Type 2 Diabetes Mellitus Who Have Been Examined at a Medical InstitutionNCT01945216

Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

An observational study of Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution, 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.

Official record

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Trial summary

The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution
What is being tested?: Alogliptin
Type of treatment: Pill or oral medicine
How many people: 3,317 participants
Where: 1 siteJapan
Study dates: 8 Jul 2010to 31 Oct 2015
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 who have been examined at a medical institution

Who may be able to join

Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:
Diet therapy and exercise therapy alone
In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor

Who cannot join

Patients contraindicated for Nesina
Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.)
Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.)
Patients with a history of hypersensitivity to any ingredient of Nesina

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Osaka

Other trials in Japan

About this study

In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.

Read the detailed description

A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions.

Participants of this surveillance will be patients with type 2 diabetes mellitus who failed to respond adequately to diet therapy and exercise therapy alone or to a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. The planned sample size is 3,000 subjects.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily. Participants will receive the drug as part of routine medical care.

Conditions: Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution
Being tested: Alogliptin
Keywords: Drug therapy

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 NCT01945216
Study group	Role	What they receive
Alogliptin 25mg, tablets, orally, once daily, up to 36 months		Not described Receives: Drug: Alogliptin

What is being measured

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

Number of Participants Who Experience at Least One 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 month 36 relative to baseline.
Measured: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)

Secondary outcomes (1)

Change From Baseline in Fasting Blood Glucose
The change in the value of fasting blood glucose collected at month 36 relative to baseline.
Measured: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (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.

8 Jul 201031 Oct 2015

First posted18 Sep 2013 (estimated)
Study start8 Jul 2010
Primary completion31 Oct 2015
Study completion31 Oct 2015

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 Mellitus Who Have Been Examined at a Medical InstitutionStudies 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: 3,317 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01945216
Sponsor's protocol ID: 121-011
Other IDs: JapicCTI-132250, JapicCTI-R171018
Status last verified: Nov 2019
First submitted: 13 Sep 2013
Last updated: 19 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.

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
ClinicalTrials.gov ID: NCT01945216
Acronym / sponsor ID: 121-011
Conditions: Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution
Keywords: Drug therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 3,317 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 8 Jul 2010 (actual)
Primary completion: 31 Oct 2015 (actual)
Study completion: 31 Oct 2015 (actual)
First posted: 18 Sep 2013 (estimated)
Results: Posted 8 Nov 2018

Clinical summary

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

Detailed description

A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily. Participants will receive the drug as part of routine medical care.

Study design

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

Arm	Type	Receives
Alogliptin 25mg, tablets, orally, once daily, up to 36 months	–	Drug: Alogliptin

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with type 2 diabetes mellitus who have been examined at a medical institution

Key inclusion criteria (3 listed)

Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:

Key exclusion criteria (4 listed)

Patients contraindicated for Nesina

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 25mg, tablets, orally, once daily, up to 36 months

Primary outcome

Number of Participants Who Experience at Least One Adverse Events
Time frame: Up to Month 36
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (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 month 36 relative to baseline.

1 secondary outcome

Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)

Results and safety

Results posted to the registry on 8 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Population	3,317	3,218

Primary outcome: Number of Participants Who Experience at Least One Adverse Events

Time frame: Up to Month 36. Count of participants. Unit: Participants

Measure	Alogliptin n = 1560	Alogliptin + α-GI n = 669	Alogliptin + Other n = 989
Value	151	98	139

Population analysed: Safety Analysis Set was defined as all participants who were enrolled and completed the study.

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

Time frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36). Mean (Standard Deviation). Unit: Percent

Measure	Alogliptin n = 1341	Alogliptin + α-GI n = 612
Change at Month 1	-0.45 (0.581)	-0.33 (0.708)
Change at Month 3	-0.79 (1.007)	-0.54 (1.074)
Change at Month 6	-0.84 (1.045)	-0.70 (1.128)
Change at Month 12	-0.83 (1.102)	-0.75 (1.054)
Change at Month 18	-0.81 (1.077)	-0.62 (1.190)
Change at Month 24	-0.82 (1.095)	-0.66 (1.214)
Change at Month 30	-0.83 (1.114)	-0.73 (1.271)
Change at Month 36	-0.84 (1.131)	-0.72 (1.318)

Population analysed: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. Reported group were Alogliptin and Alogliptin + α-GI and data for Alogliptin + Other were not collected as specified in protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Month 36. Other adverse events reported at 0.4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alogliptin	2 of 1,560 (0.1%)	26 of 1,560 (1.7%)	1 of 1,560
Alogliptin + αGI	2 of 669 (0.3%)	19 of 669 (2.8%)	1 of 669
Alogliptin + Other	8 of 989 (0.8%)	23 of 989 (2.3%)	2 of 989

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 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.

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 Who Have Been Examined at a Medical Institution, 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 3 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 19 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 8 Nov 2018). 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 Experience at Least One 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 NCT01945216.

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 19 Nov 2019.