Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

Inclusion Criteria:

• Men or women age ≥20 years old

• Diagnosed with Type 2 diabetes mellitus at least 3 months before screening

• HbA1c of ≥7.0% and ≤10.0% (monotherapy group)

• HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

Exclusion Criteria:

• Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus

• Past or current history of severe diabetic complications

• Fasting plasma glucose > 270 mg/dL before treatment start

• History of hereditary glucose-galactose malabsorption or primary renal glucosuria

• Patients requiring insulin therapy