Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age

Study Overview
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Brief Summary
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The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.

Detailed Description
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The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more). This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600. This multi-center observational trial will be conducted in Japan.

Official Title
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Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Alogliptin and Metformin hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants should meet one or more of the following: Have renal impairment (mild) Have hepatic impairment (mild or moderate) Elderly (aged 65 years or more) Exclusion Criteria: Participants with any contraindication for study drug.
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 and Metformin hydrochloride<br>Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. | Drug: Alogliptin and Metformin hydrochloride<br>* Alogliptin and Metformin hydrochloride combination tablets<br>* Other names: Inisync combination tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had One or More Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 final assessment point (up to Month 12) relative to baseline. | Baseline, up to final assessment point (up to Month 12) | 
| Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline. | Baseline, up to final assessment point (up to Month 12) | 
| Change From Baseline in Fasting Insulin Level | The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline. | Baseline, up to final assessment point (up to Month 12) |