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NCT Number: NCT01072331

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Suita, Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MP-513

Drug

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

Placebo of MP-513

Drug

MP-513 placebo, once a day, for 4 weeks

Primary outcomes

  1. Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)

    Time frame: 4 weeks

  2. Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)

    Time frame: 4 weeks

Secondary outcomes

  1. Change From Baseline in 24-h Mean Glucose

    Time frame: 4 weeks

  2. Change From Baseline in Fasting Plasma Glucose

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 22, 2010
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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