Phase 4
Completed N=60
Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03231709 ↗Enrolled (actual)
60
Serious AEs
0.8%
Results posted
May 2019
Primary outcomePrimary: Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period — 4; 7; 8; 10 Participants — p=0.0141
◆ Published Evidence
Emerging
12citations · ~2 / year
Treatment preference for weekly versus daily DPP-4 inhibitors in patients with type 2 diabetes mellitus: outcomes from the TRINITY trial.
Summary
The purpose of this study is to examine the participant's preference for treatment with once-weekly dosing of DPP-4 inhibitor trelagliptin versus once-daily dosing of DPP-4 inhibitor alogliptin among the participants with type 2 diabetes mellitus who are being treated with once-daily dosing of DPP-4 inhibitor.
Linked Publications
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Treatment preference for weekly versus daily DPP-4 inhibitors in patients with type 2 diabetes mellitus: outcomes from the TRINITY trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period |
4; 7; 8; 10; 18; 13 | 0.0141 sig |
| SECONDARY Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors |
9; 13; 16; 0; 2; 5 | — |
| SECONDARY Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group) |
4; 5; 9; 0; 0; 3 | — |
| SECONDARY Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group) |
5; 8; 7; 0; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who have been diagnosed with type 2 diabetes mellitus.
- Participants who are being treated with any of the following DPP-4 inhibitors for at least 8 weeks prior to the time of informed consent (Week 0).
- Sitagliptin : 50 mg once daily
- Alogliptin : 25 mg once daily
- Linagliptin : 5 mg once daily
- Teneligliptin : 20 mg once daily
- Saxagliptin : 5 mg once daily
- Participants who were judged by the investigators possible to change the treatment from daily dosing of DPP-4 inhibitor shown in Inclusion Criteria 2 to study drug trelagliptin 100 mg or alogliptin 25 mg.
- Participants whose glycosylated hemoglobin (HbA1c) value measured within 8 weeks prior to the time of informed consent (Week 0) is below 10.0%.
- Participants who responded to Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the time of informed consent (Week 0).
- Participants who were judged by the investigators capable to understand the contents of this clinical research and comply with them.
- Participants who are able to sign and date the Informed Consent Form before any clinical research procedure begins.
- Participants who are at least 20 years old at the time of giving the consent.
- Participants who are classified as outpatients.
Exclusion Criteria
- Participants who have a history of taking once-weekly dosing of DPP-4 inhibitor (trelagliptin or omarigliptin).
- Participants who are being treated with drugs other than those for once-daily oral dosing for the purpose of treatment of chronic complication (for example, "BENET® Tablets 75 mg", a therapeutic agent for osteoporosis which is administered once monthly).
- Participants who are being treated with twice-daily dosing of DPP-4 inhibitor (vildagliptin or anagliptin).
- Participants who are being treated with anti-diabetic fixed-dose combination pill contained a DPP-4 inhibitor.
- Participants with moderate or severe renal impairment (for example, participant whose estimated glomerular filtration rate (eGFR) is below 60 mL/min/1.73m^2).
- Participants for whom blood sugar control by insulin preparations is desired (for example, participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, or serious trauma before or after surgery).
- Participants who have a history of hypersensitivity or allergy to DPP-4 inhibitor.
- Participants with serious heart disease, cerebrovascular disorder, or participants with serious disease in the pancreas, blood, etc.
- Participants with unstable proliferative diabetic retinopathy.
- Participants with malignant tumor.
- Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.
- Participants participating in other clinical studies.
- Participants who have been determined as inappropriate participants by the investigator.
Data sourced from ClinicalTrials.gov (NCT03231709) and the linked publication. 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.