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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497198
• Other study ID #: MCI196-19
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2007
• Last updated: June 3, 2012
• Start date: October 2005
• Est. completion date: September 2007

Study information

• Verified date: June 2012
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• MCI-196
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 Tablet
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

References & 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose at Baseline		0 weeks	No
Primary	Change From Baseline in Blood Glucose at Week 12		12 weeks (baseline to week 12)	No
Primary	Hemoglobin A1c (HbA1c) at Baseline		0 weeks	No
Primary	Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12		12 weeks (baseline to week 12)	No
Secondary	Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12		12 weeks (baseline to week 12)	No