JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

Boehringer Ingelheim

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: JARDIANCE 25mg; Drug: JARDIANCE 10mg

Study type: Observational

Funder types: Industry

Identifiers

NCT02848833

1245.116

Details and patient eligibility

About

To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting

Enrollment: 3,368 patients

Sex: All

Ages: 19 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who have been started on JARDIANCE® in accordance with the approved label in Korea
2. Age = 19 years at enrolment
3. Patients who have signed on the data release consent form

Exclusion criteria

1. Known hypersensitivity to empagliflozin or any of its excipients
2. Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
3. Patients with persistent estimated Glomerular Filtration Rate <60 mL/min/1.73 m2,end stage renal disease or on dialysis
4. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
5. Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®

Trial design

3,368 participants in 1 patient group

JARDIANCE

Description:

T2DM with JARDIANCE

Treatment:

Drug: JARDIANCE 25mg

Drug: JARDIANCE 10mg