Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution Clinical Trial
Official title:
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
The purpose of this study is to determine the safety and efficacy of long-term treatment with
alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to
diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy,
and α-glucosidase inhibitor.
In addition, examining the safety and efficacy of alogliptin in patients with renal
impairment, information on the appropriate dosage of alogliptin according to the severity of
impaired renal function should be collected.
A special drug use surveillance is planned to examine the safety and efficacy of long-term
use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use
conditions.
Participants of this surveillance will be patients with type 2 diabetes mellitus who failed
to respond adequately to diet therapy and exercise therapy alone or to a combination of diet
therapy, exercise therapy, and α-glucosidase inhibitor. The planned sample size is 3,000
subjects.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily. Participants
will receive the drug as part of routine medical care.
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