JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site 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 Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting Read more about this study

Who is it for?: Ages 19 to 110 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: JARDIANCE 10mg and JARDIANCE 25mg
How many people: 3,368 participants
Where: 1 siteSouth Korea
Study dates: 10 Aug 2016to 17 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 to 110 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: type 2 diabetes mellitus in Korea

Who may be able to join

Patients who have been started on JARDIANCE® 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

Known hypersensitivity to empagliflozin or any of its excipients
Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
Patients with persistent estimated Glomerular Filtration Rate <60 mL/min/1.73 m2,end stage renal disease or on dialysis
Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Study site
Multiple Locations

Other trials in South Korea

About this study

Official title: A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of JARDIANCE® (Empagliflozin, 10mg, 25mg, q.d.) in Korean Patients With Type 2 Diabetes Mellitus

To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting

Conditions: Diabetes Mellitus, Type 2
Being tested: JARDIANCE 10mg, JARDIANCE 25mg
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 10mgDrug
T2DM with JARDIANCE 10mg
JARDIANCE 25mgDrug
MT2DM with JARDIANCE 25mgax

Study groups in NCT02848833
Study group	Role	What they receive
JARDIANCE		T2DM with JARDIANCE Receives: Drug: JARDIANCE 10mg; Drug: JARDIANCE 25mg

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 events was calculated by Exact Method.
Measured: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 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 events was calculated by Exact Method.
Measured: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 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 events was calculated by Exact Method.
Measured: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of Participants With Adverse Events of Special Interest
Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
The following are considered as AESIs:
- Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection
- Increased urination
- Urinary tract infection (UTI)
- Volume depletion
- Diabetic Ketoacidosis (DKA)
- Decreased renal function:
- Hepatic injury
- Lower limb amputation
Measured: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 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 events was calculated by Exact Method.
Measured: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Secondary outcomes (8)

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit
Change from baseline in glycosylated hemoglobin (HbA1c) at last visit.
Measured: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit
Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.
Measured: At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit
Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit
Measured: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit
Change from baseline in fasting plasma glucose (FPG) at last visit.
Measured: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Body Weight at Last Visit
Change from baseline in body weight at last visit.
Measured: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit
Change from baseline in systolic blood pressure (SBP) at last visit.
Measured: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit
Change from baseline in diastolic blood pressure (DBP) at last visit.
Measured: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
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 effeciveness 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 the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Timeline

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

10 Aug 201617 Apr 2020

First posted29 Jul 2016 (estimated)
Study start10 Aug 2016
Primary completion17 Apr 2020
Study completion17 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: Cohort
Time perspective: Prospective
Enrolment: 3,368 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02848833
Sponsor's protocol ID: 1245.116
Status last verified: Apr 2021
First submitted: 27 Jun 2016
Last updated: 11 May 2021
Results posted: Yes, on ClinicalTrials.gov

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 11 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® (Empagliflozin, 10mg, 25mg, q.d.) in Korean Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02848833
Acronym / sponsor ID: 1245.116
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 3,368 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 10 Aug 2016 (actual)
Primary completion: 17 Apr 2020 (actual)
Study completion: 17 Apr 2020 (actual)
First posted: 29 Jul 2016 (estimated)
Results: Posted 11 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 Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
JARDIANCE	–	Drug: JARDIANCE 10mg, Drug: JARDIANCE 25mgT2DM with JARDIANCE

Who may qualify

Ages: 19 to 110 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: type 2 diabetes mellitus in Korea

Key inclusion criteria (3 listed)

Patients who have been started on JARDIANCE® 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 (5 listed)

Known hypersensitivity to empagliflozin or any of its excipients
Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
Patients with persistent estimated Glomerular Filtration Rate <60 mL/min/1.73 m2,end stage renal disease or on dialysis
Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®

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 10mgT2DM with JARDIANCE 10mg	Drug	JARDIANCE
JARDIANCE 25mgMT2DM with JARDIANCE 25mgax	Drug	JARDIANCE

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 attended during the study), up to 544 days.
Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events 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 attended during the study), up to 544 days.
Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events 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 attended during the study), up to 544 days.
Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events 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 attended during the study), up to 544 days.
Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. The following are considered as AESIs: * Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection * Increased urination * Urinary tract infection (UTI) * Volume depletion * Diabetic Ketoacidosis (DKA) * Decreased renal function: * Hepatic injury * Lower limb amputation
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 attended during the study), up to 544 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 events was calculated by Exact Method.

8 secondary outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit
Time frame: At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Body Weight at Last Visit
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit
Time frame: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Time frame: At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Results and safety

Results posted to the registry on 11 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®	3,368	3,231

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 attended during the study), up to 544 days.. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	JARDIANCE® n = 3231
Value	13.93 (12.75 to 15.17)

Population analysed: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® 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® n = 3231
Value	5.14 (4.40 to 5.96)

Primary outcome: Percentage of Participants With Unexpected Adverse Events

Measure	JARDIANCE® n = 3231
Value	11.54 (10.46 to 12.70)

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

Measure	JARDIANCE® n = 3231
Value	1.45 (1.07 to 1.93)

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 attended during the study), up to 544 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
JARDIANCE®	55 of 3,231 (1.7%)	0 of 3,231 (0%)	0 of 3,231

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site 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 1 site 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 5 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 11 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 1 site 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 11 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 attended during the study), up to 544 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 NCT02848833.

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 11 May 2021.