Text Size

Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00628212
First received: February 24, 2008
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.


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

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: A Phase II, Double-Blind, Placebo-Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus -Confirmative Study-

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Changes in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood glucose, Immuno Reactive Insulin (IRI), Glucagon, etc. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events, laboratory tests, vital signs, etc. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 324
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-513(L) Drug: MP-513
Two tablets of MP-513 tablet once a day, 12 weeks administration
Experimental: MP-513(M) Drug: MP-513
Two tablets of MP-513 tablet once a day, 12 weeks administration
Experimental: MP-513(H) Drug: MP-513
Two tablets of MP-513 tablet once a day, 12 weeks administration
Placebo Comparator: Placebo of MP-513 Drug: Placebo of MP-513
Two tablets of placebo tablet once a day, 12 weeks administration

  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 12 weeks before administration of investigational drug
  • Patients whose HbA1c is 6.5 - 9.5%
  • Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

  • Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
  • Patients with Class III/IV heart failure symptoms according to NYHA functional classification
  • Patients with serious diabetic complications
  • Patients who are the excessive alcohol addicts
  • Patients with severe hepatic disorder or severe renal disorder.
  • 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: NCT00628212

Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Takashi Kadowaki, Professor, MD,PhD The University of Tokyo
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
Study Director: Tadashi Yoshida, MD Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00628212     History of Changes
Other Study ID Numbers: 3000-A4
Study First Received: February 24, 2008
Last Updated: March 25, 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 May 23, 2013