An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus

Exclusion Criteria

• •1. Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period.
• •2. Participants who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors ≤ 4 weeks before the start of the observation period.
• •3. Participants with clinically evident hepatic dysfunction (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5-fold the upper limit of normal at the start of the observation period \[Day -2\]).
• •4. Participants with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance \< 50 mL/min or serum creatinine \> 1.4 mg/dL in men or \> 1.2 mg/dL in women \[equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg\] at the start of the observation period \[Day -2\]).
• •5. Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases.
• •6. Participants with a history of gastric or small intestinal resection.
• •7. Participants with proliferative diabetic retinopathy.
• •8. Participants warranting insulin therapy for glycemic control (e.g., participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative participants, or serious trauma).
• •9. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
• •10. Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2).
• •11. Participants with any malignant tumors.
• •12. Habitual drinkers whose average daily alcohol consumption is \> 100 mL.
• •13. Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert.
• •14. Participants anticipated to require any prohibited concomitant medications during the study period.
• •15. Participants who are day and night lifestyle reversal.
• •16. Participants participating in any other clinical studies at the time of informed consent for this study.
• •17. Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant.
• •18. Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.