A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
Type2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Adult, Developmental Phase II
Eligibility Criteria
Inclusion Criteria:
- Patients aged ≥ 20 years at the time of informed consent
- Japanese patients with type 2 diabetes
- Patients who have HbA1c ≥ 7.0% and < 10.0%
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
Sites / Locations
- Heishinkai Medical Group Incorporated OCROM Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
DS-8500a 25 mg QD
DS-8500a 50 mg QD
DS-8500a 75 mg QD
placebo
Sitagliptin
DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule
DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.
capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet