NCT03555565

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"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,026 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Alogliptin and Metformin hydrochloride	Alogliptin and Metformin hydrochloride combination tablets

Timeline

• Start date: 2017-02-28
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2018-06-13
• Last updated: 2023-09-13
• Results posted: 2020-11-23

Locations

1 site across 1 country: Japan