NCT04285983

Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"

Specified Drug Use Surveillance on Zafatek Tablets 25 mg -Surveillance on Long-Term Use of Trelagliptin Tablets in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-Stage Renal Failure-

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 89 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.

Detailed description

The drug being tested in this study is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure. This study is an observational (non-interventional) study and will look at the long-term safety of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 100. This multi-center observational trial will be conducted in Japan.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Trelagliptin	Trelagliptin tablets

Timeline

• Start date: 2020-03-01
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2020-02-26
• Last updated: 2024-08-23
• Results posted: 2024-08-23

Locations

1 site across 1 country: Japan