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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: NesinaAct® Tablet


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NesinaAct® Tablet<br>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<br>* NesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy