Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-08

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alogliptin 25mg, tablets, orally, once daily, up to 36 months

Alogliptin

Intervention Type DRUG

Alogliptin tablets

Interventions

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Alogliptin

Alogliptin tablets

Intervention Type DRUG

Other Intervention Names

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Nesina; SYR-322

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:

1. Diet therapy and exercise therapy alone
2. In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor

Exclusion Criteria

* Patients contraindicated for Nesina

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No