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Long-term 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:
NCT01301833
First received: February 14, 2011
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of MP-513 as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent 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:
  • Number of participants with adverse events [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in HbA1c [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in Blood glucose [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in Glucagon [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in Immuno Reactive Insulin (IRI) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 462
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-513, tablets, once a day for up to 52 weeks.
MP-513, tablets, once a day for up to 52 weeks.
 Drug: MP-513
MP-513, tablets, once a day for up to 52 weeks.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent(biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
  • 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 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: NCT01301833

Locations
Japan
Chitose-shi, Hokkaidou, 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
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01301833     History of Changes
Other Study ID Numbers: 3000-A14
Study First Received: February 14, 2011
Last Updated: November 7, 2012
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013