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

Takeda

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Alogliptin Benzoate

Study type: Observational

Funder types: Industry

Identifiers

NCT04980040

Alogliptin-6001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,623 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

3,623 participants in 1 patient group

Nesina® Tablet

Description:

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

Treatment:

Drug: Alogliptin Benzoate