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Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients

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ClinicalTrials.gov Identifier: NCT02773355
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2016
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in North America. The aim is to investigate timely detection of pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions possibly or probably related to Saxenda® in Mexican patients.

Condition or disease Intervention/treatment
Obesity Drug: liraglutide 3.0 mg

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients
Actual Study Start Date : May 16, 2016
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

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
Saxenda® Drug: liraglutide 3.0 mg
Patients will be treated with commercially available Saxenda® prescribed according to routine clinical practice at the discretion of the treating physician.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of pancreatitis [ Time Frame: Year 0-3 ]

Secondary Outcome Measures :
  1. Adverse drug reactions (ADR) [ Time Frame: Year 0-3 ]

Eligibility Criteria
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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
The medical condition investigated in this study is obesity and overweight with one or more weight related comorbidities. The study will aim at observing all patients exposed to Saxenda® during treatment by the 20 participating physicians in Mexico.
Criteria

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
  • The decision to initiate treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
  • Obese patients (BMI equal to or above 30 kg/m^2) or overweight patients (BMI Equal to or above 27 kg/m^2) with at least one weight related comorbidity according to Saxenda® label text in Mexico
  • Age equal or above 18 years at the time of signing informed consent

Exclusion Criteria:

  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Hypersensitivity to Saxenda® or to any of its excipients
  • Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
  • Diagnosis of type 1 diabetes
Contacts and Locations
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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): NCT02773355


Locations
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Mexico
Novo Nordisk Investigational Site
Mexico, Estado De México, Mexico, 52763
Novo Nordisk Investigational Site
Monterrey, Nuevo León, Mexico, 66220
Novo Nordisk Investigational Site
Puebla, Mexico, 72190
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:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02773355    
Other Study ID Numbers: NN8022-4210
U1111-1170-6497 ( Other Identifier: WHO )
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
 Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists