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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Trelagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus patients Exclusion Criteria: Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus Have severe infection, perioperative status, or serious trauma Have severe renal impairment or on dialysis due to end-stage renal disease Have a history of hypersensitivity to any ingredients of this drug
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trelagliptin 100 mg<br>Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care. | Drug: Trelagliptin<br>* Trelagliptin tablets<br>* Other names: Zafatek tablets;|

What is the study measuring?
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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) |