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Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes

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: NCT01403025
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).

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

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Study Type : Observational
Actual Enrollment : 4121 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : July 19, 2011
Actual Primary Completion Date : December 28, 2015
Actual Study Completion Date : December 28, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Group/Cohort Intervention/treatment
Liraglutide Drug: liraglutide
Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm




Primary Outcome Measures :
  1. The incidence of SADRs (Serious Adverse Drug Reactions) [ Time Frame: After 36 months ]

Secondary Outcome Measures :
  1. The incidence rate and type of SAEs (Serious Adverse Events) [ Time Frame: At month 1, 3, 6, 12, 24 and 36 ]
  2. The incidence rate and type of ADRs (Adverse Drug Reactions) [ Time Frame: At month 1, 3, 6, 12, 24 and 36 ]


Information from the National Library of Medicine

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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
Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who are considered to need treatment with liraglutide (Victoza®)
Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide

Exclusion Criteria:

  • Subjects who are or have previously been on liraglutide
  • Subjects who have previously been enrolled in the study
  • Subjects with a hypersensitivity to liraglutide or to any of the excipients
  • Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
  • Subjects with cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial
  • Known or suspected abuse of alcohol or narcotics

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): NCT01403025


Locations
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Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01403025    
Other Study ID Numbers: NN2211-3772
U1111-1120-7575 ( Other Identifier: WHO )
JapicCTI-111559 ( Registry Identifier: JAPIC )
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 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