Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Trelagliptin; Alogliptin
Intervention description: Trelagliptin tablets; Alogliptin tablets
Intervention MeSH terms: Alogliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants who have been diagnosed with type 2 diabetes mellitus.

          2. 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

          3. 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.

          4. Participants whose glycosylated hemoglobin (HbA1c) value measured within 8 weeks prior
             to the time of informed consent (Week 0) is below 10.0%.

          5. Participants who responded to Diabetes Treatment Satisfaction Questionnaire (DTSQ) at
             the time of informed consent (Week 0).

          6. Participants who were judged by the investigators capable to understand the contents
             of this clinical research and comply with them.

          7. Participants who are able to sign and date the Informed Consent Form before any
             clinical research procedure begins.

          8. Participants who are at least 20 years old at the time of giving the consent.

          9. Participants who are classified as outpatients.

        Exclusion Criteria:

          1. Participants who have a history of taking once-weekly dosing of DPP-4 inhibitor
             (trelagliptin or omarigliptin).

          2. 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).

          3. Participants who are being treated with twice-daily dosing of DPP-4 inhibitor
             (vildagliptin or anagliptin).

          4. Participants who are being treated with anti-diabetic fixed-dose combination pill
             contained a DPP-4 inhibitor.

          5. Participants with moderate or severe renal impairment (for example, participant whose
             estimated glomerular filtration rate (eGFR) is below 60 mL/min/1.73m^2).

          6. 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).

          7. Participants who have a history of hypersensitivity or allergy to DPP-4 inhibitor.

          8. Participants with serious heart disease, cerebrovascular disorder, or participants
             with serious disease in the pancreas, blood, etc.

          9. Participants with unstable proliferative diabetic retinopathy.

         10. Participants with malignant tumor.

         11. Participants who are pregnant, breast-feeding, possibly pregnant, or planning to
             become pregnant.

         12. Participants participating in other clinical studies.

         13. Participants who have been determined as inappropriate participants by the
             investigator.