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Completed

NCT Number: NCT01821846

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

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.

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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, Pyungchon-Dong 896, Dongan-Gu, South Korea

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Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

liraglutide

Drug

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).

Primary outcomes

  1. The incidence of SADRs (Serious Adverse Drug Reactions)

    Time frame: Up to 6 months

Secondary outcomes

  1. HbA1c (Glycosylated haemoglobin) change

    Time frame: Month 0, month 6

  2. Percentage of subjects reaching the target of HbA1c below 7.0%

    Time frame: Month 6

  3. Change in body weight

    Time frame: Month 0, month 6

  4. Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions)

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2013
Registry last updated
Aug 21, 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.

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