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.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
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