Efficacy and Safety Study of MCI-196 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:	NCT00497198

Purpose

The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner.　And in addition, the changes in lipid-related parameters are examined.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: MCI-196 Drug: Placebo of MCI-196 Tablet	Phase II

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Exploratory Study of MCI-196 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:

Change in blood glucose and HbA1c from baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Lipid-related parameters from baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Adverse events, adverse drug reactions, laboratory tests and physical data (blood pressure, pulse rate) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	183
Study Start Date:	October 2005
Study Completion Date:	September 2007

Arms	Assigned Interventions
1: Experimental	Drug: MCI-196 Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
2: Placebo Comparator	Drug: Placebo of MCI-196 Tablet Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration

Eligibility

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

Criteria

Inclusion Criteria:

Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL.
Patients whose HbA1c is 7.0% or above during the observation period.

Exclusion Criteria:

Patients with serious cardiac, hepatic or renal complications.
Patients with serious diabetic complications.
Patients with complete biliary obstruction or ileus.
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: NCT00497198

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Director:

Kazuoki Kondo, MD

Mitsubishi Tanabe Pharma Corporation

More Information

Responsible Party:	Mitsubishi Tanabe Pharma Corporation ( General Manager, Clinical Research Department II )
Study ID Numbers:	MCI196-19
Study First Received:	July 5, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00497198
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Type 2 Diabetes
anion-exchange resin

Study placed in the following topic categories:

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

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009