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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01026194
First received: December 2, 2009
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: MP-513 and thiazolidinedione
Drug: Placebo of MP-513 and thiazolidinedione
 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: A Phase III Study of MP-513 in Combination With Thiazolidinedione in Japanese Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: Weeks 12, 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Blood glucose [ Time Frame: Weeks 12, 52 ] [ Designated as safety issue: No ]
  • Change from baseline in Imuno Reactive Insulin (IRI) [ Time Frame: Weeks 12, 52 ] [ Designated as safety issue: No ]
  • Change from baseline in Glucagon [ Time Frame: Weeks 12, 52 ] [ Designated as safety issue: No ]
  • Adverse events, laboratory tests, physical data. [ Time Frame: Weeks 12, 52 ] [ Designated as safety issue: Yes ]

Enrollment: 202
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-513 and thiazolidinedione Drug: MP-513 and thiazolidinedione
MP-513, tablets, once a day and thiazolidinedione, tablets, once a day for up to 12 weeks and extension treatment for up to 52 weeks.
Placebo Comparator: Placebo of MP-513 and thiazolidinedione Drug: Placebo of MP-513 and thiazolidinedione

Placebo, tablets, once a day and thiazolidinedione, tablets, once a day for up to 12 weeks.

MP-513, tablets, once a day and thiazolidinedione, tablets, once a day after 12 weeks administration of investigational drug for up to 52 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 12 weeks before administration of investigational drug
  • Patients whose HbA1c is between 6.5% and 10.0%
  • Patients who took Thiazolidinedione for diabetes over 16 weeks before administration of investigational drug
  • Patients who were not administered diabetes therapeutic 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 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: NCT01026194

Locations
Japan
Shinjukuku, Tokyo, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Takashi Kadowaki, Professor Tokyo University
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: NCT01026194     History of Changes
Other Study ID Numbers: 3000-A7
Study First Received: December 2, 2009
Last Updated: February 27, 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
 2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013