Regulatory Request NIS in Korea

NCT03642717 | Completed Results FDA Drug

• 1 other identifier: 1276-0039
• Study Type: observational
• Target: 658
• Locations: 1 country
• Sites: 20

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (8)

• 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).

• 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 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).

• 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 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).

Study Arms (1)

Subjects diagnosed with type 2 diabetes mellitus

Drug: JARDIANCE DUO®

Interventions

JARDIANCE DUO® DRUG

empagliflozin and metformin

Subjects diagnosed with type 2 diabetes mellitus

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (20)

Korea University Ansan Hospital

Ansan, 15355, South Korea

Location

Hyewon Medical Foundation Sejong Hospital

Bucheon-si, 14754, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 41931, South Korea

Location

Eulji University Hospital

Daejeon, 35233, South Korea

Location

Myongji Hospital

Goyang, 10475, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, 01757, South Korea

Location

Seoul Medical Center

Seoul, 02053, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

SoonChunHyang University Seoul Hospital

Seoul, 04404, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Hongik Hospital

Seoul, 07937, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Jane(JiEun) Lee, 8227090092

  jane.lee.ext@boehringer-ingelheim.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 22, 2018
• Study Start: August 21, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: May 21, 2021
• Results First Posted: May 21, 2021

Record last verified: 2021-04

Locations

KR (20)