N/A
Completed N=3,198
Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"
Source: ClinicalTrials.gov NCT03555591 ↗Enrolled (actual)
3,198
Serious AEs
5.4%
Results posted
Sep 2023
Primary outcomePrimary: Number of Participants Who Had One or More Adverse Events — 390 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had One or More Adverse Events |
390 | — |
| PRIMARY Number of Participants Who Had One or More Adverse Drug Reactions |
96 | — |
| SECONDARY Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) |
-0.24813; -0.40573; -0.43716; -0.44281; -0.33933; -0.34909 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
-11.733; -11.896; -13.816; -14.698; -10.999; -7.056 | — |
| SECONDARY Change From Baseline in Fasting Insulin Level |
-7.079; -5.520; -6.999; -4.354; -4.905; -6.601 | — |
| SECONDARY Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) |
-26.523; -21.155; -23.442; -16.312; -21.949; -34.083 | — |
| SECONDARY Change From Baseline in Fasting Glucagon |
-7.88; -9.22; 6.65; -1.41; 10.38; -3.56 | — |
| SECONDARY Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) |
78.0; 81.9; 86.1; 87.3; 88.8; 87.5 | — |
| SECONDARY Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) |
44.3; 50.3; 58.4; 60.9; 62.5; 58.5 | — |
| SECONDARY Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) |
6.0; 6.8; 8.7; 9.8; 11.0; 8.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03555591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.