Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes

Tanabe Pharma Corporation204 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

204

Conditions

Type 2 Diabetes Mellitus

Interventions

Placebo / Teneli (Teneligliptin) + pio (pioglitazone)DRUG

Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.

Teneli / Teneli + pioDRUG

Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are 20 - 75 years old * 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% and 10.0% * Patients who took Thiazolidinedione for diabetes over 16 weeks before administration of investigational drug * 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

Locations (1)

Unnamed facility

Shinjukuku, Tokyo, Japan

Outcomes

Primary Outcomes

Change From Baseline in HbA1c at Week 12

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 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

Time frame: at Week 0 and Week 12

Secondary Outcomes

Change From Baseline in Fasting Plasma Glucose at Week 12

The change from Baseline in Fasting Plasma Glucose collected at Week 12. 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.

Time frame: at Week 0 and Week 12

Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12

The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. 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.

Time frame: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12

Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12

The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. 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.

Time frame: at Week 0 and Week 12

Data from ClinicalTrials.gov

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