A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea

An observational study of Type 2 Diabetes Mellitus, run by Takeda at 8 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this post marketing surveillance (PMS) study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) in participants who are treated for type 2 diabetes mellitus under NesinaAct® tablet therapy (alogliptin/pioglitazone)… Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: NesinaAct® Tablet
Type of treatment: Pill or oral medicine
How many people: 730 participants
Where: 8 sitesSouth Korea
Study dates: 2 Oct 2015to 30 Aug 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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.

Who may be able to join

Participants inadequately controlled on diet and exercise.
Participants inadequately controlled on metformin alone.
Participants inadequately controlled on pioglitazone alone.
Participants inadequately controlled on metformin and pioglitazone combination therapy.
Participants switching from alogliptin co-administered with pioglitazone.

Who cannot join

Participants treated with study drug outside of the locally approved label in Korea.
Participants with contraindication for the use of study drug (as described in the Korean product label).

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

South Korea8 sites

Study site
Busan
Study site
Chuncheon
Study site
Daejeon
Study site
Gangneung-si
Study site
Goyang-si
Study site
Jeonju
Study site
Seongam
Study site
Seoul

Other trials in South Korea

About this study

Official title: Post-Marketing Surveillance Study on NesinaAct Tablet® Use Among Type 2 Diabetes Mellitus Patients in Korea

Read the detailed description

The drug being tested in this survey is called NesinaAct® tablet. A surveillance is planned to examine safety and effectiveness of NesinaAct® tablet therapy in participants who are being treated for type 2 diabetes mellitus.

The study will enroll approximately 730 patients.

The study observes percentage of participants with adverse events (AEs) including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) administered a dose of NesinaAct® tablet (alogliptin/pioglitazone) once daily as prescribed by the physician in routine practice over a period of 26 weeks.

This multi-center trial is conducted in a total of 19 sites in Korea.

The data is collected between October 2 2015 to August 30 2019 from the re-examination period up to 26 weeks.

Conditions: Type 2 Diabetes Mellitus
Being tested: NesinaAct® Tablet
Keywords: Drug 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.

NesinaAct® TabletDrug
NesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.

Study groups in NCT04980014
Study group	Role	What they receive
NesinaAct® Tablet		Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, are observed in this study. Receives: Drug: NesinaAct® Tablet

What is being measured

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

Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method.
Measured: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions
An AE is any and all undesirable or unintended signs (including abnormal clinical laboratory values), symptoms, or disease that are incurred when the drug is administered, and is not related to causal relationship with the drug. An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug. 95% Confidence Interval was calculated using exact method.
Measured: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Percentage of Participants With Expected/Already Known ADRs at Week 13
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Measured: Week 13
Percentage of Participants With Expected/Already Known ADRs at Week 26
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Measured: Week 26
Percentage of Participants With Expected/Already Known ADRs at Week 39
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Measured: Week 39
Percentage of Participants With Expected/Already Known ADRs at Week 52
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Measured: Week 52
Percentage of Participants With Expected/Already Known ADRs at Week 153
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Measured: Week 153
Percentage of Participants With Non-serious ADRs
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. 95% Confidence Interval was calculated using exact method.
Measured: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
Presence and absence of significant data in laboratory results were recorded. 95% Confidence Interval was calculated using exact method.
Measured: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)

Secondary outcomes (8)

Change From Baseline in Haemoglobin A1c (HbA1c) Levels
HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.
Measured: Baseline, Weeks 13 and 26
Change From Baseline in Fasting Serum Glucose
Measured: Baseline, Weeks 13 and 26
Change From Baseline in Total Cholesterol
Total cholesterol is a measure of the total amount of cholesterol in the blood. It includes both low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol.
Measured: Baseline, Weeks 13 and 26
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Measured: Baseline, Weeks 13 and 26
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
Measured: Baseline, Weeks 13 and 26
Change From Baseline in Body Weight
Measured: Baseline, Weeks 13 and 26
Change From Baseline in Systolic Blood Pressure
Measured: Baseline, Weeks 13 and 26
Change From Baseline in Diastolic Blood Pressure
Measured: Baseline, Weeks 13 and 26

Timeline

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

2 Oct 201530 Aug 2019

First posted28 Jul 2021
Study start2 Oct 2015
Primary completion30 Aug 2019
Study completion30 Aug 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: 730 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04980014
Sponsor's protocol ID: Alogliptin-Pio-5002
Status last verified: Dec 2021
First submitted: 26 Jul 2021
Last updated: 7 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
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 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Marketing Surveillance Study on NesinaAct Tablet® Use Among Type 2 Diabetes Mellitus Patients in Korea
ClinicalTrials.gov ID: NCT04980014
Acronym / sponsor ID: Alogliptin-Pio-5002
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 730 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 2 Oct 2015 (actual)
Primary completion: 30 Aug 2019 (actual)
Study completion: 30 Aug 2019 (actual)
First posted: 28 Jul 2021 (actual)
Results: Posted 7 Mar 2022

Clinical summary

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

Detailed description

The study will enroll approximately 730 patients.

This multi-center trial is conducted in a total of 19 sites in Korea.

The data is collected between October 2 2015 to August 30 2019 from the re-examination period up to 26 weeks.

Study design

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

Arm	Type	Receives
NesinaAct® Tablet	–	Drug: NesinaAct® TabletParticipants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, are observed in this study.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.

Key inclusion criteria (5 listed)

Participants inadequately controlled on diet and exercise.
Participants inadequately controlled on metformin alone.
Participants inadequately controlled on pioglitazone alone.
Participants inadequately controlled on metformin and pioglitazone combination therapy.
Participants switching from alogliptin co-administered with pioglitazone.

Key exclusion criteria (2 listed)

Participants treated with study drug outside of the locally approved label in Korea.
Participants with contraindication for the use of study drug (as described in the Korean product label).

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
NesinaAct® TabletNesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.	Drug	NesinaAct® Tablet

Primary outcome

Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method.
Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions
Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
An AE is any and all undesirable or unintended signs (including abnormal clinical laboratory values), symptoms, or disease that are incurred when the drug is administered, and is not related to causal relationship with the drug. An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug. 95% Confidence Interval was calculated using exact method.
Percentage of Participants With Expected/Already Known ADRs at Week 13
Time frame: Week 13
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Percentage of Participants With Expected/Already Known ADRs at Week 26
Time frame: Week 26
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Percentage of Participants With Expected/Already Known ADRs at Week 39
Time frame: Week 39
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Percentage of Participants With Expected/Already Known ADRs at Week 52
Time frame: Week 52
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Percentage of Participants With Expected/Already Known ADRs at Week 153
Time frame: Week 153
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Percentage of Participants With Non-serious ADRs
Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. 95% Confidence Interval was calculated using exact method.
Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Presence and absence of significant data in laboratory results were recorded. 95% Confidence Interval was calculated using exact method.

8 secondary outcomes

Change From Baseline in Haemoglobin A1c (HbA1c) Levels
Time frame: Baseline, Weeks 13 and 26
Change From Baseline in Fasting Serum Glucose
Time frame: Baseline, Weeks 13 and 26
Change From Baseline in Total Cholesterol
Time frame: Baseline, Weeks 13 and 26
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline, Weeks 13 and 26
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
Time frame: Baseline, Weeks 13 and 26
Change From Baseline in Body Weight
Time frame: Baseline, Weeks 13 and 26
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline, Weeks 13 and 26
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline, Weeks 13 and 26

Results and safety

Results posted to the registry on 7 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NesinaAct® Tablet	730	655

Primary outcome: Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)

Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	NesinaAct® Tablet n = 655
SAEs	0.15 (0.00 to 0.85)
SADRs	0.00 (0.00 to 0.56)

Population analysed: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.

Primary outcome: Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions

Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	NesinaAct® Tablet n = 655
Unexpected AEs	4.58 (3.11 to 6.47)
Unexpected ADRs	1.22 (0.53 to 2.39)

Population analysed: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.

Primary outcome: Percentage of Participants With Expected/Already Known ADRs at Week 13

Time frame: Week 13. Number (95% Confidence Interval). Unit: percentage of participants

Measure	NesinaAct® Tablet n = 653
Value	1.99 (1.06 to 3.38)

Population analysed: Safety Analysis Set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.

Primary outcome: Percentage of Participants With Expected/Already Known ADRs at Week 26

Time frame: Week 26. Number (95% Confidence Interval). Unit: percentage of participants

Measure	NesinaAct® Tablet n = 515
Value	0.19 (0.00 to 1.08)

Population analysed: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NesinaAct® Tablet	1 of 655 (0.2%)	0 of 655 (0%)	0 of 655

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
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.

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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

8 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 8 sites in South Korea.

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 5 inclusion and 2 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 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. 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 7 Mar 2022). 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 With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) (time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)). The study lists 9 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 NCT04980014.

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 7 Mar 2022.