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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Trelagliptin

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.

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Takeda selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure as part of routine medical care.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trelagliptin 25 mg; Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.	Drug: Trelagliptin; Trelagliptin tablets; Other Names: Zafatek tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): January 31, 2023
• Study Completion (ACTUAL): January 31, 2023

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (ACTUAL): February 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2; Kidney Failure, Chronic
• Other Study ID Numbers: Trelagliptin-4004; JapicCTI-205186 (REGISTRY: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No