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

Tanabe Pharma Corporation448 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

448

Conditions

Type 2 Diabetes Mellitus

Interventions

MP-513 Lowest Dose and MetforminDRUG

MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

MP-513 Low Dose and MetforminDRUG

MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

MP-513 Medium Dose and MetforminDRUG

MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are aged ≧ 18 years old. * Patients whose HbA1c is ≧ 7.0 % and \< 10.0%. * Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡. * Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit. Exclusion Criteria: * Patients with type 1 diabetes or secondary form of diabetes. * Patients with heart failure symptoms. * Patients with serious diabetic complications. * Patients with severe hepatic disorder or severe renal disorder. * Patients who are the excessive alcohol addicts. * Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception.

Locations (44)

Unnamed facility

Outcomes

Primary Outcomes

Change in HbA1c From Baseline to Week 24

The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.

Time frame: Baseline and Week 24

Secondary Outcomes

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24

Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.

Time frame: Baseline and Week 24

Adverse Events, Laboratory Tests, Vital Signs, Etc.

Time frame: Weeks 24, 52

Data from ClinicalTrials.gov

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