Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"

An observational study of Type 2 Diabetes Mellitus, run by Takeda 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

The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting. Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Trelagliptin
Type of treatment: Pill or oral medicine
How many people: 89 participants
Where: 1 siteJapan
Study dates: 1 Mar 2020to 31 Jan 2023
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 complicated by severe renal impairment or end-stage renal failure as part of routine medical care.

Who may be able to join

1. Participants must be type 2 diabetes mellitus patients meeting the following conditions: Have severe renal impairment or end-stage renal disease, with serum creatinine (mg/dL) or creatinine clearance (Ccr; mL/min) meeting the following criteria within 3 months before the start of treatment with this product
Serum creatinine (mg/dL)*: male: > 2.4, female: > 2.0
Ccr (mL/min): < 30 In patients with end-stage renal disease, this product may be administered irrespective of the time of hemodialysis.
Estimated values corresponding to the Ccr (for persons aged 60 years weighing 65 kg)

Who cannot join

1. Participants with any of the following contraindications for trelagliptin will be excluded:
Patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus
Patient with severe infection, perioperative status, or serious trauma
Patient with a history of hypersensitivity to any ingredients of trelagliptin

Trial locations and contacts

1 site in 1 country.

Japan1 site

Takeda Selected Site
Tokyo

Other trials in Japan

About this study

Official title: Specified Drug Use Surveillance on Zafatek Tablets 25 mg -Surveillance on Long-Term Use of Trelagliptin Tablets in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-Stage Renal Failure-

Read the detailed description

The drug being tested in this study is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure.

This study is an observational (non-interventional) study and will look at the long-term safety of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 100.

This multi-center observational trial will be conducted in Japan.

Conditions: Type 2 Diabetes Mellitus
Being tested: Trelagliptin
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.

TrelagliptinDrug
Also called Zafatek tablets
Trelagliptin tablets

Study groups in NCT04285983
Study group	Role	What they receive
Trelagliptin 25 mg		Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care. Receives: Drug: Trelagliptin

What is being measured

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

Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Measured: Up to Month 12
Number of Participants Who Had One or More Serious ADRs
AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Measured: Up to Month 12
Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs
Number of participants who had one or more hypoglycemia of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Measured: Up to Month 12
Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs
Number of participants who had one or more infection of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Measured: Up to Month 12

Timeline

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

1 Mar 202031 Jan 2023

First posted26 Feb 2020
Study start1 Mar 2020
Primary completion31 Jan 2023
Study completion31 Jan 2023

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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by TakedaThe 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: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04285983
Sponsor's protocol ID: Trelagliptin-4004
Other IDs: jRCT1080225091
Status last verified: Mar 2024
First submitted: 24 Feb 2020
Last updated: 23 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data 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 Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Specified Drug Use Surveillance on Zafatek Tablets 25 mg -Surveillance on Long-Term Use of Trelagliptin Tablets in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-Stage Renal Failure-
ClinicalTrials.gov ID: NCT04285983
Acronym / sponsor ID: Trelagliptin-4004
Conditions: Type 2 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 1 Mar 2020 (actual)
Primary completion: 31 Jan 2023 (actual)
Study completion: 31 Jan 2023 (actual)
First posted: 26 Feb 2020 (actual)
Results: Posted 23 Aug 2024

Clinical summary

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

Detailed description

This multi-center observational trial will be conducted in Japan.

Study design

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

Arm	Type	Receives
Trelagliptin 25 mg	–	Drug: TrelagliptinTrelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure as part of routine medical care.

Key inclusion criteria (4 listed)

1. Participants must be type 2 diabetes mellitus patients meeting the following conditions: Have severe renal impairment or end-stage renal disease, with serum creatinine (mg/dL) or creatinine clearance (Ccr; mL/min) meeting the following criteria within 3 months before the start of treatment with this product
Serum creatinine (mg/dL)*: male: > 2.4, female: > 2.0
Ccr (mL/min): < 30 In patients with end-stage renal disease, this product may be administered irrespective of the time of hemodialysis.

Key exclusion criteria (4 listed)

1. Participants with any of the following contraindications for trelagliptin will be excluded:
Patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus
Patient with severe infection, perioperative status, or serious trauma
Patient with a history of hypersensitivity to any ingredients of trelagliptin

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
TrelagliptinAlso: Zafatek tabletsTrelagliptin tablets	Drug	Trelagliptin 25 mg

Primary outcome

Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
Time frame: Up to Month 12
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Number of Participants Who Had One or More Serious ADRs
Time frame: Up to Month 12
AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs
Time frame: Up to Month 12
Number of participants who had one or more hypoglycemia of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs
Time frame: Up to Month 12
Number of participants who had one or more infection of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.

Results and safety

Results posted to the registry on 23 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trelagliptin 25 mg	89	83

Primary outcome: Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)

Time frame: Up to Month 12. Count of participants. Unit: Participants

Measure	Trelagliptin 25 mg n = 83
Value	6

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants Who Had One or More Serious ADRs

Time frame: Up to Month 12. Count of participants. Unit: Participants

Measure	Trelagliptin 25 mg n = 83
Value	2

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs

Time frame: Up to Month 12. Count of participants. Unit: Participants

Measure	Trelagliptin 25 mg n = 83
Serious ADRs	0
Other ADRs	1

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs

Time frame: Up to Month 12. Count of participants. Unit: Participants

Measure	Trelagliptin 25 mg n = 83
Serious ADRs	0
Other ADRs	0

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Adverse events

Time frame: Up to Month 12. Other adverse events reported at 2.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trelagliptin 25 mg	33 of 83 (39.8%)	10 of 83 (12%)	5 of 83

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data 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.

Study Director study director

Takeda

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 Type 2 Diabetes Mellitus, run by Takeda 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 4 inclusion and 4 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 Aug 2024. 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 Aug 2024). 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 Who Had One or More Adverse Drug Reactions (ADRs) (time frame: Up to Month 12). The study lists 4 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 NCT04285983.

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 Aug 2024.