A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes

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 objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care. Read more about this study

Who is it for?: Any age
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: TRADIANCE® Combination Tablets AP and TRADIANCE® Combination Tablets BP
Type of treatment: Pill or oral medicine
How many people: 1,164 participants
Where: 1 siteJapan
Study dates: 15 Jan 2019to 27 Apr 2021
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with type 2 Diabetes Mellitus

Who may be able to join

Japanese patients with Type 2 Diabetes mellitus (T2DM) who are prescribed with TRADIANCE® Combination Tablets AP or BP
Patients who have never been treated with TRADIANCE® Combination Tablets AP or BP before enrolment

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nippon Boehringer Ingelheim Co., Ltd
Tokyo, 1416017

Other trials in Japan

About this study

Official title: Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients With Type 2 Diabetes Mellitus

Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.

Conditions: Diabetes Mellitus, Type 2
Being tested: TRADIANCE® Combination Tablets AP, TRADIANCE® Combination Tablets BP
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.

TRADIANCE® Combination Tablets APDrug
Fixed dose combination
TRADIANCE® Combination Tablets BPDrug
Fixed dose combination

Study groups in NCT03761797
Study group	Role	What they receive
Subjects with type 2 Diabetes Mellitus		Not described Receives: Drug: TRADIANCE® Combination Tablets AP; Drug: TRADIANCE® Combination Tablets BP

What is being measured

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

Number of Participants With Adverse Drug Reactions (ADRs)
The number of participants with adverse drug reactions is reported.
Measured: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.

Timeline

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

15 Jan 201927 Apr 2021

First posted3 Dec 2018
Study start15 Jan 2019
Primary completion10 Mar 2021
Study completion27 Apr 2021

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: 1,164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03761797
Sponsor's protocol ID: 1275-0026
Status last verified: Apr 2022
First submitted: 30 Nov 2018
Last updated: 23 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial\_results/ clinical\_submission\_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Publications

Inagaki N, Nishimoto T, Nishiya Y, Nitta D. Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination therapy in Japanese patients with type 2 diabetes: final results of a one-year post-marketing surveillance study. Expert Opin Drug Saf. 2023 Feb;22(2):153-163. doi: 10.1080/14740338.2022.2107200. Epub 2022 Aug 16.
PubMed 35946927

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 23 Jan 2023. 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 TRADIANCE® Combination Tablets AP and BP in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT03761797
Acronym / sponsor ID: 1275-0026
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 1,164 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 15 Jan 2019 (actual)
Primary completion: 10 Mar 2021 (actual)
Study completion: 27 Apr 2021 (actual)
First posted: 3 Dec 2018 (actual)
Results: Posted 23 Jan 2023

Clinical summary

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

Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.

Study design

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

Arm	Type	Receives
Subjects with type 2 Diabetes Mellitus	–	Drug: TRADIANCE® Combination Tablets AP, Drug: TRADIANCE® Combination Tablets BP

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with type 2 Diabetes Mellitus

Key inclusion criteria (2 listed)

Japanese patients with Type 2 Diabetes mellitus (T2DM) who are prescribed with TRADIANCE® Combination Tablets AP or BP
Patients who have never been treated with TRADIANCE® Combination Tablets AP or BP before 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
TRADIANCE® Combination Tablets APFixed dose combination	Drug	Subjects with type 2 Diabetes Mellitus
TRADIANCE® Combination Tablets BPFixed dose combination	Drug	Subjects with type 2 Diabetes Mellitus

Primary outcome

Number of Participants With Adverse Drug Reactions (ADRs)
Time frame: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
The number of participants with adverse drug reactions is reported.

Results and safety

Results posted to the registry on 23 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients With Type 2 Diabetes Mellitus	1,164	1,025

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

Time frame: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.. Count of participants. Unit: Participants

Measure	All Patients With Type 2 Diabetes Mellitus n = 1146
Value	32

Population analysed: Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.

Adverse events

Time frame: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients With Type 2 Diabetes Mellitus	40 of 1,146 (3.5%)	0 of 1,146 (0%)	5 of 1,146

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35946927Inagaki N, Nishimoto T, Nishiya Y, Nitta D. Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination therapy in Japanese patients with type 2 diabetes: final results of a one-year post-marketing surveillance study. Expert Opin Drug Saf. 2023 Feb;22(2):153-163. doi: 10.1080/14740338.2022.2107200. Epub 2022 Aug 16.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

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Not yet recruitingObservational study
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Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus

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.

Rie Ikeda, 81364172200 study chair

zzCDMJP_PV_PMS@boehringer-ingelheim.com

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 2 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 23 Jan 2023. 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 23 Jan 2023). 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 Participants With Adverse Drug Reactions (ADRs) (time frame: From first dose of study medication until last dose + 7 days, up to 102.1 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 NCT03761797, 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 23 Jan 2023.