Diabetes Mellitus, Type 2
Conditions
Brief summary
To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting
Interventions
DRUGJARDIANCE 10mg
T2DM with JARDIANCE 10mg
DRUGJARDIANCE 25mg
MT2DM with JARDIANCE 25mgax
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 110 Years
Healthy volunteers
No
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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any Adverse Events | 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 any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. |
| Percentage of Participants With Adverse Events Relating to Study Drug | 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 was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. |
| Percentage of Participants With Unexpected Adverse Events | 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 was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. |
| Percentage of Participants With Adverse Events of Special Interest | 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 (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 |
| Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug | 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 was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit | 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 Glycosylated Hemoglobin (HbA1c) at Last Visit | 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 glycosylated hemoglobin (HbA1c) at last visit. |
| Number of Participants Per Final Effectiveness Assessment Category at Last Visit | 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 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.). |
| Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit | 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. |
| Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit | 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 With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit | 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 with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit | 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 Body Weight at Last Visit | 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. |
Countries
South Korea
Participant flow
Recruitment details
This was and observational prospective, non-interventional, open-label, multi-centre study to monitor the safety profile and efficacy of JARDIANCE® (empagliflozin, 10 milligram (mg), 25mg) in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| JARDIANCE® JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day. | 3,231 |
| Total | 3,231 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | follow-up failure | 6 |
| Overall Study | have not taken the study drug | 11 |
| Overall Study | Protocol Violation | 119 |
| Overall Study | subject who are duplicated | 1 |
Baseline characteristics
| Characteristic | JARDIANCE® | — |
|---|---|---|
| Age, Continuous | 56.66 years STANDARD_DEVIATION 11.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1380 Participants | — |
| Sex: Female, Male Male | 1851 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3,231 |
| other Total, other adverse events | 0 / 3,231 |
| serious Total, serious adverse events | 55 / 3,231 |
Outcome results
Primary
Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug
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.
Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JARDIANCE® | Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug | 3.25 Percentage of participants |
Primary
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.
Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JARDIANCE® | Percentage of Participants With Adverse Events of Special Interest | 1.45 Percentage of participants |
Primary
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.
Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JARDIANCE® | Percentage of Participants With Adverse Events Relating to Study Drug | 5.14 Percentage of participants |
Primary
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.
Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JARDIANCE® | Percentage of Participants With Any Adverse Events | 13.93 Percentage of participants |
Primary
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.
Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JARDIANCE® | Percentage of Participants With Unexpected Adverse Events | 11.54 Percentage of participants |
Secondary
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).
Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JARDIANCE® | Change From Baseline in Body Weight at Last Visit | -1.91 kilogram | Standard Deviation 3.37 |
p-value: <0.0001paired t-test
Secondary
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).
Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JARDIANCE® | Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit | -1.80 millimeters of mercury (mmHg) | Standard Deviation 10.82 |
p-value: <0.0001paired t-test
Secondary
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).
Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JARDIANCE® | Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit | -25.59 milligram per deciliter (mg/dl) | Standard Deviation 59.84 |
p-value: <0.0001paired t-test
Secondary
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).
Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JARDIANCE® | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit | -0.68 Percentage of glycosylated hemoglobin | Standard Deviation 1.39 |
p-value: <0.0001paired t-test
Secondary
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).
Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JARDIANCE® | Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit | -3.95 millimeters of mercury (mmHg) | Standard Deviation 15.44 |
p-value: <0.0001paired t-test
Secondary
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).
Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JARDIANCE® | Number of Participants Per Final Effectiveness Assessment Category at Last Visit | Improved | 1749 Participants |
| JARDIANCE® | Number of Participants Per Final Effectiveness Assessment Category at Last Visit | Unchanged | 546 Participants |
| JARDIANCE® | Number of Participants Per Final Effectiveness Assessment Category at Last Visit | Aggravated | 195 Participants |
| JARDIANCE® | Number of Participants Per Final Effectiveness Assessment Category at Last Visit | Unassessable | 77 Participants |
Secondary
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).
Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JARDIANCE® | Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit | lower than 7% | 1132 Participants |
| JARDIANCE® | Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit | greater than or equal to 7% | 1435 Participants |
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
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).
Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JARDIANCE® | Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit | greater than or equal to 0.5% | 1315 Participants |
| JARDIANCE® | Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit | lower than 0.5% | 1252 Participants |