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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo and Metformin; Drug: MP-513 Lowest Dose and Metformin; Drug: MP-513 Medium Dose and Metformin; Drug: MP-513 Low Dose and Metformin; Drug: MP-513 High Dose and Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00971243

MP-513-E07

Details and patient eligibility

About

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.

Enrollment: 448 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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448 participants in 5 patient groups, including a placebo group

MP-513 Lowest Dose and Metformin

Experimental group

Treatment:

Drug: MP-513 Lowest Dose and Metformin

MP-513 Low Dose and Metformin

Experimental group

Treatment:

Drug: MP-513 Low Dose and Metformin

MP-513 Medium Dose and Metformin

Experimental group

Treatment:

Drug: MP-513 Medium Dose and Metformin

MP-513 High Dose and Metformin

Experimental group

Treatment:

Drug: MP-513 High Dose and Metformin

Placebo and Metformin

Placebo Comparator group

Treatment:

Drug: Placebo and Metformin