DS-1150b is being developed by Daiichi Sankyo for the treatment of Type 2 Diabetes Mellitus. This is a Phase I, single-blind (subjects and principal investigator blinded, Sponsor unblinded), placebo-controlled, randomized, 2-part, sequential, single ascending dose, single center study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of DS-1150b in healthy subjects and subjects with Type 2 Diabetes Mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States
area under curve (AUC)
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
Time frame: 24 days, Day -5 to Day 19
maximum plasma concentration (Cmax)
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
Time frame: 24 days, Day -5 to Day 19
terminal elimination half-life (t1/2)
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
Time frame: 24 days, Day -5 to Day 19
time to reach maximum plasma concentration (Tmax)
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
Time frame: 24 days, Day -5 to Day 19
measure the effects on Insulin and C-peptide Levels
To assess the effects of single oral dose of DS-1150b on insulin and C-peptide levels in subjects with Type 2 Diabetes Mellitus.
Time frame: 24 days, Day -5 to Day 19
number of patients experiencing adverse events
To assess the safety and tolerability of single oral dose of DS-1150b in subjects with Type 2 diabetes mellitus.
Time frame: 24 days, Day -5 to Day 19
measure the effects on glucagon Levels
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To assess the effects of single oral dose of DS-1150b on glucagon levels in subjects with Type 2 Diabetes Mellitus.
Time frame: 24 days, Day -5 to Day 19
number of patients experiencing laboratory adverse events
To assess the safety and tolerability of single oral dose of DS-1150b in subjects with Type 2 diabetes mellitus.
Time frame: 24 days, Day -5 to Day 19