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Completed

NCT Number: NCT01345734

Non-Interventional Study on Safety of Liraglutide in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to investigate the safety profile of liraglutide under normal conditions of use.

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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

Manila, 1605, Philippines

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 or those already receiving other anti-diabetic medications including GLP-1 analogues other than Liraglutide, who require treatment with liraglutide according to the clinical judgment of their treating physician
  • Subjects who are capable of giving study-specific signed informed consent before any collection of information

Exclusion criteria

  • Subjects with type 1 diabetes
  • Subjects who are or have previously been on liraglutide
  • Subjects who are participating in another clinical trial
  • Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
  • Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months

Treatment and study plan

liraglutide

Drug

Liraglutide will be prescribed and titrated by the treating physician and will be self-administered by the subject s.c. (under the skin) once daily. Study participants being treated with GLP-1 (Glucagon-Like Peptide 1)agonists or DDP-4-inhibitors (Dipeptidyl-peptidase 4 ) should stop treatment when initiating liraglutide treatment.

Primary outcomes

  1. Incidence of serious adverse drug reactions (SADRs)

    Time frame: Week 0, week 26

Secondary outcomes

  1. Incidence of adverse drug reactions (ADRs)

    Time frame: Week 0, week 26

  2. Incidence of serious adverse events (SAEs)

    Time frame: Week 0, week 26

  3. Frequency of hypoglycaemic episodes

    Time frame: Week 0, week 26

  4. Change in HbA1c (glycosylated haemoglobin)"

    Time frame: Week 0, week 26

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Liraglutide Effectiveness and Safety Data From Routine Clinical Practice in Philippines Study. A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes Mellitus in Philippines

Acronym: Lead-Ph

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 2, 2011
Registry last updated
Dec 11, 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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