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

A Phase 2 study testing MCI-196 in people with Type 2 Diabetes, run by Tanabe Pharma Corporation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: MCI-196
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 183 participants
Where: No sites listed yet
Study dates: Oct 2005to Sep 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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

Conditions: Type 2 Diabetes
Being tested: MCI-196, Placebo of MCI-196 Tablet
Keywords: Type 2 Diabetes, anion-exchange resin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MCI-196Drug
Also called Colestilan(INN), Colestimide(JAN), CHOLEBINE
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
Placebo of MCI-196 TabletDrug
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration

Study groups in NCT00497198
Study group	Role	What they receive
MCI-196	Experimental	Not described Receives: Drug: MCI-196
Placebo	Placebo comparator	Not described Receives: Drug: Placebo of MCI-196 Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Sep 2007

First posted6 Jul 2007 (estimated)
Study startOct 2005
Study completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00497198
Sponsor's protocol ID: MCI196-19
Status last verified: Dec 2025
First submitted: 5 Jul 2007
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 20047620

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study of MCI-196 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel-Assignment, Placebo-Controlled Manner
ClinicalTrials.gov ID: NCT00497198
Acronym / sponsor ID: MCI196-19
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes, anion-exchange resin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Oct 2005
Study completion: Sep 2007 (actual)
First posted: 6 Jul 2007 (estimated)
Results: Posted 11 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MCI-196	Experimental	Drug: MCI-196
Placebo	Placebo comparator	Drug: Placebo of MCI-196 Tablet

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MCI-196Also: Colestilan(INN), Colestimide(JAN), CHOLEBINEThree tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)	Drug	MCI-196
Placebo of MCI-196 TabletThree tablets of Placebo tablet at a time, three times daily, 12 weeks administration	Drug	Placebo

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 11 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MCI-196	92	87
Placebo	91	86

Primary outcome: Fasting Plasma Glucose at Baseline

Time frame: 0 weeks. Mean (Standard Deviation). Unit: mg/dL

Measure	MCI-196 n = 86	Placebo n = 86
Value	170.2 (21.1)	168.2 (20.5)

Population analysed: Per protocol set

Primary outcome: Change From Baseline in Blood Glucose at Week 12

Time frame: 12 weeks (baseline to week 12). Mean (Standard Error). Unit: mg/dL

Measure	MCI-196 n = 86	Placebo n = 86
Value	-21.3 (2.2)	0.8 (2.2)

Population analysed: Per protocol set; Last observation carried forward

Primary outcome: Hemoglobin A1c (HbA1c) at Baseline

Time frame: 0 weeks. Mean (Standard Deviation). Unit: percentage

Measure	MCI-196 n = 86	Placebo n = 86
Value	7.97 (0.72)	7.94 (0.77)

Population analysed: Per protocol set

Primary outcome: Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12

Time frame: 12 weeks (baseline to week 12). Mean (Standard Error). Unit: percentage

Measure	MCI-196 n = 86	Placebo n = 86
Value	-0.70 (0.06)	0.18 (0.06)

Population analysed: Per protocol set; Last observation carried forward

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MCI-196	1 of 92 (1.1%)	53 of 92 (57.6%)	Not reported
Placebo	5 of 91 (5.5%)	46 of 91 (50.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20047620Kondo 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.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kazuoki Kondo, MD study director

Tanabe Pharma Corporation

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MCI-196 in people with Type 2 Diabetes, run by Tanabe Pharma Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Plasma Glucose at Baseline (time frame: 0 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00497198, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.