Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"

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 survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus 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: 3,198 participants
Where: 1 siteJapan
Study dates: 1 May 2016to 31 Oct 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 in the routine clinical setting

Who may be able to join

Type 2 diabetes mellitus patients

Who cannot join

Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
Have severe infection, perioperative status, or serious trauma
Have severe renal impairment or on dialysis due to end-stage renal disease
Have a history of hypersensitivity to any ingredients of this drug

Trial locations and contacts

1 site in 1 country.

Japan1 site

Takeda Selected Site
Tokyo

Other trials in Japan

About this study

The purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

Read the detailed description

The drug being tested in this survey is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 3000.

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 NCT03555591
Study group	Role	What they receive
Trelagliptin 100 mg		Trelagliptin 100 mg tablet, orally, once weekly for up to 36 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 Events
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.
Measured: 36 months
Number of Participants Who Had One or More Adverse Drug Reactions
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: 36 months

Secondary outcomes (8)

Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
The reported data was the change in the mean value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.
Measured: Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Fasting Blood Glucose
The reported data was the change in the mean value of fasting blood glucose collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.
Measured: Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Fasting Insulin Level
The reported data was the change in the mean value of fasting insulin level collected between baseline and timepoints (up to final assessment point: Month 36).
Measured: Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
The reported data was the change in the mean value of HOMA-beta. HOMA-beta measures as following; HOMA-beta = fasting insulin (microU/mL) ×360/ [fasting glucose (mg/dL) - 63].
Measured: Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Fasting Glucagon
The reported data was the change in the mean value of fasting glucagon collected between baseline and timepoints (up to final assessment point: Month 36).
Measured: Baseline, up to final assessment point (up to Month 36)
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 8.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).
Measured: Baseline, up to final assessment point (up to Month 36)
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 7.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).
Measured: Baseline, up to final assessment point (up to Month 36)
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 6.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).
Measured: Baseline, up to final assessment point (up to Month 36)

Timeline

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

1 May 201631 Oct 2021

First posted13 Jun 2018
Study start1 May 2016
Primary completion31 Oct 2021
Study completion31 Oct 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.
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: 3,198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03555591
Sponsor's protocol ID: Trelagliptin-5001
Other IDs: JapicCTI-183980
Status last verified: Dec 2023
First submitted: 1 Jun 2018
Last updated: 12 Dec 2023
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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"
ClinicalTrials.gov ID: NCT03555591
Acronym / sponsor ID: Trelagliptin-5001
Conditions: Type 2 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 3,198 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 1 May 2016 (actual)
Primary completion: 31 Oct 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 13 Jun 2018 (actual)
Results: Posted 1 Sep 2023

Clinical summary

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

The purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

Detailed description

The drug being tested in this survey is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus.

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 100 mg	–	Drug: TrelagliptinTrelagliptin 100 mg tablet, orally, once weekly for up to 36 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 in the routine clinical setting

Key inclusion criteria (1 listed)

Type 2 diabetes mellitus patients

Key exclusion criteria (4 listed)

Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
Have severe infection, perioperative status, or serious trauma
Have severe renal impairment or on dialysis due to end-stage renal disease
Have a history of hypersensitivity to any ingredients of this drug

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 100 mg

Primary outcome

Number of Participants Who Had One or More Adverse Events
Time frame: 36 months
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.
Number of Participants Who Had One or More Adverse Drug Reactions
Time frame: 36 months
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.

8 secondary outcomes

Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Fasting Insulin Level
Time frame: Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Time frame: Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Fasting Glucagon
Time frame: Baseline, up to final assessment point (up to Month 36)
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Time frame: Baseline, up to final assessment point (up to Month 36)
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Time frame: Baseline, up to final assessment point (up to Month 36)
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Time frame: Baseline, up to final assessment point (up to Month 36)

Results and safety

Results posted to the registry on 1 Sep 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
Trelagliptin 100 mg	3,198	3,121

Primary outcome: Number of Participants Who Had One or More Adverse Events

Time frame: 36 months. Count of participants. Unit: Participants

Measure	Trelagliptin 100 mg n = 3121
Value	390

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 Adverse Drug Reactions

Time frame: 36 months. Count of participants. Unit: Participants

Measure	Trelagliptin 100 mg n = 3121
Value	96

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

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trelagliptin 100 mg	167 of 3,121 (5.4%)	54 of 3,121 (1.7%)	24 of 3,121

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
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Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
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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 1 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 12 Dec 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 1 Sep 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 Who Had One or More Adverse Events (time frame: 36 months). The study lists 2 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 NCT03555591.

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 12 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.