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

NCT ID: NCT02773355

Last Updated: 2022-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-16

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Saxenda®

liraglutide 3.0 mg

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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 the 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Novo Nordisk Investigational Site

México, State of Mexico, Mexico

Site Status

Novo Nordisk Investigational Site

Puebla City, , Mexico

Site Status

Countries

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Mexico

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1170-6497

Identifier Type: OTHER

Identifier Source: secondary_id

NN8022-4210

Identifier Type: -

Identifier Source: org_study_id

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