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

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide; Drug: insulin

Study type: Observational

Funder types: Industry

Identifiers

NCT01484262

NN2211-3962

U1111-1123-5044 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,344 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,344 participants in 2 patient groups

Liraglutide

Treatment:

Drug: liraglutide

Any insulin

Treatment:

Drug: insulin