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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Mitsubishi Tanabe Pharma Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 29, 2014