Surveillance Clinical Trial
Official title:
Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in patients with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.
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 patients with type 2
diabetes mellitus in a routine clinical setting.
Participants will be patients with type 2 diabetes mellitus who responded inadequately to
treatment with sulfonylurea in addition to diet therapy and exercise therapy. The planned
sample size is 1,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.
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Observational Model: Cohort, Time Perspective: Prospective
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