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
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 April 17, 2014