To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting
Study Type
OBSERVATIONAL
Enrollment
3,368
T2DM with JARDIANCE 10mg
MT2DM with JARDIANCE 25mgax
Unnamed facility
Multiple Locations, South Korea
Percentage of Participants With Any Adverse Events
Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of Participants With Adverse Events Relating to Study Drug
Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of Participants With Unexpected Adverse Events
Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of Participants With Adverse Events of Special Interest
Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. The following are considered as AESIs: * Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection * Increased urination * Urinary tract infection (UTI) * Volume depletion * Diabetic Ketoacidosis (DKA) * Decreased renal function: * Hepatic injury * Lower limb amputation
Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug
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Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit
Change from baseline in glycosylated hemoglobin (HbA1c) at last visit.
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit
Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.
Time frame: At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit
Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit
Change from baseline in fasting plasma glucose (FPG) at last visit.
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Body Weight at Last Visit
Change from baseline in body weight at last visit.
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit
Change from baseline in systolic blood pressure (SBP) at last visit.
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit
Change from baseline in diastolic blood pressure (DBP) at last visit.
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Number of participants per final effectiveness assessment category at last visit was reported. The final effeciveness consisted of 4 categories: Improved (If determined as there was any effect of maintaining or improving disease related factors.), Unchanged (If disease related factors had not been changed compared with before administration, and not determined as there was any effect of maintaining symptoms.), Aggravated (If disease related factors were worse than before administration.), and Unassessable (If it cannot be determined due to insufficient information collected.).
Time frame: At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).