The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks. This study will also assess the safety/efficacy of long-term treatment (52 weeks).
This study consists of two parts. In Part 1, ASP1941 or placebo will be administered orally in a blind manner. In Part 2, the long-term safety and efficacy of ASP1941 will be evaluated in patients who have participated in the study and completed the Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
175
Oral administration once daily
Oral administration once daily
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
Site JP00005
Aichi, Japan
Change from baseline in HbA1c
Time frame: Baseline and Week 24 (end of treatment period 1)
Change from baseline in HbA1c
Time frame: Baseline and up to Week 56
Change from baseline in Fasting plasma glucose
Time frame: Baseline and up to Week 56
Change from baseline in self-monitored blood glucose level
Time frame: Baseline and up to Week 56
Change from baseline in leptin
Time frame: Baseline and up to Week 52
Change from baseline in glycoalbumin
Time frame: Baseline and up to Week 52
Change from baseline in adiponectin
Time frame: Baseline and up to Week 52
Change from baseline in glucagon
Time frame: Baseline and up to Week 52
Change from baseline in number of units of insulin administered concomitantly
Comprehensively assessed by basal insulin daily dose, bolus insulin daily dose and total insulin daily dose.
Time frame: Baseline and up to Week 56
Change from baseline in body weight
Time frame: Baseline and up to Week 56
Change from baseline in waist circumference
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site JP00028
Aichi, Japan
Site JP00003
Chiba, Japan
Site JP00013
Chiba, Japan
Site JP00035
Chiba, Japan
Site JP00022
Fukuoka, Japan
Site JP00023
Fukuoka, Japan
Site JP00031
Fukuoka, Japan
Site JP00002
Gunma, Japan
Site JP00011
Gunma, Japan
...and 26 more locations
Time frame: Baseline and up to Week 52
Safety assessed by incidence of adverse events
Time frame: Up to Week 56
Safety assessed by sitting blood pressure
Time frame: Up to Week 56
Safety assessed by sitting pulse rate
Time frame: Up to Week 56
Safety assessed by standard 12-lead electrocardiogram
Time frame: Up to Week 56
Safety assessed by laboratory tests: Hematology
Time frame: Up to Week 56
Safety assessed by laboratory tests: Biochemistry
Time frame: Up to Week 56
Safety assessed by laboratory tests: Urinalysis
Time frame: Up to Week 56