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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1374 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.

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Detailed Description

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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 thiazolidinediones in patients with type 2 diabetes mellitus in a routine clinical setting.

Participants will be patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy. The planned sample size is 1,000 subjects.

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

Conditions

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Type 2 Diabetes Melitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alogilptin 25mg, tablets, orally, once daily, up to 12 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 who did not adequately respond to the following treatment • Treatment with thiazolidinediones in addition to diet therapy and exercise therapy

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