This trial is active, not recruiting.

Conditions diabetes, diabetes mellitus, type 2
Treatments liraglutide, insulin
Sponsor Novo Nordisk A/S
Start date November 2011
End date October 2014
Trial size 1361 participants
Trial identifier NCT01484262, NN2211-3962, U1111-1123-5044


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.
Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.

Primary Outcomes

Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life)
time frame: At the end of the observational period (52 weeks)

Secondary Outcomes

Total cost of patient's diseases
time frame: At the end of the observational period (52 weeks)
Total cost of patient education
time frame: At the end of the observational period (52 weeks)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Novo Nordisk A/S.