This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.
Subjects will undergo the 6-week screening period before entering the 24-week treatment period and will receive ASP1941 before breakfast during the treatment period. All subjects will be followed for 4 weeks after study treatment is discontinued.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
174
oral
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Unnamed facility
Kyushu, Japan
Change in HbA1c
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in fasting plasma glucose
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in fasting serum insulin
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in waist circumference
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in body weight
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in urine glucose
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan