An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.

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

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

Inclusion Criteria:

• Aged from 20 to 80 years inclusive on the day of informed consent;

• Patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;

• Patients with HbA1c of ≥6.5% and ≤9.5% (according to the Japan Diabetic Society [JDS] criteria) on the start day of the run-in period;

Exclusion Criteria:

• Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);

• Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);

• Fasting blood glucose of >270 mg/dL on the start day of the run-in period or at Week 2 of the run-in period;

• eGFR of <60 mL/min/1.73 m2 on the start day of the run-in period;

• Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;

• History of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period;

• Concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease;

• Past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor.

• Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;

• Pregnant women, lactating mothers, or women of childbearing potential;

• Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).