This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus.
This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
243
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Change from baseline in HbA1c
Time frame: Baseline and for 24 weeks
Change from baseline in fasting plasma glucose
Time frame: Baseline and for 24 weeks
Change from baseline in fasting serum insulin
Time frame: Baseline and for 24 weeks
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
Time frame: for 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Kyushu, Japan
Unnamed facility
Tōhoku, Japan