Diabetes Mellitus, Type 2NCT01904383

PMS of Trazenta on the Long-term Use as Add-on Therapy

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 Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus. Read more about this study

Who is it for?: Any age
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Trazenta
Type of treatment: Pill or oral medicine
How many people: 4,057 participants
Where: 1 siteJapan
Study dates: 1 Jul 2013to 4 Oct 2018
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: 3000 patients with type 2 Diabetes Mellitus

Who may be able to join

Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.

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 on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus

Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.

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

TrazentaDrug
1 tablet of 5 mg Trazenta tablets once daily

Study groups in NCT01904383
Study group	Role	What they receive
Trazenta		Not described Receives: Drug: Trazenta

What is being measured

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

Percentage of Participants With Drug Related Adverse Events
Percentage of participants with drug related adverse events.
Measured: From first drug administration until last drug administration, up to approximately 156 weeks.

Secondary outcomes (1)

The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c)
The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c).
Measured: Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks.

Timeline

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

1 Jul 20134 Oct 2018

First posted22 Jul 2013 (estimated)
Study start1 Jul 2013
Primary completion4 Oct 2018
Study completion4 Oct 2018

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: 4,057 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01904383
Sponsor's protocol ID: 1218.147
Status last verified: Sep 2019
First submitted: 8 Jul 2013
Last updated: 2 Oct 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Ito T, Naito Y, Shimmoto N, Ochiai K, Hayashi N, Okamura T. Long-term safety and effectiveness of linagliptin as add-on therapy in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance. Expert Opin Drug Saf. 2021 Mar;20(3):363-372. doi: 10.1080/14740338.2021.1859477. Epub 2020 Dec 27.
PubMed 33269625

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 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01904383
Acronym / sponsor ID: 1218.147
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 4,057 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 1 Jul 2013 (actual)
Primary completion: 4 Oct 2018 (actual)
Study completion: 4 Oct 2018 (actual)
First posted: 22 Jul 2013 (estimated)
Results: Posted 2 Oct 2019

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 Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.

Study design

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

Arm	Type	Receives
Trazenta	–	Drug: Trazenta

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 3000 patients with type 2 Diabetes Mellitus

Key inclusion criteria (1 listed)

Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.

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
Trazenta1 tablet of 5 mg Trazenta tablets once daily	Drug	Trazenta

Primary outcome

Percentage of Participants With Drug Related Adverse Events
Time frame: From first drug administration until last drug administration, up to approximately 156 weeks.
Percentage of participants with drug related adverse events.

1 secondary outcome

The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c)
Time frame: Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks.

Results and safety

Results posted to the registry on 2 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trazenta®	4,057	2,283

Primary outcome: Percentage of Participants With Drug Related Adverse Events

Time frame: From first drug administration until last drug administration, up to approximately 156 weeks.. Number. Unit: Percentage (%) of participants

Measure	Trazenta® n = 3372
Value	11.39

Population analysed: Safety set: This patient set included all patients who were dispensed Trazenta® Tablets as add-on therapy, and had at least 1 observation after treatment. The patients treated with Trazenta® Tablets as monotherapy were not included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trazenta®	304 of 3,372 (9%)	184 of 3,372 (5.5%)	74 of 3,372

Limitations and caveats (from the sponsor): The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33269625Ito T, Naito Y, Shimmoto N, Ochiai K, Hayashi N, Okamura T. Long-term safety and effectiveness of linagliptin as add-on therapy in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance. Expert Opin Drug Saf. 2021 Mar;20(3):363-372. doi: 10.1080/14740338.2021.1859477. Epub 2020 Dec 27.
Related InfoLink provided by the sponsor.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
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Active, not recruiting
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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
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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 2 Oct 2019. 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 2 Oct 2019). 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 Drug Related Adverse Events (time frame: From first drug administration until last drug administration, up to approximately 156 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 NCT01904383, 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 2 Oct 2019.