Alogliptin Tablets Specified Drug-use Survey "Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)"

An observational study of Type 2 Diabetes Mellitus, run by Takeda at 2 sites 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 safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)* in addition to dietary/exercise therapy. 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: 964 participants
Where: 2 sitesJapan
Study dates: 30 Jun 2014to 30 Jun 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: Type 2 diabetes mellitus

Who may be able to join

-Type 2 diabetic patients meeting the following criteria are included in this survey:
Patients who have had an inadequate response to the following medications/therapies:
Use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin secretagogues, excluding other types of hypoglycemic agents (e.g., α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)*, in addition to dietary/exercise therapy
For use of alogliptin tablets in combination with these agents, a specified drug-use survey is currently ongoing.

Who cannot join

-Type 2 diabetic patients who meet any of the following criteria are excluded from this survey: Patients with contraindications for alogliptin tablets
Those with severe ketosis, in a state of diabetic coma or precoma, or with type 1 diabetes mellitus [Quickly rectifying hyperglycemia with administration of intravenous fluid or insulin is essential in these patients; therefore, administration of alogliptin tablets is not appropriate.]
Those with severe infections, before or after surgery, or with serious trauma [Controlling blood glucose with an injection of insulin is desirable for these patients; therefore, administration of alogliptin tablets is not appropriate.]
Those with a history of hypersensitivity to any of the ingredients of alogliptin tablets

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Study site
Osaka
Study site
Tokyo

Other trials in Japan

About this study

Official title: Alogliptin (Nesina) Tablets Specified Drug-use Survey "Type 2 Diabetes Mellitus: Combination Therapy With Hypoglycemic Drug (Insulin Preparation or Rapid-acting Insulin Secretagogues, Etc)"

Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.

Read the detailed description

This survey was designed to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues) in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care.

For adults, 25 mg of alogliptin is usually administered orally once daily.

Conditions: Type 2 Diabetes Mellitus
Being tested: Alogliptin
Keywords: Pharmacological therapy
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 Tablets
Alogliptin tablets

Study groups in NCT02221284
Study group	Role	What they receive
Alogliptin		Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in 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 Reactions
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are 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.
Measured: Up to Month 12

Secondary outcomes (6)

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, and final assessment point (up to Month 12)
Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)
The reported data were number of participants who achieved specified HbA1c Level (< 7.0% and <6.0%) during this study.
Measured: Baseline, and final assessment point (up to Month 12)
Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)
The reported data were change from baseline in fasting blood glucose level.
Measured: Baseline, and final assessment point (up to Month 12)
Change From Baseline in Laboratory Test Values (Fasting Insulin Level)
The reported data were change from baseline in fasting insulin level.
Measured: Baseline, and final assessment point (up to Month 12)
Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])
The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.
Measured: Baseline, and final assessment point (up to Month 12)
Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])
The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.
Measured: Baseline, and 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.

30 Jun 201430 Jun 2017

First posted20 Aug 2014 (estimated)
Study start30 Jun 2014
Primary completion30 Jun 2017
Study completion30 Jun 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: 964 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02221284
Sponsor's protocol ID: 121-016
Other IDs: JapicCTI-142609
Status last verified: Oct 2019
First submitted: 18 Aug 2014
Last updated: 6 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 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alogliptin (Nesina) Tablets Specified Drug-use Survey "Type 2 Diabetes Mellitus: Combination Therapy With Hypoglycemic Drug (Insulin Preparation or Rapid-acting Insulin Secretagogues, Etc)"
ClinicalTrials.gov ID: NCT02221284
Acronym / sponsor ID: 121-016
Conditions: Type 2 Diabetes Mellitus
Keywords: Pharmacological therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 964 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 30 Jun 2014 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: 30 Jun 2017 (actual)
First posted: 20 Aug 2014 (estimated)
Results: Posted 19 Jul 2019

Clinical summary

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

Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.

Detailed description

For adults, 25 mg of alogliptin is usually administered orally once daily.

Study design

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

Arm	Type	Receives
Alogliptin	–	Drug: AlogliptinAlogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Type 2 diabetes mellitus

Key inclusion criteria (4 listed)

Use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin secretagogues, excluding other types of hypoglycemic agents (e.g., α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)*, in addition to dietary/exercise therapy
For use of alogliptin tablets in combination with these agents, a specified drug-use survey is currently ongoing.

Key exclusion criteria (4 listed)

-Type 2 diabetic patients who meet any of the following criteria are excluded from this survey: Patients with contraindications for alogliptin tablets
Those with severe ketosis, in a state of diabetic coma or precoma, or with type 1 diabetes mellitus [Quickly rectifying hyperglycemia with administration of intravenous fluid or insulin is essential in these patients; therefore, administration of alogliptin tablets is not appropriate.]
Those with severe infections, before or after surgery, or with serious trauma [Controlling blood glucose with an injection of insulin is desirable for these patients; therefore, administration of alogliptin tablets is not appropriate.]
Those with a history of hypersensitivity to any of the ingredients of alogliptin tablets

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 TabletsAlogliptin tablets	Drug	Alogliptin

Primary outcome

Percentage of Participants Who Had One or More Adverse Reactions
Time frame: Up to Month 12
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are 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.

6 secondary outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, and final assessment point (up to Month 12)
Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)
Time frame: Baseline, and final assessment point (up to Month 12)
Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)
Time frame: Baseline, and final assessment point (up to Month 12)
Change From Baseline in Laboratory Test Values (Fasting Insulin Level)
Time frame: Baseline, and final assessment point (up to Month 12)
Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])
Time frame: Baseline, and final assessment point (up to Month 12)
Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])
Time frame: Baseline, and final assessment point (up to Month 12)

Results and safety

Results posted to the registry on 19 Jul 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
Overall Population	964	903

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

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

Measure	Alogliptin + Insulin n = 573	Alogliptin + Glinide n = 166	Alogliptin + SGLT-2 Inhibitor n = 102	Alogliptin + Other n = 62
Value	5.41	1.20	0.98	0.00

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

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Month 12. Other adverse events reported at 1.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alogliptin + Insulin	3 of 573 (0.5%)	10 of 573 (1.7%)	3 of 573
Alogliptin + Glinide	0 of 166 (0%)	2 of 166 (1.2%)	0 of 166
Alogliptin + SGLT-2 Inhibit	0 of 102 (0%)	0 of 102 (0%)	0 of 102
Alogliptin + Other	0 of 62 (0%)	0 of 62 (0%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 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
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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

2 sites 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 2 sites 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 6 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 2 sites 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 19 Jul 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 Reactions (time frame: Up to Month 12). 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 NCT02221284.

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 6 Nov 2019.