Overview

JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2020-04-17
Target enrollment:
0
Participant gender:
All
Summary
To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Empagliflozin
Criteria
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®