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"

Takeda

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Alogliptin and Metformin hydrochloride

Study type: Observational

Funder types: Industry

Identifiers

NCT03555565

Alogliptin-Met-5003

JapicCTI-183979 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,026 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

• Participants with any contraindication for study drug.

Trial design

1,026 participants in 1 patient group

Alogliptin and Metformin hydrochloride

Description:

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.

Treatment:

Drug: Alogliptin and Metformin hydrochloride