Korean Post-marketing Surveillance for Onglyza®

AstraZeneca1 site in 1 country3,433 target enrollmentMarch 1, 2012

ConditionsDiabetes Mellitus, Type 2

InterventionsNo Intervention (subjects were previously treated with Onglyza®)

DrugsNo Intervention (subjects were previously treated with Onglyza®)

Overview

Phase: Not Applicable
Intervention: No Intervention (subjects were previously treated with Onglyza®)
Conditions: Diabetes Mellitus, Type 2
Sponsor: AstraZeneca
Enrollment: 3433
Locations: 1
Primary Endpoint: Adverse events occurrence
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 1, 2012

End Date

September 7, 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility 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)

Arms & Interventions

Patients with T2DM

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

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

Outcomes

Primary Outcomes

Adverse events occurrence

Time Frame: 30 days after last dose of study drug

Secondary Outcomes

Number of Adverse Events and Serious Adverse Events(30 days after last dose of study drug)
Effectiveness of Onglyza® measured by Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and 2-hr post-prandial glucose (2-hr PPG) comparing baseline data(Baseline (Week 0), 12 weeks and 24 weeks of registration)