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Completed

NCT Number: NCT04980014

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Busan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

NesinaAct® Tablet

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Change From Baseline in Haemoglobin A1c (HbA1c) Levels

    Time frame: Baseline, Weeks 13 and 26

    HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.

  2. Change From Baseline in Fasting Serum Glucose

    Time frame: Baseline, Weeks 13 and 26

  3. Change From Baseline in Total Cholesterol

    Time frame: Baseline, Weeks 13 and 26

    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.

  4. Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)

    Time frame: Baseline, Weeks 13 and 26

  5. Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)

    Time frame: Baseline, Weeks 13 and 26

  6. Change From Baseline in Body Weight

    Time frame: Baseline, Weeks 13 and 26

  7. Change From Baseline in Systolic Blood Pressure

    Time frame: Baseline, Weeks 13 and 26

  8. Change From Baseline in Diastolic Blood Pressure

    Time frame: Baseline, Weeks 13 and 26

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2021
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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