The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
462
Unnamed facility
Chitose-shi, Hokkaido, Japan
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Time frame: 52 Weeks
Change From Baseline in HbA1c at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Plasma Glucose at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Glucagon at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
Time frame: Baseline and 52 weeks
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