Clinical trial NCT01484262: Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
Official title: Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 1344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetics (OADs), who need treatment intensification with insulin or liraglutide due to inadequate blood glucose control.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life)
timeFrame: At the end of the observational period (52 weeks)
Secondary outcomes:
measure: Total cost of patient's diseases
timeFrame: At the end of the observational period (52 weeks)
measure: Total cost of patient education
timeFrame: At the end of the observational period (52 weeks)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Lundershausen R, Muller S, Hashim M, Kienhofer J, Kipper S, Wilke T. Quality of Life, Glycemic Control, Safety and Tolerability Associated with Liraglutide or Insulin Initiation in Patients with Type 2 Diabetes in Germany: Results from the Prospective, Non-interventional LIBERTY Study. Exp Clin Endocrinol Diabetes. 2020 Mar;128(3):170-181. doi: 10.1055/a-0636-3961. Epub 2018 Aug 29.