Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00628212

Purpose

The purpose of this study is to evaluate the safety and efficacy and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: MP-513 Drug: Placebo of MP-513	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Confirmatory Study of MP-513 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel Assignment, Placebo-Controlled Manner

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

Changes in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood glucose, Immuno Reactive Insulin (IRI), Glucagon, etc. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Adverse events, laboratory tests, vital signs, etc. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	January 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MP-513(L): Experimental	Drug: MP-513 Two tablets of MP-513 tablet once a day, 12 weeks administration
MP-513(M): Experimental	Drug: MP-513 Two tablets of MP-513 tablet once a day, 12 weeks administration
MP-513(H): Experimental	Drug: MP-513 Two tablets of MP-513 tablet once a day, 12 weeks administration
Placebo of MP-513: Placebo Comparator	Drug: Placebo of MP-513 Two tablets of placebo tablet once a day, 12 weeks administration

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 6.5 - 9.5%
Patients who were not administered 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 failure, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients with Class III/IV heart failure symptoms according to NYHA functional classification
Patients with serious diabetic complications
Patients who are the excessive alcohol addicts
Patients with severe hepatic disorder or severe renal disorder.
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: NCT00628212

Locations

Japan, Shizuoka-ken
SURUGA Clinic
Shizuoka-shi, Shizuoka-ken, Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Director:	Takashi Kadowaki, Professor, MD,PhD	The University of Tokyo
Study Director:	Kazuoki Kondo, MD	Mitsubishi Tanabe Pharma Corporation
Study Director:	Tadashi Yoshida, MD	Mitsubishi Tanabe Pharma Corporation

More Information

Responsible Party:	Mitsubishi Tanabe Pharma Corporation ( General Manager, Clinical Research Department II )
Study ID Numbers:	3000-A4
Study First Received:	February 24, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00628212
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

insulin resistance

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 16, 2009