Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | 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:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants who had One or More Adverse Events [Up to Month 36]
Secondary Outcome Measures
- Change from Baseline in Glycosylated Hemoglobin (HbA1c) [Baseline, up to final assessment point (up to Month 36)]
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 36) relative to baseline.
- Change from Baseline in Fasting Blood Glucose [Baseline, up to final assessment point (up to Month 36)]
The change in the value of fasting blood glucose collected at final assessment point (up to Month 36) relative to baseline.
- Change from Baseline in Fasting Insulin Level [Baseline, up to final assessment point (up to Month 36)]
The change in the value of fasting insulin collected at final assessment point (up to Month 36) relative to baseline.
- Change from Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-β) [Baseline, up to final assessment point (up to Month 36)]
The change in the value of HOMA-β collected at final assessment point (up to Month 36) relative to baseline. HOMA-β will be calculated by (fasting insulin multiplied by a constant [360]) divided by (fasting blood glucose minus 63).
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Takeda Selected Site | Tokyo | Japan |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Trelagliptin-5001
- JapicCTI-183980