Monotherapy Study of MP-513 in Patients With Type 2 Diabetes

Tanabe Pharma Corporation203 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

203

Conditions

Type 2 Diabetes Mellitus

Interventions

Teneligliptin 20 mgDRUG

PlaceboDRUG

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% - 10.0% * Patients who were not administered diabetes therapeutic drugs 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 with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification * 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

Locations (1)

Unnamed facility

Sapporo, Hokkaido, 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: 12 weeks

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: 12 weeks

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: 12 weeks

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: 12 weeks

Data from ClinicalTrials.gov

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