Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)

Tanabe Pharma Corporation154 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

154

Conditions

Type 2 Diabetes Mellitus

Interventions

CanagliflozinDRUG

TeneligliptinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women who are 20 - 75 years old * HbA1c of ≥7.0% and \<10.5% * FPG of ≤ 270 mg/dL * Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before run-in period Exclusion Criteria: * Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes * Patients with serious diabetic complications * Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria * Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification * Patients with severe hepatic disorder or severe renal disorder.

Locations (3)

Reserch site

Kanto, Japan

Reserch site

Kinki, Japan

Reserch site

Tōhoku, Japan

Outcomes

Primary Outcomes

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)

The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.

Time frame: Baseline, 24 Weeks

Secondary Outcomes

Change From Baseline in Fasting Plasma Glucose Level

The change from baseline in fasting plasma glucose level collected at Week 24.

Time frame: Baseline, 24 Weeks

Percentage Change in Body Weight From Baseline

The percentage change from baseline in body weight collected at Week 24.

Time frame: Baseline, 24 Weeks

Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)

The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.

Time frame: 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks

Change From Baseline in 2-hour Postprandial Plasma Glucose Level

The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.

Time frame: 2 Hours Postprandial, at Baseline and 24 Weeks

Data from ClinicalTrials.gov

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