Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus

August 18, 2017 updated by: Novo Nordisk A/S

A 6-month, Multi-centre, Open Labelled, Non-randomized, Non-interventional, Safety Study of Liraglutide (Victoza®) in Subjects With Type 2 Diabetes Mellitus in Korea

This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

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

  • Korea, Republic of
      • Pyungchon-Dong 896, Dongan-Gu, Korea, Republic of, 431-796
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 02447
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 03080
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 150-950
        • Novo Nordisk Investigational Site
      • Ulsan, Korea, Republic of, 682-060
        • Novo Nordisk Investigational Site
      • Ulsan, Korea, Republic of, 44455
        • Novo Nordisk Investigational Site
      • Wonju, Korea, Republic of, 220-701
        • 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

Victoza® will be prescribed and titrated by the physician.

Description

Inclusion Criteria:

  • Subjects with T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician
  • Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information

Exclusion Criteria:

  • Subjects with a hypersensitivity to Victoza® or to any of the excipients
  • Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
  • Subjects with personal or family history of medullary thyroid carcinoma (MTC)
  • Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)

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
Administered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of SADRs (Serious Adverse Drug Reactions)
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c (Glycosylated haemoglobin) change
Time Frame: Month 0, month 6
Month 0, month 6
Percentage of subjects reaching the target of HbA1c below 7.0%
Time Frame: Month 6
Month 6
Change in body weight
Time Frame: Month 0, month 6
Month 0, month 6
Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions)
Time Frame: Up to 6 months
Up to 6 months

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)

November 20, 2013

Primary Completion (Actual)

March 8, 2017

Study Completion (Actual)

March 8, 2017

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 29, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-3929
  • U1111-1132-2221 (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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