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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: TA-7284-High; Drug: TA-7284-Low

Study type: Interventional

Funder types: Industry

Identifiers

NCT01387737

TA-7284-06

Details and patient eligibility

About

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.

Full description

This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Enrollment: 1,299 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,299 participants in 2 patient groups

TA-7284-Low

Experimental group

Treatment:

Drug: TA-7284-Low

TA-7284-High

Experimental group

Treatment:

Drug: TA-7284-High