Primary Objective: To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29. Secondary Objectives: To demonstrate: * Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast * Delaying gastric emptying (13C-acetic acid breath test) * Safety and tolerability
The duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances. 13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:solution Route of administration: subcutaneous
Investigational Site Number 392-107
Atsugi-shi, Japan
Investigational Site Number 392-125
Chiyoda-ku, Japan
Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast
Time frame: Day 29 after first intake of investigational product
Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast
Time frame: Day 29 after first intake of investigational product
Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast
Time frame: Day 29 after first intake of investigational product
Change from baseline in glucagon levels at Day 29 after a standardized breakfast
Time frame: Day 29 after first intake of investigational product
Change in gastric emptying half life (13C-acetic acid breath test)
Time frame: Day 29 after first intake of investigational product
Proportion of patients with adverse events
Time frame: Up to Day 33 from the first intake of investigational medicinal product
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number 392-121
Chuoh-ku, Japan
Investigational Site Number 392-102
Ichihara-shi, Japan
Investigational Site Number 392-103
Kawaguchi-shi, Japan
Investigational Site Number 392-114
Kitamoto-shi, Japan
Investigational Site Number 392-122
Kobe, Japan
Investigational Site Number 392-126
Kumamoto, Japan
Investigational Site Number 392-127
Kumamoto, Japan
Investigational Site Number 392-101
Kyoto, Japan
...and 10 more locations