NCT01387737

Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,299 (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 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.

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

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

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2011-07-06
• Last updated: 2026-01-08
• Results posted: 2014-04-28

Locations

7 sites across 1 country: Japan