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Completed

NCT Number: NCT01288326

Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes

The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.

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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

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs)

Exclusion criteria

  • Previously treated with liraglutide
  • Hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
  • Pregnant, breast feeding or have the intention of becoming pregnant

Treatment and study plan

liraglutide

Drug

Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.

Primary outcomes

  1. Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1%

    Time frame: month 12

  2. Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1%

    Time frame: month 12

Secondary outcomes

  1. HbA1c

    Time frame: month 12

  2. Fasting blood glucose (FBG)

    Time frame: month 12

  3. Incidence of serious adverse events (SAEs)

    Time frame: months 0-12

  4. Incidence of adverse drug reactions (ADRs)

    Time frame: months 0-12

  5. Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar)

    Time frame: months 0-12

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes Mellitus

Acronym: ROOTS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 2, 2011
Registry last updated
Jan 26, 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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