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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072331
First Posted: February 22, 2010
Last Update Posted: April 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: MP-513 Drug: Placebo of MP-513 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetic/Pharmacodynamic Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) [ Time Frame: 4 weeks ]
  • Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Change From Baseline in 24-h Mean Glucose [ Time Frame: 4 weeks ]
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: 4 weeks ]

Enrollment: 99
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-513 10 mg, once a day, for 4 weeks Drug: MP-513
MP-513 10 mg, once a day, for 4 weeks
Experimental: MP-513 20 mg, once a day, for 4 weeks Drug: MP-513
MP-513 20 mg, once a day, for 4 weeks
Placebo Comparator: Placebo of MP-513 Drug: Placebo of MP-513
MP-513 placebo, once a day, for 4 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072331


Locations
Japan
Suita, Osaka, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
Study Director: Tadashi Yoshida, MD Mitsubishi Tanabe Pharma Corporation
  More Information

Publications:
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01072331     History of Changes
Other Study ID Numbers: 3000-A12
First Submitted: February 18, 2010
First Posted: February 22, 2010
Results First Submitted: November 20, 2012
Results First Posted: December 19, 2012
Last Update Posted: April 9, 2013
Last Verified: April 2013

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases