The objective of this study is to assess pharmacodynamics, pharmacokinetics, and safety of ASP1941 in patients with type 1 diabetes mellitus when administered once daily (q.d.) for 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
Site JP00006
Aichi, Japan
Site JP00002
Fukuoka, Japan
Site JP00009
Gunma, Japan
Site JP00001
Ibaraki, Japan
Daily profile of plasma glucose levels
Time frame: up to Day 14
Area under the concentration-time curve (AUC) 0-24hr (AUC0-24h) of plasma glucose levels
Time frame: at Day -1, Day 1 and Day 14
AUC0-3h of plasma glucose levels
Time frame: at Day -1, Day 1 and Day 14
AUC0-4h of plasma glucose levels
Time frame: up to Day 14
AUC0-10h of plasma glucose levels
Time frame: up to Day 14
Fasting plasma glucose levels
Time frame: up to Day 21
Glycoalbumin
Time frame: up to Day 21
Urinary glucose excretion
Time frame: up to Day 14
Urinary glucose excretion rate
Time frame: up to Day 14
Urine volume
Time frame: up to Day 14
Urinary glucose concentration
Time frame: up to Day 15
Body weight
Time frame: up to Day 21
Renal glucose clearance
Time frame: up to Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site JP00005
Kanagawa, Japan
Site JP00008
Kanagawa, Japan
Site JP00003
Okayama, Japan
Site JP00004
Osaka, Japan
Site JP00010
Osaka, Japan
Site JP00011
Osaka, Japan
...and 1 more locations
Plasma concentration of unchanged ASP1941
Time frame: up to Day 14
Urinary concentration of unchanged ASP1941
Time frame: up to Day 14
Pharmacokinetics (PK) parameter of ASP1941 in plasma: AUC from time 0 extrapolated to infinity (AUCinf)
Time frame: at Day 1
PK parameter of ASP1941 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast)
Time frame: at Day 1 and Day 14
PK parameter of ASP1941 in plasma: AUC from the time of dosing to 24 hr (AUC0-24h)
Time frame: at Day 1 and Day 14
PK parameter of ASP1941 in plasma: Oral Clearance (CL/F)
Time frame: at Day 1 and Day 14
PK parameter of ASP1941 in plasma: Maximum concentration (Cmax)
Time frame: at Day 1 and Day 14
PK parameter of ASP1941 in plasma: Terminal Elimination Half-life (t1/2)
Time frame: at Day 1 and Day 14
PK parameter of ASP1941 in plasma: Time of the Maximum Concentration (tmax)
Time frame: at Day 1 and Day 14
PK parameter of ASP1941 in urine: Amount excreted in urine between time (Ae)
Time frame: at Day 1 and Day 14
PK parameter of ASP1941 in urine: % of the dose of excreted in urine (Ae%)
Time frame: at Day 1 and Day 14
PK parameter of ASP1941 in plasma and urine: Renal Clearance (CLr)
Time frame: at Day 1 and Day 14
Safety assessed by vital signs
Supine blood pressure and supine pulse rate
Time frame: up to Day 21
Safety assessed by 12-lead electrocardiogram
Time frame: up to Day 21
Safety assessed by laboratory tests
Hematology, biochemistry and urinalysis
Time frame: up to Day 21
Safety assessed by self-monitored blood glucose levels
Time frame: up to Day 21
Safety assessed by Adverse events
Time frame: up to Day 21