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Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
Type 2 Diabetes Mellitus
Drug: TA-7284-LowDrug: TA-7284-High
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.
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Ages Eligible for Study:
20 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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