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Trial record 1 of 1 for:    NCT00971243
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Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00971243
First received: September 1, 2009
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: MP-513 Lowest Dose and Metformin
Drug: MP-513 Low Dose and Metformin
Drug: MP-513 Medium Dose and Metformin
Drug: MP-513 High Dose and Metformin
Drug: Placebo and Metformin
 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 IIb, Double-blind, Parallel Group, Multi-center, Dose-finding Study to Investigate the Efficacy and Safety of 4 Doses of MP-513 When Added to Ongoing Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus, With an Open Label Extension

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 24, 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood glucose, Insulin, Glucagon, HOMA-β, HOMA-IR, BMI, Lipids, etc. [ Time Frame: Weeks 24, 52 ] [ Designated as safety issue: No ]
  • Adverse events, laboratory tests, vital signs, etc. [ Time Frame: Weeks 24, 52 ] [ Designated as safety issue: Yes ]

Enrollment: 448
Study Start Date: August 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-513 Lowest Dose and Metformin Drug: MP-513 Lowest Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Experimental: MP-513 Low Dose and Metformin Drug: MP-513 Low Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Experimental: MP-513 Medium Dose and Metformin Drug: MP-513 Medium Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Experimental: MP-513 High Dose and Metformin Drug: MP-513 High Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Placebo Comparator: Placebo and Metformin Drug: Placebo and Metformin
Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are aged ≧ 18 years old.
  • Patients whose HbA1c is ≧ 7.0 % and ＜ 10.0%.
  • Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡.
  • Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.

Exclusion Criteria:

  • Patients with type 1 diabetes or secondary form of diabetes.
  • Patients with heart failure symptoms.
  • Patients with serious diabetic complications.
  • Patients with severe hepatic disorder or severe renal disorder.
  • Patients who are the excessive alcohol addicts.
  • 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: NCT00971243

  Show 45 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Principal Investigator: David Kerr, Dr Royal Bournemouth Hospital
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00971243     History of Changes
Other Study ID Numbers: MP-513-E07
Study First Received: September 1, 2009
Last Updated: December 15, 2011
Health Authority: Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013