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An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes

2014-08-27 03:17:39 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Type 2 Diabetes Mellitus

Intervention

TA-7284-Low, TA-7284-Low-middle, TA-7284-High-middle, TA-7284-High, Placebo

Location

Research site
Chugoku
Japan

Status

Recruiting

Source

Mitsubishi Tanabe Pharma Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:39-0400

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