Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

Takeda

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Alogliptin

Study type: Observational

Funder types: Industry

Identifiers

NCT01964963

JapicCTI-132283 (Registry Identifier)

121-015

Details and patient eligibility

About

The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Full description

This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.

Enrollment: 19,192 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patients with Haemoglobin A1c (HbA1c) [Japan Diabetes Society (JDS) value] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.

Exclusion criteria

-Patients contraindicated for alogliptin.

1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
3. Patients with a history of hypersensitivity to any ingredient of alogliptin.

Trial design

19,192 participants in 1 patient group

Alogliptin

Description:

Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.

Treatment:

Drug: Alogliptin