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Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MCI-196
Placebo of MCI-196 Tablet
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, anion-exchange resin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MCI-196

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Fasting Plasma Glucose at Baseline
    Change From Baseline in Blood Glucose at Week 12
    Hemoglobin A1c (HbA1c) at Baseline
    Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12

    Secondary Outcome Measures

    Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12

    Full Information

    First Posted
    July 5, 2007
    Last Updated
    June 3, 2012
    Sponsor
    Mitsubishi Tanabe Pharma Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00497198
    Brief Title
    Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes
    Official Title
    An Exploratory Study of MCI-196 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel-Assignment, Placebo-Controlled Manner
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mitsubishi Tanabe Pharma Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes
    Keywords
    Type 2 Diabetes, anion-exchange resin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    183 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MCI-196
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    MCI-196
    Other Intervention Name(s)
    Colestilan(INN), Colestimide(JAN), CHOLEBINE
    Intervention Description
    Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo of MCI-196 Tablet
    Intervention Description
    Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
    Primary Outcome Measure Information:
    Title
    Fasting Plasma Glucose at Baseline
    Time Frame
    0 weeks
    Title
    Change From Baseline in Blood Glucose at Week 12
    Time Frame
    12 weeks (baseline to week 12)
    Title
    Hemoglobin A1c (HbA1c) at Baseline
    Time Frame
    0 weeks
    Title
    Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12
    Time Frame
    12 weeks (baseline to week 12)
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12
    Time Frame
    12 weeks (baseline to week 12)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kazuoki Kondo, MD
    Organizational Affiliation
    Mitsubishi Tanabe Pharma Corporation
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20047620
    Citation
    Kondo K, Kadowaki T. Colestilan monotherapy significantly improves glycaemic control and LDL cholesterol levels in patients with type 2 diabetes: a randomized double-blind placebo-controlled study. Diabetes Obes Metab. 2010 Mar;12(3):246-51. doi: 10.1111/j.1463-1326.2009.01159.x. Epub 2009 Sep 22.
    Results Reference
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    Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes

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