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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 26, 2014