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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MCI-196

Group Type EXPERIMENTAL

MCI-196

Intervention Type DRUG

Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo of MCI-196 Tablet

Intervention Type DRUG

Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration

Interventions

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MCI-196

Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)

Intervention Type DRUG

Placebo of MCI-196 Tablet

Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration

Intervention Type DRUG

Other Intervention Names

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Colestilan(INN) Colestimide(JAN) CHOLEBINE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No