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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01072331
First received: February 18, 2010
Last updated: April 2, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in 24-h Mean Glucose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 18, 2010
Results First Received: November 20, 2012
Last Updated: April 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 01, 2014