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

NCT ID: NCT04980040

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3623 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-19
• Study Completion Date: 2019-08-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Nesina® Tablet

Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, are observed in this study.

Alogliptin Benzoate

Intervention Type: DRUG

Alogliptin benzoate tablets

Interventions

Alogliptin Benzoate

Alogliptin benzoate tablets

Intervention Type: DRUG

Other Intervention Names

Nesina® Tablet

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Andong, , South Korea

Anyang-si, , South Korea

Bucheon-si, , South Korea

Busan, , South Korea

Daegu, , South Korea

Daejeon, , South Korea

Gimhae, , South Korea

Gongju, , South Korea

Goyang-si, , South Korea

Gwangju, , South Korea

Gyeongju, , South Korea

Incheon, , South Korea

Jeonju, , South Korea

Namyangju, , South Korea

Osan, , South Korea

Seongnam, , South Korea

Seongnam-si, , South Korea

Seoul, , South Korea

Suncheon, , South Korea

Suwon, , South Korea

Ulsan, , South Korea

Wŏnju, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Alogliptin-6001

Identifier Type: -

Identifier Source: org_study_id