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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: MCI-196; Drug: Placebo of MCI-196 Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00497198

MCI196-19

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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183 participants in 2 patient groups, including a placebo group

MCI-196

Experimental group

Treatment:

Drug: MCI-196

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo of MCI-196 Tablet