Korean Post-marketing Surveillance for Onglyza®

• Status: Completed
• Trial end date: 2016-09-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Saxagliptin

Criteria

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)