Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Trelagliptin; Daily DPP-4 inhibitor
Intervention description: Trelagliptin 100 mg or 50 mg; Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin
Intervention MeSH terms: Dipeptidyl-Peptidase IV Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the reduction in treatment burden during 12 weeks of
      trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy
      only.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants diagnosed as type 2 diabetes.

          2. Participants with a stable diet and exercise therapy only for at least 12 weeks prior
             to the start of the screening period.

          3. Participants who require a DPP-4 inhibitor treatment.

          4. Participants with Hemoglobin A1c (HbA1c) >=6.5 % and <10.0 % at the start of the
             screening period.

          5. Participants who completed DTR-QOL questionnaire at the start of the screening period.

          6. Participants who have received less than 2 types of medication for treatment of
             comorbidities (such as hypertension or dyslipidemia) at the start of the screening
             period (any number of daily doses).

          7. Participants who, in the opinion of the principal investigator or the investigator,
             are capable of understanding the content of the clinical study and complying with the
             study protocol requirements.

          8. Participants who can provide the written informed consent prior to the initiation of
             any study procedures.

          9. Participants aged >=20 years at the time of informed consent.

         10. Outpatient.

        Exclusion Criteria:

          1. Participants who are receiving any oral anti-diabetic medication for the treatment of
             type 2 diabetes at the start of the screening period.

          2. Participants diagnosed with type 1 diabetes.

          3. Participants with severe renal impairment or renal failure (e.g., estimated glomerular
             filtration rate (eGFR) <30 mL/min/1.73 m^2 or on dialysis).

          4. Participants with serious heart disease or cerebrovascular disorder, or serious
             pancreatic, blood, or other disease.

          5. Participants with a history of gastrointestinal resection.

          6. Participant with a proliferative diabetic retinopathy.

          7. Participant with malignancy.

          8. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.

          9. Pregnant, lactating or planning pregnancy during the study period.

         10. Participants who may need to add or discontinue concomitant medication or change the
             dose during the study period.

         11. Participants who will require treatment with a prohibited concomitant medication
             during the study period.

         12. Participants participating in other clinical studies.

         13. Participants assessed ineligible in the study by the principal investigator or the
             investigator.