Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea

Takeda

Status: Completed

Conditions: Surveillance

Study type: Observational

Funder types: Industry

Identifiers

NCT01964950

JapicCTI-R160882 (Registry Identifier)

121-013

JapicCTI-132266 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.

Full description

This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and sulfonylurea in participants with type 2 diabetes mellitus in a routine clinical setting.

Participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy will be enrolled in this study. The planned sample size is 1,000.

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

Enrollment: 1,101 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who did not adequately respond to the following treatment • Treatment with sulfonylurea in addition to diet therapy and exercise therapy

Exclusion criteria

1. Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate).
2. Participants with severe infection, pre- or post-operative participants, or participants with serious traumatic injury (blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate).
3. Participants with a history of hypersensitivity to any ingredient of Nesina.

Trial design

1,101 participants in 1 patient group

Alogliptin

Description:

All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with Sulfonylurea (SU) or without SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.