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

The purpose of this study is to evaluate the effect of trelagliptin administered orally at a dose of 100 mg once weekly or alogliptin administered orally at a dose of 25 mg once daily for 4 weeks on glycemic variation in an exploratory manner as a primary objective and to evaluate the effect of difference method of administration of Dipeptidyl-peptidase (DPP)-4 on glycemic variation as secondary objective.

Inclusion criteria

• Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
• Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures.
• Participants diagnosed with type 2 diabetes mellitus.
• Participants with a glycated hemoglobin (HbA1c) [National Glycohemoglobin Standardization Program (NGSP value)] value ≥ 6.5% and < 8.5% at the start of the observation period (Day -2).
• Participants who experience a ≤ ±1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks.
• Participants receiving stable dietetic therapy and exercise therapy (if performed) for ≥ 4 weeks before the start of the observation period.
• Participants, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period.
• Men or women aged 20 years or older at the time of informed consent.

Exclusion criteria

• Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period.
• 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.
• 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]).
• 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]).
• Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases.
• Participants with a history of gastric or small intestinal resection.
• Participants with proliferative diabetic retinopathy.
• 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).
• Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
• Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2).
• Participants with any malignant tumors.
• Habitual drinkers whose average daily alcohol consumption is > 100 mL.
• Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert.
• Participants anticipated to require any prohibited concomitant medications during the study period.
• Participants who are day and night lifestyle reversal.
• Participants participating in any other clinical studies at the time of informed consent for this study.
• Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant.
• Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.