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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484262
• Other study ID #: NN2211-3962
• Secondary ID: U1111-1123-5044
• Status: Completed
• Start date: November 14, 2011
• Est. completion date: October 31, 2014

Study information

• Verified date: October 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1344
• Est. completion date: October 31, 2014
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.
• insulin
Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lundershausen R, Müller S, Hashim M, Kienhöfer 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, No — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total cost of patient's diseases		At the end of the observational period (52 weeks)
Secondary	Total cost of patient education		At the end of the observational period (52 weeks)

External Links

•   Clinical Trials at Novo Nordisk