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Completed

NCT Number: NCT00497198

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

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MCI-196

Drug

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 of MCI-196 Tablet

Drug

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

Primary outcomes

  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 outcomes

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

    Time frame: 12 weeks (baseline to week 12)

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Jul 6, 2007
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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