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NCT01890993 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01890993
Other study ID # NN2211-4077
Secondary ID U1111-1142-2764E
Status Completed
Phase N/A
First received June 27, 2013
Last updated May 20, 2015
Start date August 2013
Est. completion date June 2014

Study information
Verified date May 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority France: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesSpain: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 952
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• liraglutide
Anonymised patient level data will be collected by the patients' own general practitioner and electronic case report form (eCRF) will be used to capture the data.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

France,  Germany,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c (glycosylated haemoglobin) Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2) No
Secondary Change in body weight Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2) No
Secondary Change in systolic blood pressure Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2) No
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