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Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255266
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This study is conducted in Europe. The aim of this study is to investigate Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.

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

Study Design
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Study Type : Observational
Actual Enrollment : 1788 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice
Actual Study Start Date : March 26, 2015
Actual Primary Completion Date : November 16, 2015
Actual Study Completion Date : November 16, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Groups and Cohorts
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Group/Cohort Intervention/treatment
A Drug: liraglutide
No treatment given.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of patients achieving HbA1c reduction of at least 1%-point [ Time Frame: Week 0, week 52 ]

Secondary Outcome Measures :
  1. Change in HbA1c (Glycosylated haemoglobin)) [ Time Frame: Week 0, week 104 ]
  2. Change in body weight [ Time Frame: Week 0, week 104 ]
  3. Frequency of patients achieving HbA1c reduction of at least 1%-point [ Time Frame: After 4 and 24 months of treatment ]
  4. Frequency of patients achieving HbA1c target (<=7%) [ Time Frame: After 4, 12 and 24 months ]
  5. Frequency of patients achieving a body weight reduction of at least 3% [ Time Frame: After 4, 12 and 24 months ]
  6. Frequency of patients achieving the composite endpoint consisting in: HbA1c reduction of at least 1%-point and body weight reduction of at least 3% [ Time Frame: After 4, 12 and 24 months ]
  7. Percentage of treatment discontinuation for any reason [ Time Frame: At 4, 12 and 24 months ]
  8. Changes in blood pressure and lipid profile [ Time Frame: Week 0, week 104 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive subjects initiating liraglutide in 2011 according to Victoza® SmPC meeting the inclusion criteria will be enrolled.
Criteria

Inclusion Criteria:

  • Subjects of age above 18 years as per Victoza® SmPC par.4.2 and 5.1 diagnosed with type 2 diabetes receiving the first prescription of liraglutide in 2011

Exclusion Criteria:

  • None. Available data from all eligible patients for each center, will be included
Contacts and Locations
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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): NCT02255266


Locations
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Italy
Novo Nordisk Investigational Site
Rome, Italy, 00144
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02255266    
Other Study ID Numbers: NN2211-4118
U1111-1143-9842 ( Other Identifier: WHO )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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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