Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes

Phase 4

Completed

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an extension treatment for up to 52 weeks.

Recruitment & Eligibility

Inclusion Criteria

Patients who has been receiving a stable dose and regimen of insulin 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 7.5% and 10.5%
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 the excessive alcohol addicts
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
Placebo/Teneli (Teneligliptin) + insulin	Insulin	Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.
Teneli (Teneligliptin) /Teneli + insulin	Teneli (Teneligliptin)	Teneligliptin for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.
Placebo/Teneli (Teneligliptin) + insulin	Teneli (Teneligliptin)	Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.
Placebo/Teneli (Teneligliptin) + insulin	Placebo	Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.
Teneli (Teneligliptin) /Teneli + insulin	Insulin	Teneligliptin for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c	at Week 0 and Week 16	The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose	at Week 0 and Week 16	The change from Baseline in Fasting Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose	0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16	The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.
Change From Baseline in 2-hour Postprandial Plasma Glucose	at Week 0 and Week 16	The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.