Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"

The purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus 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 survey is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 3000.

This multi-center observational trial will be conducted in Japan.

• Study Type: Observational
• Enrollment (Actual): 3198

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Takeda selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with type 2 diabetes mellitus in the routine clinical setting

Description

Inclusion Criteria:

• Type 2 diabetes mellitus patients

Exclusion Criteria:

1. Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
2. Have severe infection, perioperative status, or serious trauma
3. Have severe renal impairment or on dialysis due to end-stage renal disease
4. Have a history of hypersensitivity to any ingredients of this drug

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 100 mg; Trelagliptin 100 mg tablet, orally, once weekly for up to 36 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
Number of Participants Who Had One or More Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	36 months
Number of Participants Who Had One or More Adverse Drug Reactions	An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)	The reported data was the change in the mean value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.	Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Fasting Blood Glucose	The reported data was the change in the mean value of fasting blood glucose collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.	Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Fasting Insulin Level	The reported data was the change in the mean value of fasting insulin level collected between baseline and timepoints (up to final assessment point: Month 36).	Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)	The reported data was the change in the mean value of HOMA-beta. HOMA-beta measures as following; HOMA-beta = fasting insulin (microU/mL) ×360/ [fasting glucose (mg/dL) - 63].	Baseline, up to final assessment point (up to Month 36)
Change From Baseline in Fasting Glucagon	The reported data was the change in the mean value of fasting glucagon collected between baseline and timepoints (up to final assessment point: Month 36).	Baseline, up to final assessment point (up to Month 36)
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)	The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 8.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).	Baseline, up to final assessment point (up to Month 36)
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)	The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 7.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).	Baseline, up to final assessment point (up to Month 36)
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)	The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 6.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).	Baseline, up to final assessment point (up to Month 36)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, 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): May 1, 2016
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Trelagliptin-5001; JapicCTI-183980 (Registry Identifier: 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
• product manufactured in and exported from the U.S.: No