, 24 weeks per patient | 
| metabolic control (HbA1c, fasting morning blood glucose) |  | over whole study duration, 24 weeks per patient | 
| Insulin dose |  | over whole study duration, 24 weeks per patient | 
| concomitant diabetes therapy (OADs) |  | over whole study duration, 24 weeks per patient | 
| Hypoglycemia |  | over whole study duration, 24 weeks per patient | 
| Adverse drug reactions, ADR |  | over whole study duration, 24 weeks per patient | 
| Serious adverse drug reactions, SADR |  | over whole study duration, 24 weeks per patient | 
| Pregnancy |  | over whole study duration, 24 weeks per patient |