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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: liraglutide; Drug: insulin

• Registration Number: NCT01484262
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-14
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-02
• Primary Completion: 2014-10-31
• Study Completion: 2014-10-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1344

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liraglutide	liraglutide	-
Any insulin	insulin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Mainz, Germany