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

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

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) once daily by physicians in the real-world clinical practice setting over a period of 26 weeks.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: NesinaAct® Tablet

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.

• Study Type: Observational
• Enrollment (Actual): 730

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
  • Chuncheon, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Gangneung-si, Korea, Republic of
  • Goyang-si, Korea, Republic of
  • Jeonju, Korea, Republic of
  • Seongam, Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: NesinaAct® Tablet; NesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Haemoglobin A1c (HbA1c) Levels	HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.	Baseline, Weeks 13 and 26
Change From Baseline in Fasting Serum Glucose		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.	Baseline, Weeks 13 and 26
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)		Baseline, Weeks 13 and 26
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)		Baseline, Weeks 13 and 26
Change From Baseline in Body Weight		Baseline, Weeks 13 and 26
Change From Baseline in Systolic Blood Pressure		Baseline, Weeks 13 and 26
Change From Baseline in Diastolic Blood Pressure		Baseline, Weeks 13 and 26

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2015
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Alogliptin-Pio-5002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No