Observational Study on Efficacy and Safety of Liraglutide in Subjects With Type 2 Diabetes (EVIDENCE)

February 10, 2017 updated by: Novo Nordisk A/S

Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes

This observational study is conducted in Europe. The aim of this non-interventional (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the conditions of use of Victoza® in daily medical practice in France.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3152

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

  • France
      • Paris La défense cedex, France, 92932
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients starting or having recently started liraglutide treatment for less than one week, and satisfying the study inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Patients diagnosed with type 2 diabetes
  • Patients having recently started (for less than one week) or starting liraglutide (Victoza®) treatment

Exclusion Criteria:

  • Hypersensitivity (allergy) to liraglutide or to any of the excipients
  • Patient is participating in a clinical trial at the inclusion
  • Type 1 diabetes

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
Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0%
Time Frame: Month 24
Month 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c at month 3
Time Frame: Month 0, Month 3
Month 0, Month 3
Change in HbA1c at month 6
Time Frame: Month 0, Month 6
Month 0, Month 6
Change in HbA1c at month 12
Time Frame: Month 0, Month 12
Month 0, Month 12
Change in HbA1c at month 18
Time Frame: Month 0, Month 18
Month 0, Month 18
Change in HbA1c at month 24
Time Frame: Month 0, Month 24
Month 0, Month 24
Change in fasting plasma glucose (FPG) at month 3
Time Frame: Month 0, Month 3
Month 0, Month 3
Change in fasting plasma glucose (FPG) at month 6
Time Frame: Month 0, Month 6
Month 0, Month 6
Change in fasting plasma glucose (FPG) at month 12
Time Frame: Month 0, Month 12
Month 0, Month 12
Change in fasting plasma glucose (FPG) at month 18
Time Frame: Month 0, Month 18
Month 0, Month 18
Change in fasting plasma glucose (FPG) at month 24
Time Frame: Month 0, Month 24
Month 0, Month 24
Change in Body Weight at Month 3
Time Frame: Month 0, Month 3
Month 0, Month 3
Change in Body Weight at Month 6
Time Frame: Month 0, Month 6
Month 0, Month 6
Change in Body Weight at Month 12
Time Frame: Month 0, Month 12
Month 0, Month 12
Change in Body Weight at Month 18
Time Frame: Month 0, Month 18
Month 0, Month 18
Change in Body Weight at Month 24
Time Frame: Month 0, Month 24
Month 0, Month 24

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Medical Advisor, 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

September 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-3815
  • U1111-1116-2722 (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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on liraglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe