Regulatory Request NIS in Korea

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 20 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: JARDIANCE DUO®
How many people: 658 participants
Where: 20 sitesSouth Korea
Study dates: 21 Aug 2018to 30 Apr 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

South Korea20 sites

Korea University Ansan Hospital
Ansan, 15355
Hyewon Medical Foundation Sejong Hospital
Bucheon-si, 14754
Inje University Busan Paik Hospital
Busan, 47392
Inje University Haeundae Paik Hospital
Busan, 48108
Keimyung University Dongsan Hospital
Daegu, 41931
Eulji University Hospital
Daejeon, 35233
Myongji Hospital
Goyang, 10475
Chonnam National University Hospital
Gwangju, 61469
Gachon University Gil Medical Center
Incheon, 21565
Inha University Hospital
Incheon, 22332
Seoul National University Bundang Hospital
Seongnam, 13620
Inje University Sanggye Paik Hospital
Seoul, 01757
Seoul Medical Center
Seoul, 02053
Kyung Hee University Hospital
Seoul, 02447
SoonChunHyang University Seoul Hospital
Seoul, 04404
Hanyang University Seoul Hospital
Seoul, 04763
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Hongik Hospital
Seoul, 07937
Ajou University Hospital
Suwon, 16499
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426

Other trials in South Korea

About this study

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

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
Being tested: JARDIANCE DUO®
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JARDIANCE DUO®Drug
empagliflozin and metformin

Study groups in NCT03642717
Study group	Role	What they receive
Subjects diagnosed with type 2 diabetes mellitus		Not described Receives: Drug: JARDIANCE DUO®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Change in the glycosylated hemoglobin (HbA1c) at Last Visit from baseline was reported.
Measured: 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
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%.
Measured: 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
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.
Measured: 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
Change in the Fasting Plasma Glucose (FPG) at Last Visit from baseline was reported.
Measured: 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
Change in the body weight at Last Visit from baseline was reported.
Measured: 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
Change in the systolic blood pressure (SBP) at Last Visit from baseline was reported.
Measured: 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
Change in the diastolic blood pressure (DBP) at Last Visit from baseline was reported.
Measured: 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 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.).
Measured: At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 201830 Apr 2020

First posted22 Aug 2018
Study start21 Aug 2018
Primary completion30 Apr 2020
Study completion30 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 658 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03642717
Sponsor's protocol ID: 1276-0039
Status last verified: Apr 2021
First submitted: 17 Aug 2018
Last updated: 21 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http://trials.boehringer-ingelheim.com/ to: 1. find information in order to request access to clinical study data, for listed studies. 2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03642717
Acronym / sponsor ID: 1276-0039
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 658 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 21 Aug 2018 (actual)
Primary completion: 30 Apr 2020 (actual)
Study completion: 30 Apr 2020 (actual)
First posted: 22 Aug 2018 (actual)
Results: Posted 21 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To monitor the safety profile and effectiveness of JARDIANCE DUO® in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Subjects diagnosed with type 2 diabetes mellitus	–	Drug: JARDIANCE DUO®

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (3 listed)

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

Key exclusion criteria (16 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JARDIANCE DUO®empagliflozin and metformin	Drug	Subjects diagnosed with type 2 diabetes mellitus

Primary outcome

Percentage of Participants With Any Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

8 secondary outcomes

Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Per Final Effectiveness Assessment Category at Last Visit
Time frame: At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

Results and safety

Results posted to the registry on 21 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
JARDIANCE DUO® (Empagliflozin/Metformin)	658	620

Primary outcome: Percentage of Participants With Any Adverse Events

Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	JARDIANCE DUO® (Empagliflozin/Metformin) n = 620
Value	11.94 (9.49 to 14.75)

Population analysed: Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.

Primary outcome: Percentage of Participants With Adverse Events Relating to Study Drug

Measure	JARDIANCE DUO® (Empagliflozin/Metformin) n = 620
Value	5.48 (3.83 to 7.58)

Primary outcome: Percentage of Participants With Unexpected Adverse Events

Measure	JARDIANCE DUO® (Empagliflozin/Metformin) n = 620
Value	9.03 (6.89 to 11.57)

Primary outcome: Percentage of Participants With Adverse Events of Special Interest

Measure	JARDIANCE DUO® (Empagliflozin/Metformin) n = 620
Value	0.65 (0.18 to 1.64)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
JARDIANCE DUO® (Empagliflozin/Metformin)	10 of 620 (1.6%)	0 of 620 (0%)	0 of 620

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http://trials.boehringer-ingelheim.com/ to: 1. find information in order to request access to clinical study data, for listed studies. 2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jane(JiEun) Lee, 8227090092 study chair

jane.lee.ext@boehringer-ingelheim.com

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 20 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Any Adverse Events (time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03642717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.