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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
368
DS-8500a tablets 25mg, 50mg, 75mg
capsules
matching DS-8500a tablets and sitagliptin capsules
Heishinkai Medical Group Incorporated OCROM Clinic
Suita-shi, Osaka, Japan
change in HbA1c
HbA1c = glycated hemoglobin
Time frame: baseline (Day -1) to Week 12
change in HbA1c
Time frame: baseline (Day -1) to Week 4
change in HbA1c
Time frame: baseline (Day -1) to Week 8
proportion of subjects with HbA1c <7.0
proportion of subjects who achieve HbA1c \<7.0
Time frame: baseline (Day -1) to Week 12
change in plasma glucose
Time frame: baseline (Day -1) to Week 4
change in plasma glucose
Time frame: baseline (Day -1) to Week 12
change in AUC derived from plasma glucose
change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax)
Time frame: baseline (Day -1) to Week 4
change in AUC derived from plasma glucose
pharmacodynamics profile consists of AUC, Cmax, Tmax
Time frame: baseline (Day -1) to Week 12
change in serum insulin
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h serum insulin
Time frame: baseline (Day -1) to Week 4
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change in serum insulin
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h serum insulin
Time frame: baseline (Day -1) to Week 12
change in proinsulin
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h proinsulin
Time frame: baseline (Day -1) to Week 4
change in proinsulin
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h proinsulin
Time frame: baseline (Day -1) to Week 12
change in C-peptide
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h C-peptide
Time frame: baseline (Day -1) to Week 4
change in C-peptide
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h C-peptide
Time frame: baseline (Day -1) to Week 12
change in PYY
PYY = peptide YY
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h PYY
Time frame: baseline (Day -1) to Week 4
change in PYY
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h PYY
Time frame: baseline (Day -1) to Week 12
change in total GLP-1
GLP-1 = Glucagon-Like Peptide-1
Time frame: baseline (Day -1) to Week 4
change in total AUC 0-3h GLP-1
Time frame: baseline (Day -1) to Week 4
change in total GLP-1
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h total GLP-1
Time frame: baseline (Day -1) to Week 12
change in active GLP-1
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h active GLP-1
Time frame: baseline (Day -1) to Week 4
change in active GLP-1
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h active GLP-1
Time frame: baseline (Day -1) to Week 12
change in total GIP
GIP = Gastric Inhibitory Polypeptide
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h total GIP
Time frame: baseline (Day -1) to Week 4
change in total GIP
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h total GIP
Time frame: baseline (Day -1) to Week 12
change in glucagon
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h glucagon
Time frame: baseline (Day -1) to Week 4
change in glucagon
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h glucagon
Time frame: baseline (Day -1) to Week 12
change in 1,5 AG
1,5 AG = 1,5 anhydrogucitol
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h 1,5 AG
Time frame: baseline (Day -1) to Week 4
change in 1,5 AG
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h 1,5 AG
Time frame: baseline (Day -1) to Week 12
change in total cholesterol
Time frame: baseline (Day -1) to Week 2
change in total cholesterol
Time frame: baseline (Day -1) to Week 4
change in total cholesterol
Time frame: baseline (Day -1) to Week 8
change in total cholesterol
Time frame: baseline (Day -1) to Week 12
change in HDL cholesterol
HDL = high density lipoprotein
Time frame: baseline (Day -1) to Week 2
change in HDL cholesterol
Time frame: baseline (Day -1) to Week 4
change in HDL cholesterol
Time frame: baseline (Day -1) to Week 8
change in HDL cholesterol
Time frame: baseline (Day -1) to Week 12
change in LDL cholesterol
LDL = low density lipoprotein
Time frame: baseline (Day -1) to Week 2
change in LDL cholesterol
Time frame: baseline (Day -1) to Week 4
change in LDL cholesterol
Time frame: baseline (Day -1) to Week 8
change in LDL cholesterol
Time frame: baseline (Day -1) to Week 12
change in triglyceride
Time frame: baseline (Day -1) to Week 2
change in triglyceride
Time frame: baseline (Day -1) to Week 4
change in triglyceride
Time frame: baseline (Day -1) to Week 8
change in triglyceride
Time frame: baseline (Day -1) to Week 12