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

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Trelagliptin

Registration Number: NCT03555591

Lead Sponsor: Takeda

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3198

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trelagliptin 100 mg	Trelagliptin	Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had One or More Adverse Events	36 months	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.
Number of Participants Who Had One or More Adverse Drug Reactions	36 months	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)	Baseline, up to final assessment point (up to Month 36)	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.
Change From Baseline in Fasting Blood Glucose	Baseline, up to final assessment point (up to Month 36)	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.
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)	Baseline, up to final assessment point (up to Month 36)	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).
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)	Baseline, up to final assessment point (up to Month 36)	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/ \[fasting glucose (mg/dL) - 63\].
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)	Baseline, up to final assessment point (up to Month 36)	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).
Change From Baseline in Fasting Insulin Level	Baseline, up to final assessment point (up to Month 36)	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).
Change From Baseline in Fasting Glucagon	Baseline, up to final assessment point (up to Month 36)	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).
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)	Baseline, up to final assessment point (up to Month 36)	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).