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

NCT00497198 | Completed Phase 2 Results

• 1 other identifier: MCI196-19
• Study Type: interventional
• Target: 183
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; anion-exchange resin

Outcome Measures

Primary Outcomes (4)

• Fasting Plasma Glucose at Baseline

  0 weeks

• Change From Baseline in Blood Glucose at Week 12

  12 weeks (baseline to week 12)

• Hemoglobin A1c (HbA1c) at Baseline

  0 weeks

• Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12

  12 weeks (baseline to week 12)

Secondary Outcomes (1)

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

  12 weeks (baseline to week 12)

Study Arms (2)

MCI-196

EXPERIMENTAL

Drug: MCI-196

Placebo

PLACEBO COMPARATOR

Drug: Placebo of MCI-196 Tablet

Interventions

MCI-196 DRUG

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

Also known as: Colestilan(INN), Colestimide(JAN), CHOLEBINE

MCI-196

Placebo of MCI-196 Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Related Publications (1)

• 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.

  PMID: 20047620 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

cholebine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Kazuoki Kondo, MD

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 6, 2007
• Study Start: October 1, 2005
• Study Completion: September 1, 2007
• Last Updated: January 6, 2026
• Results First Posted: August 11, 2011

Record last verified: 2025-12