Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice

April 16, 2018 updated by: Novo Nordisk A/S
This study is conducted in Europe. The aim of this study is to investigate Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1788

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00144
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive subjects initiating liraglutide in 2011 according to Victoza® SmPC meeting the inclusion criteria will be enrolled.

Description

Inclusion Criteria:

  • Subjects of age above 18 years as per Victoza® SmPC par.4.2 and 5.1 diagnosed with type 2 diabetes receiving the first prescription of liraglutide in 2011

Exclusion Criteria:

  • None. Available data from all eligible patients for each center, will be included

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: liraglutide
No treatment given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of patients achieving HbA1c reduction of at least 1%-point
Time Frame: Week 0, week 52
Week 0, week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c (Glycosylated haemoglobin))
Time Frame: Week 0, week 104
Week 0, week 104
Change in body weight
Time Frame: Week 0, week 104
Week 0, week 104
Frequency of patients achieving HbA1c reduction of at least 1%-point
Time Frame: After 4 and 24 months of treatment
After 4 and 24 months of treatment
Frequency of patients achieving HbA1c target (<=7%)
Time Frame: After 4, 12 and 24 months
After 4, 12 and 24 months
Frequency of patients achieving a body weight reduction of at least 3%
Time Frame: After 4, 12 and 24 months
After 4, 12 and 24 months
Frequency of patients achieving the composite endpoint consisting in: HbA1c reduction of at least 1%-point and body weight reduction of at least 3%
Time Frame: After 4, 12 and 24 months
After 4, 12 and 24 months
Percentage of treatment discontinuation for any reason
Time Frame: At 4, 12 and 24 months
At 4, 12 and 24 months
Changes in blood pressure and lipid profile
Time Frame: Week 0, week 104
Week 0, week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2015

Primary Completion (Actual)

November 16, 2015

Study Completion (Actual)

November 16, 2015

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-4118
  • U1111-1143-9842 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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