Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®)

August 31, 2017 updated by: Novo Nordisk A/S
This trial is conducted in Asia. The aim of this trial is to evaluate safety and effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination with antidiabetes agents other than sulfonylurea under post-marketing normal clinical practice conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1092

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

  • Japan
      • Chichibu-city, Japan, 368-0004
        • Novo Nordisk Investigational Site
      • Koriyama-shi, Fukushima, Japan, 963 8851
        • Novo Nordisk Investigational Site
      • Oyama-shi, Tochigi, Japan, 323 0022
        • Novo Nordisk Investigational Site
      • Tagajo-shi, Japan, 985 0852
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 1000005
        • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male or female patients with T2DM who the physician has decided to start on treatment with Victoza® in combination with insulin or oral anti-diabetes drug (OAD) other than SU (Sulfonylurea) will be eligible for this study.

Description

Inclusion Criteria:

  • Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
  • Patients with T2DM (type 2 diabetes mellitus) who the physician has decided to start treatment with Victoza® in combination with insulin or OAD (oral anti-diabetes drug) other than SU (sulfonylurea)
  • Male or female, no age limitation

Exclusion Criteria:

  • Previous participation in this study or NN2211-3772 Participation is defined as informed consent obtained for this study or enrolment for NN2211-3772
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Patients who are on Victoza® or have previously been on Victoza® within 3 month before the enrolment

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
Liraglutide
Drug: liraglutide

Liraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions.

No treatment given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of AEs (adverse events)
Time Frame: Week 0-52
Week 0-52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c (glycosylated haemoglobin)
Time Frame: Week 0, week 52
Week 0, week 52
Number of adverse reactions (ARs)
Time Frame: Week 0-52
Week 0-52

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.

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)

December 15, 2014

Primary Completion (ACTUAL)

June 16, 2017

Study Completion (ACTUAL)

June 16, 2017

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (ESTIMATE)

December 22, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-4175
  • U1111-1157-6701 (OTHER: 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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