N/A
Completed N=3,368
JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02848833 ↗Enrolled (actual)
3,368
Serious AEs
1.7%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants With Any Adverse Events — 13.93 Percentage of participants
Summary
To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Any Adverse Events |
13.93 | — |
| PRIMARY Percentage of Participants With Adverse Events Relating to Study Drug |
5.14 | — |
| PRIMARY Percentage of Participants With Unexpected Adverse Events |
11.54 | — |
| PRIMARY Percentage of Participants With Adverse Events of Special Interest |
1.45 | — |
| PRIMARY Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug |
3.25 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit |
-0.68 | <0.0001 sig |
| SECONDARY Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit |
1132; 1435 | — |
| SECONDARY Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit |
1315; 1252 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit |
-25.59 | <0.0001 sig |
| SECONDARY Change From Baseline in Body Weight at Last Visit |
-1.91 | <0.0001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit |
-3.95 | <0.0001 sig |
| SECONDARY Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit |
-1.80 | <0.0001 sig |
| SECONDARY Number of Participants Per Final Effectiveness Assessment Category at Last Visit |
1749; 546; 195; 77 | — |
Eligibility Criteria
Inclusion criteria
- Patients who have been started on JARDIANCE® 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
- Known hypersensitivity to empagliflozin or any of its excipients
- Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
- Patients with persistent estimated Glomerular Filtration Rate <60 mL/min/1.73 m2,end stage renal disease or on dialysis
- Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®
Data sourced from ClinicalTrials.gov (NCT02848833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.