Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe

Completed

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

• Registration Number: NCT01890993
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-07-02
• Study Start: 2013-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 952

Inclusion Criteria

• Patients treated with liraglutide or DPP-4 inhibitors, according to license in respective participating country with data available for 12 (+/- 2) months

Exclusion Criteria

• Patients treated with liraglutide or DPP-4 inhibitors, outside of license in respective participating country

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liraglutide	liraglutide	-
DPP-4	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated haemoglobin)	Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)

Secondary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
Change in body weight	Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)