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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-03

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alogliptin

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

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 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No