Type 2 Diabetes MellitusNCT01964963

Alogliptin Tablets Special Drug Use Surveillance: Mild 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 study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild 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?: Alogliptin
Type of treatment: Pill or oral medicine
How many people: 19,192 participants
Where: 1 siteJapan
Study dates: 3 Aug 2011to 31 Jul 2017
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 mild type 2 diabetes mellitus who have been examined at a medical institution

Who may be able to join

-Patients with Haemoglobin A1c (HbA1c) [Japan Diabetes Society (JDS) value] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.

Who cannot join

-Patients contraindicated for alogliptin.
Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
Patients with a history of hypersensitivity to any ingredient of alogliptin.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Tokyo

Other trials in Japan

About this study

Official title: Alogliptin (Nesina) Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Read the detailed description

This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.

Conditions: Type 2 Diabetes Mellitus
Being tested: Alogliptin
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.

AlogliptinDrug
Also called Nesina, SYR-322
Alogliptin tablets

Study groups in NCT01964963
Study group	Role	What they receive
Alogliptin		Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care. Receives: Drug: Alogliptin

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
Measured: Up to Month 36
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 36) relative to baseline.
Measured: Baseline, and final assessment point (up to Month 36)

Secondary outcomes (1)

Change From Baseline in Fasting Blood Glucose
The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline.
Measured: Baseline, and 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.

3 Aug 201131 Jul 2017

First posted17 Oct 2013 (estimated)
Study start3 Aug 2011
Primary completion31 Jul 2017
Study completion31 Jul 2017

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: 19,192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01964963
Sponsor's protocol ID: 121-015
Other IDs: JapicCTI-132283
Status last verified: Nov 2019
First submitted: 15 Oct 2013
Last updated: 21 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alogliptin (Nesina) Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01964963
Acronym / sponsor ID: 121-015
Conditions: Type 2 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 19,192 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 3 Aug 2011 (actual)
Primary completion: 31 Jul 2017 (actual)
Study completion: 31 Jul 2017 (actual)
First posted: 17 Oct 2013 (estimated)
Results: Posted 9 May 2019

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 study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Detailed description

Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.

Study design

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

Arm	Type	Receives
Alogliptin	–	Drug: AlogliptinAlogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive 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 mild type 2 diabetes mellitus who have been examined at a medical institution

Key inclusion criteria (1 listed)

-Patients with Haemoglobin A1c (HbA1c) [Japan Diabetes Society (JDS) value] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.

Key exclusion criteria (4 listed)

-Patients contraindicated for alogliptin.
Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
Patients with a history of hypersensitivity to any ingredient of alogliptin.

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
AlogliptinAlso: Nesina, SYR-322Alogliptin tablets	Drug	Alogliptin

Primary outcome

Percentage of Participants Who Had One or More Adverse Events
Time frame: Up to Month 36
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, and final assessment point (up to Month 36)
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 36) relative to baseline.

1 secondary outcome

Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, and final assessment point (up to Month 36)

Results and safety

Results posted to the registry on 9 May 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
Alogliptin 25 mg	19,192	18,249

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

Time frame: Up to Month 36. Number. Unit: Percentage of Participants

Measure	Alogliptin 25 mg n = 18249
Value	10.54

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

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline, and final assessment point (up to Month 36). Mean (Standard Deviation). Unit: Percent HbA1c

Measure	Alogliptin 25 mg n = 16022
Value	-0.14 (0.777)

Population analysed: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Month 36. Other adverse events reported at 0.2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alogliptin 25 mg	65 of 18,249 (0.4%)	41 of 18,249 (0.2%)	20 of 18,249

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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 21 Nov 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 9 May 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 Who Had One or More Adverse Events (time frame: Up to Month 36). 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 NCT01964963.

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 21 Nov 2019.