A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
Not Applicable
Completed
- Conditions
- Type2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02628392
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief Summary
The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus.
- Detailed Description
The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of DS-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. In addition, the clinical positioning of DS-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 368
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DS-8500a 25 mg QD DS-8500a DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule DS-8500a 25 mg QD placebo DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule DS-8500a 50 mg QD placebo DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule DS-8500a 75 mg QD DS-8500a DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule DS-8500a 75 mg QD placebo DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule placebo placebo placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively. Sitagliptin Sitagliptin capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet Sitagliptin placebo capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet DS-8500a 50 mg QD DS-8500a DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
- Primary Outcome Measures
Name Time Method change in HbA1c baseline (Day -1) to Week 12 HbA1c = glycated hemoglobin
- Secondary Outcome Measures
Name Time Method change in serum insulin baseline (Day -1) to Week 12 change in AUC 0-3h proinsulin baseline (Day -1) to Week 12 change in AUC 0-3h C-peptide baseline (Day -1) to Week 12 change in PYY baseline (Day -1) to Week 12 change in AUC 0-3h PYY baseline (Day -1) to Week 12 change in total GLP-1 baseline (Day -1) to Week 12 change in AUC 0-3h total GLP-1 baseline (Day -1) to Week 12 change in active GLP-1 baseline (Day -1) to Week 12 change in AUC 0-3h active GLP-1 baseline (Day -1) to Week 12 change in C-peptide baseline (Day -1) to Week 12 change in total cholesterol baseline (Day -1) to Week 12 change in HDL cholesterol baseline (Day -1) to Week 12 change in LDL cholesterol baseline (Day -1) to Week 12 change in triglyceride baseline (Day -1) to Week 12 change in total AUC 0-3h GLP-1 baseline (Day -1) to Week 4 change in plasma glucose baseline (Day -1) to Week 12 change in AUC 0-3h serum insulin baseline (Day -1) to Week 12 change in proinsulin baseline (Day -1) to Week 12 change in HbA1c baseline (Day -1) to Week 8 proportion of subjects with HbA1c <7.0 baseline (Day -1) to Week 12 proportion of subjects who achieve HbA1c \<7.0
change in AUC derived from plasma glucose baseline (Day -1) to Week 12 pharmacodynamics profile consists of AUC, Cmax, Tmax
change in total GIP baseline (Day -1) to Week 12 change in AUC 0-3h total GIP baseline (Day -1) to Week 12 change in glucagon baseline (Day -1) to Week 12 change in AUC 0-3h glucagon baseline (Day -1) to Week 12 change in 1,5 AG baseline (Day -1) to Week 12 change in AUC 0-3h 1,5 AG baseline (Day -1) to Week 12
Trial Locations
- Locations (1)
Heishinkai Medical Group Incorporated OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan