N/A
Completed N=658
Regulatory Request NIS in Korea
Source: ClinicalTrials.gov NCT03642717 ↗Enrolled (actual)
658
Serious AEs
1.6%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants With Any Adverse Events — 11.94 Percentage of participants
Summary
To monitor the safety profile and effectiveness of JARDIANCE DUO® in Korean 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 |
11.94 | — |
| PRIMARY Percentage of Participants With Adverse Events Relating to Study Drug |
5.48 | — |
| PRIMARY Percentage of Participants With Unexpected Adverse Events |
9.03 | — |
| PRIMARY Percentage of Participants With Adverse Events of Special Interest |
0.65 | — |
| PRIMARY Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug |
2.90 | — |
| SECONDARY Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline |
-0.72 | < 0.0001 sig |
| SECONDARY Number of Participants Reached Target Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit |
239; 258 | — |
| SECONDARY Number of Participants With Relative Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c Decrease of 0.5% Comparing to Baseline) at Last Visit |
242; 255 | — |
| SECONDARY Change in the Fasting Plasma Glucose (FPG) at Last Visit From Baseline |
-26.86 | < 0.0001 sig |
| SECONDARY Change in the Body Weight at Last Visit From Baseline |
-2.18 | < 0.0001 sig |
| SECONDARY Change in the Systolic Blood Pressure (SBP) at Last Visit From Baseline |
-1.96 | 0.0076 sig |
| SECONDARY Change in the Diastolic Blood Pressure (DBP) at Last Visit From Baseline |
-2.04 | < 0.0001 sig |
| SECONDARY Number of Participants Per Final Effectiveness Assessment Category at Last Visit |
330; 103; 45; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have started at first time on JARDIANCE DUO® 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 JARDIANCE®, JARDIANCE DUO®
- Hypersensitivity to active ingredients empagliflozin and/or metformin or to any of the excipients
- Moderate (stage 3b) and severe renal failure (CrCl 60ml/min/1.73m2, JARDIANCE DUO® must be discontinued prior to, or at the time of the test and not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further. In patients with moderate renal impairment (eGFR 45-60 ml/min/1.73m2), JARDIANCE DUO® must be discontinued 48 hours before administration of iodinated contrast media and not be reinstituted until at least 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further.
- In patients with severe infections or severe traumatic systemic disorders, JARDIANCE DUO® should be temporarily suspended, and should not be restarted until the patient's oral intake has resumed and renal function has been evaluated as normal.
- JARDIANCE DUO® should be temporarily suspended for any surgical procedure(except minor procedures not associated with restricted intake of food and fluids)before 48 hours, and not be reinstituted until 48 hours afterwards, after renal function has been evaluated as normal.
- Patients with malnutrition, starvation, hypostheniam pituitary or adrenal insufficiency
- Impaired hepatic function (since impaired hepatic function has been associated with some cases of lactic acidosis, JARDIANCE DUO® should generally be avoided in patients with clinical or laboratory evidence of hepatic disease), pulmonary infarction, severe respiratory impairment, any condition associated with hypoxemia, excessive alcohol intake, GI disorders such as dehydration, diarrhoea or vomiting
- Pregnant women, women who may be pregnant, nursing women
- Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock
- Current participation in other clinical trials
Data sourced from ClinicalTrials.gov (NCT03642717). 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.