| Primary | 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. | Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety. | Posted | | Number | 95% Confidence Interval | percentage of participants | | First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks) | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
| | | Title | Denominators | Categories |
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| SAEs | | | | SADRs | | |
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| Primary | 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. | Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety. | Posted | | Number | 95% Confidence Interval | percentage of participants | | First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks) | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Primary | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 13 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Primary | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 26 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Primary | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 39 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Primary | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Primary | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 153 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Primary | 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. | Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety. | Posted | | Number | 95% Confidence Interval | percentage of participants | | First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks) | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Primary | 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. | Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety. | Posted | | Number | 95% Confidence Interval | percentage of participants | | First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks) | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Secondary | Change From Baseline in Haemoglobin A1c (HbA1c) Levels | HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin. | Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | | Mean | Standard Deviation | percentage of HbA1c | | Baseline, Weeks 13 and 26 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Secondary | Change From Baseline in Fasting Serum Glucose | | Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | | Mean | Standard Deviation | g/dL | | Baseline, Weeks 13 and 26 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Secondary | 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. | Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Weeks 13 and 26 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Secondary | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) | | Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Weeks 13 and 26 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Secondary | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) | | Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Weeks 13 and 26 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Secondary | Change From Baseline in Body Weight | | Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | | Mean | Standard Deviation | kg | | Baseline, Weeks 13 and 26 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Secondary | Change From Baseline in Systolic Blood Pressure | | Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline, Weeks 13 and 26 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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| Secondary | Change From Baseline in Diastolic Blood Pressure | | Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline, Weeks 13 and 26 | | | | ID | Title | Description |
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| OG000 | 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, were observed in this study. |
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