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Efficacy and Safety Study of MCI-196 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: NCT00497198
Recruitment Status : Completed
First Posted : July 6, 2007
Results First Posted : August 11, 2011
Last Update Posted : June 8, 2012
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: MCI-196 Drug: Placebo of MCI-196 Tablet Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory Study of MCI-196 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel-Assignment, Placebo-Controlled Manner
Study Start Date : October 2005
Actual Study Completion Date : September 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MCI-196 Drug: MCI-196
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
Other Names:
  • Colestilan(INN)
  • Colestimide(JAN)
  • CHOLEBINE
Placebo Comparator: Placebo Drug: Placebo of MCI-196 Tablet
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration


Outcome Measures
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Primary Outcome Measures :
  1. Fasting Plasma Glucose at Baseline [ Time Frame: 0 weeks ]
  2. Change From Baseline in Blood Glucose at Week 12 [ Time Frame: 12 weeks (baseline to week 12) ]
  3. Hemoglobin A1c (HbA1c) at Baseline [ Time Frame: 0 weeks ]
  4. Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 [ Time Frame: 12 weeks (baseline to week 12) ]

Secondary Outcome Measures :
  1. Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 [ Time Frame: 12 weeks (baseline to week 12) ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00497198


Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
More Information
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Publications of Results:

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Responsible Party: General Manager, Clinical Research Department II, Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00497198    
Other Study ID Numbers: MCI196-19
First Posted: July 6, 2007    Key Record Dates
Results First Posted: August 11, 2011
Last Update Posted: June 8, 2012
Last Verified: June 2012
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Type 2 Diabetes
anion-exchange resin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Bile Acids and Salts
Gastrointestinal Agents