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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01226966
First received: October 20, 2010
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0% [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c at month 3 [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
  • Change in HbA1c at month 6 [ Time Frame: Month 0, Month 6 ] [ Designated as safety issue: No ]
  • Change in HbA1c at month 12 [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • Change in HbA1c at month 18 [ Time Frame: Month 0, Month 18 ] [ Designated as safety issue: No ]
  • Change in HbA1c at month 24 [ Time Frame: Month 0, Month 24 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) at month 3 [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) at month 6 [ Time Frame: Month 0, Month 6 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) at month 12 [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) at month 18 [ Time Frame: Month 0, Month 18 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) at month 24 [ Time Frame: Month 0, Month 24 ] [ Designated as safety issue: No ]
  • Change in Body Weight at Month 3 [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
  • Change in Body Weight at Month 6 [ Time Frame: Month 0, Month 6 ] [ Designated as safety issue: No ]
  • Change in Body Weight at Month 12 [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • Change in Body Weight at Month 18 [ Time Frame: Month 0, Month 18 ] [ Designated as safety issue: No ]
  • Change in Body Weight at Month 24 [ Time Frame: Month 0, Month 24 ] [ Designated as safety issue: No ]

Enrollment: 3152
Study Start Date: October 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: liraglutide
Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226966

Locations
France
Paris La défense cedex, France, 92932
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Hind Moumane, Medical Advisor Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01226966     History of Changes
Other Study ID Numbers: NN2211-3815, U1111-1116-2722
Study First Received: October 20, 2010
Last Updated: February 27, 2014
Health Authority: France: Not required for observational study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014