Korean Post-marketing Surveillance for Onglyza®

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01575483

Enrollment

3433

Registered

2012-04-11

Start date

2012-03-01

Completion date

2016-09-07

Last updated

2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGNo Intervention (subjects were previously treated with Onglyza®)

No Intervention

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Adverse events occurrence	30 days after last dose of study drug

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026