Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

Phase 3

Completed

Interventions: Drug: teneligliptin
Drug: glinide
Drug: alpha-glucosidase inhibitor
Drug: biguanide

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is between 6.5% - 10.0%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion Criteria

Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients who are accepting treatments of arrhythmias
Patients with serious diabetic complications
Patients who are habitual excessive alcohol consumption.
Patients with severe hepatic disorder or severe renal disorder.
Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Arm && Interventions

Group	Intervention	Description
teneligliptin	teneligliptin	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
teneligliptin and glinide	teneligliptin	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
teneligliptin and glinide	glinide	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
teneligliptin and biguanide	teneligliptin	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
teneligliptin and alpha-glucosidase inhibitor	alpha-glucosidase inhibitor	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
teneligliptin and biguanide	biguanide	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
teneligliptin and alpha-glucosidase inhibitor	teneligliptin	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	52 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose at Week 52	Baseline and 52 weeks
Change From Baseline in Fasting Glucagon at Week 52	Baseline and 52 weeks
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52	Baseline and 52 weeks
Change From Baseline in HbA1c at Week 52	Baseline and 52 weeks