Clinical trial NCT03642717: Regulatory Request NIS in Korea
Official title: A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of JARDIANCE DUO® (Empagliflozin/Metformin, 5/500mg, 5/850mg, 5/1000mg, 12.5/500mg, 12.5/850mg, 12.5/1000mg) in Korean Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 658
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is an observational prospective, non-interventional, open-label, multi-centre national study. It will provide additional safety information of JARDIANCE DUO® (empagliflozin/metformin) in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting

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


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 \< 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

Primary outcomes:
measure: Percentage of Participants With Any Adverse Events
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
measure: Percentage of Participants With Adverse Events Relating to Study Drug
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
measure: Percentage of Participants With Unexpected Adverse Events
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
measure: Percentage of Participants With Adverse Events of Special Interest
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
measure: Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Secondary outcomes:
measure: Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline
timeFrame: 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).
measure: Number of Participants Reached Target Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit
timeFrame: At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).
measure: Number of Participants With Relative Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c Decrease of 0.5% Comparing to Baseline) at Last Visit
timeFrame: 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).
measure: Change in the Fasting Plasma Glucose (FPG) at Last Visit From Baseline
timeFrame: 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).
measure: Change in the Body Weight at Last Visit From Baseline
timeFrame: 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).
measure: Change in the Systolic Blood Pressure (SBP) at Last Visit From Baseline
timeFrame: 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).
measure: Change in the Diastolic Blood Pressure (DBP) at Last Visit From Baseline
timeFrame: 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).
measure: Number of Participants Per Final Effectiveness Assessment Category at Last Visit
timeFrame: At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Bucheon
country: Korea, Republic of
facility: Hyewon Medical Foundation Sejong Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Hongik Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
Study officials:
affiliation: jane.lee.ext@boehringer-ingelheim.com
name: Jane(JiEun) Lee, 8227090092
role: STUDY_CHAIR
References: