Main Inclusion Criteria;
1) Patients aged >= 20 years
2) Japanese patients with type 2 diabetes mellitus
3) Patients who have >= 7.0% and < 10.0% HbA1c
Main Exclusion Criteria;
- Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis
- Patients receiving or requiring treatment with insulin
- Patients with a body mass index (BMI) of < 18.5 kg/m2 or >= 35.0 kg/m2
- Patients with clinically evident renal impairment (estimated glomerular filtration rate [eGFR] of < 45 mL/min per 1.73 m2) or clinically significant renal disease
- Patients with fasting plasma glucose >= 240 mg/dL
20age old over
No limit
Both
Type 2 Diabetes Mellitus
investigational material(s)
Generic name etc : DS-8500a
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : Oral
control material(s)
Generic name etc : Sitagliptin
INN of investigational material : Sitagliptin
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : Oral
Change from baseline in HbA1c
- Change from baseline (Day -1) in HbA1c at Weeks 4 and 8
- Proportion of subjects who have achieved HbA1c of < 7.0% at Weeks 4, 8, and 12
- Change from baseline (Day -1) in fasting blood glucose at Weeks 2, 4, 8, and 12
