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

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Drug: Alogliptin


Participation Criteria
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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: Diet therapy and exercise therapy alone In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor Exclusion Criteria: Patients contraindicated for Nesina 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.) 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.) Patients with a history of hypersensitivity to any ingredient of Nesina
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alogliptin 25mg, tablets, orally, once daily, up to 36 months<br> | Drug: Alogliptin<br>* Alogliptin tablets<br>* Other names: Nesina; SYR-322;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience at Least One Adverse Events |  | Up to Month 36 | 
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at month 36 relative to baseline. | Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose collected at month 36 relative to baseline. | Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy