Korean Post-marketing Surveillance for Onglyza®

AstraZeneca

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: No Intervention (subjects were previously treated with Onglyza®)

Study type: Observational

Funder types: Industry

Identifiers

NCT01575483

CV181-171

Details and patient eligibility

About

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Onglyza® so that the regulatory authority can manage the marketing approval properly.

Enrollment: 3,433 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male patients who are at least 18 years of age
• Patients with diagnosis of T2DM initiating Onglyza® treatment within the approved indications in Korea

Exclusion criteria

• Indication which is not approved for Onglyza® in Korea
• Patients with contraindication for the use of Onglyza® (as clarified in Korean label)

Trial design

3,433 participants in 1 patient group

Patients with T2DM

Description:

Patients with diagnosis of type 2 diabetes mellitus (T2DM) initiating Onglyza® treatment within the approved indications will be enrolled

Treatment:

Drug: No Intervention (subjects were previously treated with Onglyza®)