This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.
This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on Nateglinide alone more than 4 weeks. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
122
oral
oral
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kantou, Japan
Unnamed facility
Kyushu, Japan
Unnamed facility
Tōhoku, Japan
change from baseline in hemoglobin A1c (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
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