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 Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1026 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-28

Study Completion Date

2019-10-31

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.

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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.

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 and Metformin hydrochloride

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.

Alogliptin and Metformin hydrochloride

Intervention Type DRUG

Alogliptin and Metformin hydrochloride combination tablets

Interventions

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Alogliptin and Metformin hydrochloride

Alogliptin and Metformin hydrochloride combination tablets

Intervention Type DRUG

Other Intervention Names

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Inisync combination tablets

Eligibility Criteria

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Inclusion Criteria

* Participants should meet one or more of the following:

1. Have renal impairment (mild)
2. Have hepatic impairment (mild or moderate)
3. Elderly (aged 65 years or more)