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

June 3, 2012 updated by: Mitsubishi Tanabe Pharma Corporation

An Exploratory Study of MCI-196 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel-Assignment, Placebo-Controlled Manner

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo of MCI-196 Tablet
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting Plasma Glucose at Baseline
Time Frame: 0 weeks
0 weeks
Change From Baseline in Blood Glucose at Week 12
Time Frame: 12 weeks (baseline to week 12)
12 weeks (baseline to week 12)
Hemoglobin A1c (HbA1c) at Baseline
Time Frame: 0 weeks
0 weeks
Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12
Time Frame: 12 weeks (baseline to week 12)
12 weeks (baseline to week 12)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12
Time Frame: 12 weeks (baseline to week 12)
12 weeks (baseline to week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

July 5, 2007

First Submitted That Met QC Criteria

July 5, 2007

First Posted (Estimate)

July 6, 2007

Study Record Updates

Last Update Posted (Estimate)

June 8, 2012

Last Update Submitted That Met QC Criteria

June 3, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCI196-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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