Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGliraglutide
Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.
DRUGinsulin
Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
Germany
Outcome results
None listed