NCT01022112

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally-Administered SGLT2 Inhibitor TA-7284

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	TA-7284-Low	TA-7284-Low
DRUG	TA-7284-Low-middle	TA-7284-Low-middle
DRUG	TA-7284-High-middle	TA-7284-High-middle
DRUG	TA-7284-High	TA-7284-High
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-12-01
• Last updated: 2026-01-08
• Results posted: 2014-06-05

Locations

6 sites across 1 country: Japan