Completed

Liraglutide (Victoza®) Safety Profile in Korean Type 2 Diabetes Mellitus Patients

Study Aim

This observational study aims to evaluate the safety of Liraglutide (Victoza®) by observing the incidence of serious adverse drug reactions in Korean patients with Type 2 Diabetes Mellitus.

What is being collected

Drug Data

Collected from today forward - Prospective

Drug

Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: November 2013

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: August 21, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: November 20, 2013

Actual date on which the first participant was enrolled.

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.

NCT01821846

Principal SponsorNovo Nordisk A/S

Last updated: August 21, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

2 inclusion criteria required to participate

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

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

4 exclusion criteria prevent from participating

Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods

Subjects with a hypersensitivity to Victoza or to any of the excipients

Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)

Subjects with personal or family history of medullary thyroid carcinoma (MTC)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Novo Nordisk Investigational Site

Pyungchon-Dong 896, Dongan-Gu, South KoreaOpen Novo Nordisk Investigational Site in Google Maps

Novo Nordisk Investigational Site

Seoul, South Korea

Novo Nordisk Investigational Site

Seoul, South Korea

Novo Nordisk Investigational Site

Seoul, South Korea

Completed7 Study Centers