Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea

AstraZeneca

Status: Completed

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Exenatide

Study type: Observational

Funder types: Industry

Identifiers

NCT02090673

MB001-078

Details and patient eligibility

About

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.

Enrollment: 1,711 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Male or female at least 18 years of age
• Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
• Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information

Exclusion Criteria:

• Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
• Are pregnant or have intentions of becoming pregnant within the duration of the study
• Contraindications

Trial design

1,711 participants in 1 patient group

Group1:Type 2 diabetic patients treated with Exenatide therapy

Description:

Korean patients who are at least 18 years old, diagnosed with type 2 diabetes, and are treated with Exenatide in an ambulatory care setting according to the approved label

Treatment:

Drug: Exenatide