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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Chichibu, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

No treatment given.

Primary outcomes

Number of AEs (adverse events)

Time frame: Week 0-52

Secondary outcomes

Number of adverse reactions (ARs)

Time frame: Week 0-52
Change in HbA1c (glycosylated haemoglobin)

Time frame: Week 0, week 52

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Dec 22, 2014
Registry last updated: Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed