Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Japan.

Completed

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

Trial summary

Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Jardiance
Type of treatment: Pill or oral medicine
How many people: 8,145 participants
Where: 1 siteJapan
Study dates: 12 Jun 2015to 4 Dec 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 3,000 Japanese patients with the assessment of 3-year completed administration

Who may be able to join

Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Multiple Locations

Other trials in Japan

About this study

Official title: Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients With Type 2 Diabetes Mellitus

Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2
Being tested: Jardiance
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.

JardianceDrug
Empagliflozin

Study groups in NCT02489942
Study group	Role	What they receive
Jardiance		Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg Receives: Drug: Jardiance

What is being measured

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

Number of Patients With Adverse Drug Reactions (ADRs)
Number of patients with adverse drug reactions.
Measured: From first drug administration until 7 days after last drug administration, up to 247 weeks.

Secondary outcomes (2)

Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period
Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period.
Measured: At start of treatment and at last observation on treatment, up to 246 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period
Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period.
Measured: At start of treatment and at last observation on treatment, up to 246 weeks.

Timeline

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

12 Jun 20154 Dec 2020

First posted3 Jul 2015 (estimated)
Study start12 Jun 2015
Primary completion11 Nov 2020
Study completion4 Dec 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.
Publications (1)Papers the sponsor has linked to this study.
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: 8,145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02489942
Sponsor's protocol ID: 1245.94
Status last verified: Dec 2021
First submitted: 21 May 2015
Last updated: 4 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

Publications

Kaku K, Chin R, Naito Y, Iliev H, Ikeda R, Ochiai K, Yasui A. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study. Expert Opin Drug Saf. 2020 Feb;19(2):211-221. doi: 10.1080/14740338.2020.1694659. Epub 2019 Nov 26.
PubMed 31769309

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 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02489942
Acronym / sponsor ID: 1245.94
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 8,145 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 12 Jun 2015 (actual)
Primary completion: 11 Nov 2020 (actual)
Study completion: 4 Dec 2020 (actual)
First posted: 3 Jul 2015 (estimated)
Results: Posted 4 Feb 2022

Clinical summary

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

Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus

Study design

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

Arm	Type	Receives
Jardiance	–	Drug: JardiancePatients with T2DM to receive Jardiance tablets 10 mg, 25 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 3,000 Japanese patients with the assessment of 3-year completed administration

Key inclusion criteria (1 listed)

Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment

Key exclusion criteria (1 listed)

None

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
JardianceEmpagliflozin	Drug	Jardiance

Primary outcome

Number of Patients With Adverse Drug Reactions (ADRs)
Time frame: From first drug administration until 7 days after last drug administration, up to 247 weeks.
Number of patients with adverse drug reactions.

2 secondary outcomes

Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period
Time frame: At start of treatment and at last observation on treatment, up to 246 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period
Time frame: At start of treatment and at last observation on treatment, up to 246 weeks.

Results and safety

Results posted to the registry on 4 Feb 2022, 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® User 10 Milligram (mg) or 25 mg	8,145	4,729

Primary outcome: Number of Patients With Adverse Drug Reactions (ADRs)

Time frame: From first drug administration until 7 days after last drug administration, up to 247 weeks.. Count of participants. Unit: Participants

Measure	JARDIANCE® User 10 Milligram (mg) or 25 mg n = 7947
Value	1029

Population analysed: Safety Set: All patients who had received treatment of JARDIANCE® tablet at least one time except those who were found to have no observation after enrollment, invalid registration, or invalid contract with the site.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 7 days after last drug administration, up to 247 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
JARDIANCE® User 10 Milligram (mg) or 25 mg	381 of 7,947 (4.8%)	0 of 7,947 (0%)	42 of 7,947

Limitations and caveats (from the sponsor): Since this surveillance was an observational, non interventional study, it lacked the methodological rigour of a randomised control trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31769309Kaku K, Chin R, Naito Y, Iliev H, Ikeda R, Ochiai K, Yasui A. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study. Expert Opin Drug Saf. 2020 Feb;19(2):211-221. doi: 10.1080/14740338.2020.1694659. Epub 2019 Nov 26.
Related InfoLink provided by the sponsor.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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 Japan.

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 1 inclusion and 1 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 4 Feb 2022. 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 Japan. 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 4 Feb 2022). 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?

Number of Patients With Adverse Drug Reactions (ADRs) (time frame: From first drug administration until 7 days after last drug administration, up to 247 weeks.). 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 NCT02489942, which also lists 1 linked publication.

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 4 Feb 2022.