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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555591
• Other study ID #: Trelagliptin-5001
• Secondary ID: JapicCTI-183980
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: October 31, 2021

Study information

• Verified date: December 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3198
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Trelagliptin
Trelagliptin tablets

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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