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

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00497198
First received: July 5, 2007
Last updated: June 3, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: MCI-196
Drug: Placebo of MCI-196 Tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory Study of MCI-196 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel-Assignment, Placebo-Controlled Manner

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Fasting Plasma Glucose at Baseline [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Blood Glucose at Week 12 [ Time Frame: 12 weeks (baseline to week 12) ] [ Designated as safety issue: No ]
  • Hemoglobin A1c (HbA1c) at Baseline [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 [ Time Frame: 12 weeks (baseline to week 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 [ Time Frame: 12 weeks (baseline to week 12) ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: October 2005
Study Completion Date: September 2007
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo of MCI-196 Tablet
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497198

Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
  More Information

Publications:
Responsible Party: General Manager, Clinical Research Department II, Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00497198     History of Changes
Other Study ID Numbers: MCI196-19
Study First Received: July 5, 2007
Results First Received: July 14, 2011
Last Updated: June 3, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Type 2 Diabetes
anion-exchange resin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014