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
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 April 15, 2014