Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Empagliflozin/Linagliptin

Study type: Observational

Funder types: Industry

Identifiers

NCT05130463

1275-0028

Details and patient eligibility

About

The objectives of this study are to monitor the safety and effectiveness of Esgliteo in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.

Enrollment: 1,053 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have started at first time on Esgliteo in accordance with the approved label in Korea
• Age ≥19 years at enrolment
• Patients who have signed on the data release consent form

Exclusion criteria

• Patients with previous exposure to Esgliteo
• Patients with hypersensitivity to the empagliflozin and/or linagliptin or any of the excipients
• Patients with type 1 diabetes or diabetic ketoacidosis
• Patients with estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73m2, end stage renal disease, or patient on dialysis
• Patients for whom empagliflozin/linagliptin is contraindicated according to the local label of Esgliteo

Trial design

1,053 participants in 1 patient group

Patients diagnosed with type 2 diabetes mellitus

Description:

Patients aged 19 years or older, diagnosed with type 2 diabetes mellitus in Korea, who initiated treatment with ESGLITEO® for the first time in accordance with the locally approved label.

Treatment:

Drug: Empagliflozin/Linagliptin