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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773355
• Other study ID #: NN8022-4210
• Secondary ID: U1111-1170-6497
• Status: Completed
• Start date: May 16, 2016
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 28, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Mexico	Novo Nordisk Investigational Site	Mexico	Estado De México
Mexico	Novo Nordisk Investigational Site	Monterrey	Nuevo León
Mexico	Novo Nordisk Investigational Site	Puebla

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of pancreatitis		Year 0-3
Secondary	Adverse drug reactions (ADR)		Year 0-3

External Links

•   Clinical Trials at Novo Nordisk