type 2 diabetes mellitus
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Research subjects 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. 2.Patients who are able to sign and date the informed consent form and information sheet prior to the start of study procedures 3.Patients diagnosed with type 2 diabetes mellitus 4.Patients with an HbA1c (NGSP value) value >= 6.5% and = 4 weeks before the start of the observation period 7.Patients, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) HMG-CoA reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period. 8.Men or women aged 20 years or older at the time of informed consent
Exclusion criteria
Exclusion criteria: 1.Patients who received anti-diabetic medications within 4 weeks prior to the start of the observation period 2.Patients who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors == 2.5-fold the upper limit of normal at the start of the observation period [Day -2]) 4.Patients with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance 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.Patients with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases 6.Patients with a history of gastric or small intestinal resection 7.Patients with proliferative diabetic retinopathy 8.Patients warranting insulin therapy for glycemic control (e.g, patients with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative patients, or serious trauma) 9.Patients with a history of hypersensitivity or allergy to DPP-4 inhibitors 10.Patients who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2) 11.Patients with any malignant tumors 12.Habitual drinkers whose average daily alcohol consumption is > 100 mL 13.Patients who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert 14.Patients anticipated to require any prohibited concomitant medications during the study period 15.Patients who are day and night lifestyle reversal 16.Patients 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 patients who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the standard deviation (SD) of 24-hour blood glucose values (mg/dL) Timeframe; Up to 31 days Change amount from the start of the observation period at each 7-day between Week 3 and Week 4 (between Day 22 and Day 28) of the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy]Change from baseline in AUC for blood glucose when specific blood glucose levels (110, 140, 160, or 180 mg/dL) are observed during the 3 hour time period after breakfast, lunch and evening meal; Change from baseline in AUC for blood glucose during periods when blood glucose levels reach 140, 160, or 180 mg/dL (hyperglycemia); Change from baseline in Time during periods when blood glucose levels reach 140, 160, or 180 mg/dL (hyperglycemia); Change from baseline in AUC during periods when blood glucose is less than 70 mg/dL (hypoglycemia); Change from baseline in peak postprandial glucose levels over time 3 hours after breakfast, lunch, and evening meal; Change from baseline in maximum variation of blood glucose levels over time between before and after breakfast, lunch, and evening meal; Changes from baseline in MAGE (Mean Amplitude Glycemic Excursions); Change from baseline in mean 24-hour blood glucose levels; Change from baseline in mean daytime blood glucose levels; Change from baseline in mean nocturnal blood glucose levels; Change from baseline in AUC; Change from baseline in AUC over time during periods when blood glucose 110 mg/dL ; hypoglycemia) is observed; Change from baseline in the SD of 24-hour blood glucose values, daytime blood glucose values and nocturnal blood glucose values; [Safety] Adverse events Timeframe; Up to 31days | — |
Outcome results
None listed