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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Bile Acids and Salts

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.