Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284 JNJ-28431754 Canagliflozin Type 2 diabetes mellitus Sodium Glucose Co-transporter (SGLT2 inhibitor)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 383
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.

Detailed description:
Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of T2DM and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, placebo-controlled, parallel-group study to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with T2DM, who are not optimally controlled on diet and exercise. The primary study hypothesis is that the study drug will be superior to placebo as assessed by the change in HbA1c from baseline. The patients will receive tablets of TA-7284, or placebo, once daily for 12 weeks.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: TA-7284-Low intervention 2: TA-7284-Low-middle intervention 3: TA-7284-High-middle intervention 4: TA-7284-High intervention 5: Placebo
Intervention descriptions: intervention 1: TA-7284-Low intervention 2: TA-7284-Low-middle intervention 3: TA-7284-High-middle intervention 4: TA-7284-High intervention 5: Placebo

Protocol document: