Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo of MP-513; Drug: MP-513

Study type: Interventional

Funder types: Industry

Identifiers

NCT01072331

3000-A12

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.

Enrollment: 99 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are 20 - 75 years old
• Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug
• Patients whose HbA1c is ≥6.5% and <10.0%
• Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

MP-513 10 mg, once a day, for 4 weeks

Experimental group

Treatment:

Drug: MP-513

Drug: MP-513

MP-513 20 mg, once a day, for 4 weeks

Experimental group

Treatment:

Drug: MP-513

Drug: MP-513

Placebo of MP-513

Placebo Comparator group

Treatment:

Drug: Placebo of MP-513