Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"

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 the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) 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?: Alogliptin and Metformin hydrochloride
Type of treatment: Pill or oral medicine
How many people: 1,026 participants
Where: 1 siteJapan
Study dates: 28 Feb 2017to 31 Oct 2019
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 for whom combination therapy with alogliptin and metformin hydrochloride is appropriate in the opinion of a physician as the routine medical care.

Who may be able to join

Participants should meet one or more of the following:
Have renal impairment (mild)
Have hepatic impairment (mild or moderate)
Elderly (aged 65 years or more)

Who cannot join

Participants with any contraindication for study drug.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Takeda Selected Site
Tokyo

Other trials in Japan

About this study

Read the detailed description

The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more).

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600.

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

Conditions: Type 2 Diabetes Mellitus
Being tested: Alogliptin and Metformin hydrochloride
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.

Alogliptin and Metformin hydrochlorideDrug
Also called Inisync combination tablets
Alogliptin and Metformin hydrochloride combination tablets

Study groups in NCT03555565
Study group	Role	What they receive
Alogliptin and Metformin hydrochloride		Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. Receives: Drug: Alogliptin and Metformin hydrochloride

What is being measured

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

Percentage 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: Up to 12 months

Secondary outcomes (3)

Change From Baseline in Glycosylated Hemoglobin (HbA1c)
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline.
Measured: Baseline, up to final assessment point (up to Month 12)
Change From Baseline in Fasting Blood Glucose
The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline.
Measured: Baseline, up to final assessment point (up to Month 12)
Change From Baseline in Fasting Insulin Level
The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.
Measured: Baseline, up to final assessment point (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.

28 Feb 201731 Oct 2019

First posted13 Jun 2018
Study start28 Feb 2017
Primary completion31 Oct 2019
Study completion31 Oct 2019

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: 1,026 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03555565
Sponsor's protocol ID: Alogliptin-Met-5003
Other IDs: JapicCTI-183979
Status last verified: Aug 2023
First submitted: 1 Jun 2018
Last updated: 13 Sep 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"
ClinicalTrials.gov ID: NCT03555565
Acronym / sponsor ID: Alogliptin-Met-5003
Conditions: Type 2 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 1,026 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 28 Feb 2017 (actual)
Primary completion: 31 Oct 2019 (actual)
Study completion: 31 Oct 2019 (actual)
First posted: 13 Jun 2018 (actual)
Results: Posted 23 Nov 2020

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
Alogliptin and Metformin hydrochloride	–	Drug: Alogliptin and Metformin hydrochlorideAlogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily 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 for whom combination therapy with alogliptin and metformin hydrochloride is appropriate in the opinion of a physician as the routine medical care.

Key inclusion criteria (4 listed)

Participants should meet one or more of the following:

Key exclusion criteria (1 listed)

Participants with any contraindication for study 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
Alogliptin and Metformin hydrochlorideAlso: Inisync combination tabletsAlogliptin and Metformin hydrochloride combination tablets	Drug	Alogliptin and Metformin hydrochloride

Primary outcome

Percentage of Participants Who Had One or More Adverse Events
Time frame: Up to 12 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.

3 secondary outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, up to final assessment point (up to Month 12)
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, up to final assessment point (up to Month 12)
Change From Baseline in Fasting Insulin Level
Time frame: Baseline, up to final assessment point (up to Month 12)

Results and safety

Results posted to the registry on 23 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alogliptin and Metformin Hydrochloride	1,026	1,011

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

Time frame: Up to 12 months. Number. Unit: Percentage of Participants

Measure	Alogliptin and Metformin Hydrochloride n = 1011
Value	5.93

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 months. Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alogliptin and Metformin Hydrochloride	4 of 1,011 (0.4%)	13 of 1,011 (1.3%)	1 of 1,011

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
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
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
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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 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 13 Sep 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 Nov 2020). 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 Who Had One or More Adverse Events (time frame: Up to 12 months). 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 NCT03555565.

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 13 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.