Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
Status and phase
Conditions
Treatments
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
Sex
Ages
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
Allocation
Interventional model
Masking
1,299 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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