Korean Post-marketing Surveillance for Onglyza®

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No Intervention (subjects were previously treated with Onglyza®)

Drug

No Intervention

Other names: saxagliptin

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

Time frame: 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

Time frame: Baseline (Week 0), 12 weeks and 24 weeks of registration

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Apr 11, 2012
Registry last updated: Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed