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Completed

NCT Number: NCT01226966

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

This observational study is conducted in Europe. The aim of this non-interventional (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the conditions of use of Victoza® in daily medical practice in France.

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Paris La Défense Cedex, 92932, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with type 2 diabetes
  • Patients having recently started (for less than one week) or starting liraglutide (Victoza®) treatment

Exclusion criteria

  • Hypersensitivity (allergy) to liraglutide or to any of the excipients
  • Patient is participating in a clinical trial at the inclusion
  • Type 1 diabetes

Treatment and study plan

liraglutide

Drug

Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.

Primary outcomes

  1. Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0%

    Time frame: Month 24

Secondary outcomes

  1. Change in HbA1c at month 3

    Time frame: Month 0, Month 3

  2. Change in HbA1c at month 6

    Time frame: Month 0, Month 6

  3. Change in HbA1c at month 12

    Time frame: Month 0, Month 12

  4. Change in HbA1c at month 18

    Time frame: Month 0, Month 18

  5. Change in HbA1c at month 24

    Time frame: Month 0, Month 24

  6. Change in fasting plasma glucose (FPG) at month 3

    Time frame: Month 0, Month 3

  7. Change in fasting plasma glucose (FPG) at month 6

    Time frame: Month 0, Month 6

  8. Change in fasting plasma glucose (FPG) at month 12

    Time frame: Month 0, Month 12

  9. Change in fasting plasma glucose (FPG) at month 18

    Time frame: Month 0, Month 18

  10. Change in fasting plasma glucose (FPG) at month 24

    Time frame: Month 0, Month 24

  11. Change in Body Weight at Month 3

    Time frame: Month 0, Month 3

  12. Change in Body Weight at Month 6

    Time frame: Month 0, Month 6

  13. Change in Body Weight at Month 12

    Time frame: Month 0, Month 12

  14. Change in Body Weight at Month 18

    Time frame: Month 0, Month 18

  15. Change in Body Weight at Month 24

    Time frame: Month 0, Month 24

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes

Acronym: EVIDENCE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2010
Registry last updated
Feb 13, 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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