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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00971243
Recruitment Status : Completed
First Posted : September 3, 2009
Results First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]
    The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.


Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]
    Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.

  2. Adverse Events, Laboratory Tests, Vital Signs, Etc. [ Time Frame: Weeks 24, 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971243


Locations
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Denmark
Aalborg, Denmark
Ballerup, Denmark
Vejle, Denmark
Germany
Falkensee, Germany
Hamburg, Germany
Karlsruhe, Germany
Kiel, Germany
Ludwigshafen, Germany
Lübeck, Germany
Mainz, Germany
Hungary
Budapest, Hungary
Békéscsaba, Hungary
Gyöngyös, Hungary
Kaposvár, Hungary
Miskolc, Hungary
Nyíregyháza, Hungary
Semmelweis, Hungary
Szentes, Hungary
Szigetvár, Hungary
Ádám, Hungary
Lithuania
Kaunas, Lithuania
Klaipeda, Lithuania
Vilnius, Lithuania
Poland
Gdansk, Poland
Krakow, Poland
Leszno, Poland
Lodz, Poland
Niemodlin, Poland
Plock, Poland
Warszawa, Poland
Wroclaw, Poland
Romania
Brasov, Romania
Bucharest, Romania
Bucuresti, Romania
Galati, Romania
Ploiesti, Romania
Timisoara, Romania
Timis, Romania
United Kingdom
Addlestone, United Kingdom
Ayr, United Kingdom
Bournemouth, United Kingdom
East Sussex, United Kingdom
Edinburgh, United Kingdom
Oldham, United Kingdom
York, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Principal Investigator: David Kerr, Dr Royal Bournemouth Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00971243    
Other Study ID Numbers: MP-513-E07
First Posted: September 3, 2009    Key Record Dates
Results First Posted: September 1, 2014
Last Update Posted: September 1, 2014
Last Verified: August 2014
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Insulin resistance
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs