The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
SOUSEIKAI Hakata Clinic
Hakata-ku, Fukuoka, Japan
First-phase and Second-phase secretion Insulin
First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)
Time frame: Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion C-peptide
First-phase and Second-phase secretion (C-peptide)
Time frame: Baseline to Day 28 (Period 1 and 2)
M value
M value:Mean of Glucose Infusion Rate from 90 to 120 min
Time frame: Baseline to Day 28 (Period 1 and 2)
M/I value
M/I value:M value / steady-state Insulin
Time frame: Baseline to Day 28 (Period 1 and 2)
Disposition Index
Disposition Index:Product of M value and First-phase secretion
Time frame: Baseline to Day 28 (Period 1 and 2)
Number and severity of Adverse Events
Time frame: Day 28 (Period 1 and 2)
plasma concentration of DS-8500a
Time frame: Day 28 (Period 1 and 2)
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