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Completed

NCT Number: NCT01403025

Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).

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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

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide

Exclusion criteria

  • Subjects who are or have previously been on liraglutide
  • Subjects who have previously been enrolled in the study
  • Subjects with a hypersensitivity to liraglutide 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 cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial
  • Known or suspected abuse of alcohol or narcotics

Treatment and study plan

liraglutide

Drug

Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm

Primary outcomes

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

    Time frame: After 36 months

Secondary outcomes

  1. The incidence rate and type of SAEs (Serious Adverse Events)

    Time frame: At month 1, 3, 6, 12, 24 and 36

  2. The incidence rate and type of ADRs (Adverse Drug Reactions)

    Time frame: At month 1, 3, 6, 12, 24 and 36

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2011
Registry last updated
Feb 12, 2018

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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