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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: MCI-196; Drug: Placebo of MCI-196 Tablet

• Registration Number: NCT00497198
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-07-05
• Study First Submitted QC: 2007-07-05
• Study First Posted: 2007-07-06
• Study Completion: 2007-09
• Results First Submitted: 2011-07-14
• Results First Submitted QC: 2011-07-15
• Results First Posted: 2011-08-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-03
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCI-196	MCI-196	-
Placebo	Placebo of MCI-196 Tablet	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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