Regulatory Request NIS in Korea
- Registration Number
- NCT03642717
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 658
- 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
- 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 < 45 ml/min or eGFR < 45 ml/min/1.73 square meter)
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, sepsis
- Type1 diabetes, acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, history of a ketoacidosis (type 1 diabetes and diabetic ketoacidosis should be treated with insulin).
- Congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure
- Radiologic studies involving the use of intravascular iodinated contrast materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials)
- Intravascular administration of iodinated contrast media may lead to acute renal failure and has been associated with lactic acidosis in patients receiving metformin.
Therefore, in patients with eGFR > 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects diagnosed with type 2 diabetes mellitus JARDIANCE DUO® -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Any Adverse Events From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days. Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse event 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 received during the study), up to 349 days. Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse event 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 received during the study), up to 349 days. Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse event 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 received during the study), up to 349 days. Percentage of participants with adverse events of special interest was reported. The 95% Confidence Interval for the percentage of participants with adverse event was calculated by Exact Method.
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 received during the study), up to 349 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 event was calculated by Exact Method.
- Secondary Outcome Measures
Name Time Method Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline). Change in the glycosylated hemoglobin (HbA1c) at Last Visit from baseline was reported.
Number of Participants Reached Target Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline). Number of participants reached target effectiveness response in the glycosylated hemoglobin (HbA1c) (HbA1c \< 7%) at Last Visit was reported. Target effectiveness response in the glycosylated hemoglobin (HbA1c) was defined as HbA1c less than 7%.
Number of Participants With Relative Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c Decrease of 0.5% Comparing to Baseline) at Last Visit At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline). Number of participants with relative effectiveness response in the glycosylated hemoglobin (HbA1c) at Last Visit was reported. Relative effectiveness response in the glycosylated hemoglobin (HbA1c) at last visit was defined as HbA1c decrease of 0.5% or more at the last visit comparing to baseline.
Change in the Fasting Plasma Glucose (FPG) at Last Visit From Baseline At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline). Change in the Fasting Plasma Glucose (FPG) at Last Visit from baseline was reported.
Change in the Body Weight at Last Visit From Baseline At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline). Change in the body weight at Last Visit from baseline was reported.
Change in the Systolic Blood Pressure (SBP) at Last Visit From Baseline At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline). Change in the systolic blood pressure (SBP) at Last Visit from baseline was reported.
Change in the Diastolic Blood Pressure (DBP) at Last Visit From Baseline At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline). Change in the diastolic blood pressure (DBP) at Last Visit from baseline was reported.
Number of Participants Per Final Effectiveness Assessment Category at Last Visit At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline). Number of participants per final effectiveness assessment category at Last Visit was reported. The final effectiveness 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.).
Trial Locations
- Locations (20)
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Hyewon Medical Foundation Sejong Hospital
🇰🇷Bucheon, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of
Myongji Hospital
🇰🇷Goyang, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
SoonChunHyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Hongik Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Seoul Medical Center
🇰🇷Seoul, Korea, Republic of