Clinical trial NCT04980040: A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea
Official title: Post Marketing Surveillance Protocol for Nesina® Tablet [Monotherapy or Combination Therapy in Type 2 Diabetic Patients]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 3623
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with type 2 diabetes mellitus are observed.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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:

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

Primary outcomes:
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
measure: Percentage of Participants With Serious Adverse Drug Reactions (ADRs)
timeFrame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
measure: Percentage of Participants With Unexpected Adverse Events
timeFrame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
measure: Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs)
timeFrame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Secondary outcomes:
measure: Haemoglobin (HbA1c) Levels
timeFrame: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
measure: Fasting Blood Glucose Levels
timeFrame: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
measure: Percentage of Participants With HbA1c < 7.00%
timeFrame: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
measure: Percentage of Participants With Overall Improvement and Final Effectiveness Assessment
timeFrame: Up to Week 26
Other outcomes:
Locations:
city: Andong
country: Korea, Republic of
city: Anyang-si
country: Korea, Republic of
city: Bucheon-si
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gimhae
country: Korea, Republic of
city: Gongju
country: Korea, Republic of
city: Goyang-si
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeongju
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Namyangju-si
country: Korea, Republic of
city: Osan
country: Korea, Republic of
city: Seongnam-si
country: Korea, Republic of
city: Seongnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suncheon
country: Korea, Republic of
city: Suwon- si
country: Korea, Republic of
city: Suwon-si
country: Korea, Republic of
city: Ulsan
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: