NCT01413204

Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TA-7284 as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

Detailed description

This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	TA-7284 Low	The patients will receive TA-7284-Low orally for 24 weeks.
DRUG	TA-7284 High	The patients will receive TA-7284-High orally for 24 weeks.
DRUG	Placebo	The patients will receive Placebo orally for 24 weeks.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-08-10
• Last updated: 2026-01-08
• Results posted: 2014-06-05

Locations

5 sites across 1 country: Japan