Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2

Study Overview
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Brief Summary
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This study is conducted in Europe. The intention of this health service research study is to obtain data from daily routine to evaluate the quality of life and the costs of the disease for patients with type 2 diabetes mellitus.

Official Title
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Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any study-related activities. (Study-related activities are any procedures related to recording of data according to the protocol) Patients willing and able to give signed consent on matching patient data with sick fund data Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (Victoza®) due to inadequate blood glucose control Patient is a member of the involved sick fund (AOK Plus) Exclusion Criteria: Known or suspected contra-indication to the relevant study product according to current SPC Previous participation in this study History of type 1 diabetes mellitus Previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days) Previous treatment with liraglutide History of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis Progressive fatal disease Any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse Patients without legal capacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Liraglutide<br> | Drug: liraglutide<br>* Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.<br>|
| Any insulin<br> | Drug: insulin<br>* Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life) |  | At the end of the observational period (52 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cost of patient's diseases |  | At the end of the observational period (52 weeks) | 
| Total cost of patient education |  | At the end of the observational period (52 weeks) |