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.
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
3,198
Trelagliptin tablets
Takeda Selected Site
Tokyo, Japan
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.
Time frame: 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.
Time frame: 36 months
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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, up to final assessment point (up to Month 36)
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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/ \[fasting glucose (mg/dL) - 63\].
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline, up to final assessment point (up to Month 36)