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

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ClinicalTrials.gov Identifier: NCT01226966
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide

Study Type : Observational
Actual Enrollment : 3152 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : September 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Group/Cohort Intervention/treatment
A Drug: liraglutide
Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.




Primary Outcome Measures :
  1. Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0% [ Time Frame: Month 24 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients starting or having recently started liraglutide treatment for less than one week, and satisfying the study inclusion and exclusion criteria.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226966


Locations
France
Novo Nordisk Investigational Site
Paris La défense cedex, France, 92932
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452), Medical Advisor Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01226966     History of Changes
Other Study ID Numbers: NN2211-3815
U1111-1116-2722 ( Other Identifier: WHO )
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists