Regulatory Request NIS in Korea

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642717
• Other study ID #: 1276-0039
• Status: Completed
• Start date: August 21, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: April 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 658
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• JARDIANCE DUO®
empagliflozin and metformin

Locations

Country	Name	City	State
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	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
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	Inje University Sanggye Paik Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	SoonChunHyang University Seoul Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 event was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
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 event was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
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 event was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Primary	Percentage of Participants With Adverse Events of Special Interest	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.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
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 event was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Secondary	Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline	Change in the glycosylated hemoglobin (HbA1c) at Last Visit from baseline was reported.	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).
Secondary	Number of Participants Reached Target Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit	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%.	At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).
Secondary	Number of Participants With Relative Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c Decrease of 0.5% Comparing to Baseline) at Last Visit	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.	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).
Secondary	Change in the Fasting Plasma Glucose (FPG) at Last Visit From Baseline	Change in the Fasting Plasma Glucose (FPG) at Last Visit from baseline was reported.	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).
Secondary	Change in the Body Weight at Last Visit From Baseline	Change in the body weight at Last Visit from baseline was reported.	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).
Secondary	Change in the Systolic Blood Pressure (SBP) at Last Visit From Baseline	Change in the systolic blood pressure (SBP) at Last Visit from baseline was reported.	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).
Secondary	Change in the Diastolic Blood Pressure (DBP) at Last Visit From Baseline	Change in the diastolic blood pressure (DBP) at Last Visit from baseline was reported.	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).
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 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.).	At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

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