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"

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285983
• Other study ID #: Trelagliptin-4004
• Secondary ID: JapicCTI-205186
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Participants must be type 2 diabetes mellitus patients meeting the following conditions:

Have severe renal impairment or end-stage renal disease, with serum creatinine (mg/dL) or creatinine clearance (Ccr; mL/min) meeting the following criteria within 3 months before the start of treatment with this product

• Serum creatinine (mg/dL)*: male: > 2.4, female: > 2.0

• Ccr (mL/min): < 30 In patients with end-stage renal disease, this product may be administered irrespective of the time of hemodialysis.

• Estimated values corresponding to the Ccr (for persons aged 60 years weighing 65 kg)

Exclusion Criteria:

1. Participants with any of the following contraindications for trelagliptin will be excluded:

1. Patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus

2. Patient with severe infection, perioperative status, or serious trauma

3. Patient with a history of hypersensitivity to any ingredients of trelagliptin

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Failure, Chronic
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Trelagliptin
Trelagliptin tablets

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who had One or More Adverse Reactions	Adverse reactions are defined as adverse events that are considered as having a causal relationship with pharmaceutical product. Timeframe is defined as a duration from the first dose of trelagliptin up to 12 months (or up to discontinuation of drug administration).	Up to Month 12

External Links

•   To obtain more information on the study, click here/on this link