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Completed

NCT Number: NCT04980040

A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea

The purpose of this study is to evaluate safety by determining the incidence rates of all adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected in the precautions for use, ADRs already known, non-serious ADRs and other safety related information among participants who have received alogliptin for type 2 diabetes mellitus.

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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

Andong, South Korea

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About this study

This is a long-term prospective, observational post-marketing surveillance study of alogliptin in participants with T2DM. The study assessed the safety and effectiveness of alogliptin for its approved indication within a real-world setting in South Korea.

The study will enroll approximately 3000 participants. The data is collected prospectively at the study sites and recorded in electronic case report forms (e-CRFs). All the participants are assigned to a single observational cohort:

  • Nesina® Tablet

The multi-center study is conducted in South Korea. Data is collected at 13 and 26 weeks after enrollment during standard of care office visits. The overall study was conducted during re-examination period of approximately 5 years and 4 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Had one of the following treatments with alogliptin for the first time as an adjunct to diet and exercise to improve glycemic control:
  • Monotherapy with alogliptin
  • Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with metformin or sulfonylurea or thiazolidinedione single therapy
  • Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with thiazolidinedione and metformin combination therapy
  • Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with insulin (single therapy or combination with metformin) therapy
  • Combination therapy with metformin in patients who have no prior history of antidiabetic medication and may not achieve adequate glycemic control with monotherapy alogliptin

Exclusion criteria

  • Had alogliptin treatment outside of the locally approved label in Korea
  • Had a contraindication for the use of alogliptin (as described in the Korean product label)

Treatment and study plan

Alogliptin Benzoate

Drug

Alogliptin benzoate tablets

Other names: Nesina® Tablet

Primary outcomes

  1. Percentage of Participants With Serious Adverse Events (SAEs)

    Time frame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 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. 95% Confidence Interval was calculated using exact method.

  2. Percentage of Participants With Serious Adverse Drug Reactions (ADRs)

    Time frame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)

    Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. 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. 95% Confidence Interval was calculated using exact method.

  3. Percentage of Participants With Unexpected Adverse Events

    Time frame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)

    An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. 95% Confidence Interval was calculated using exact method.

  4. Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs)

    Time frame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)

    Unexpected ADRs are unexpected AEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method.

Secondary outcomes

  1. Haemoglobin (HbA1c) Levels

    Time frame: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration

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

  2. Fasting Blood Glucose Levels

    Time frame: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration

  3. Percentage of Participants With HbA1c < 7.00%

    Time frame: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration

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

  4. Percentage of Participants With Overall Improvement and Final Effectiveness Assessment

    Time frame: Up to Week 26

    Participants were assessed for overall improvement and effectiveness assessments as per the following categories: 'Improved - signs and symptoms are significantly improved'; 'Unchanged - improvement in signs and symptoms is not significant or there is no change in signs and symptoms'.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Post Marketing Surveillance Protocol for Nesina® Tablet [Monotherapy or Combination Therapy in Type 2 Diabetic Patients]

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2021
Registry last updated
Apr 5, 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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