Status:

COMPLETED

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

Lead Sponsor:

Tanabe Pharma Corporation

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

20+ years

Phase:

PHASE3

Brief 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 d...

Eligibility Criteria

Inclusion

  • Men or women age ≥20 years old
  • Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period
  • HbA1c of ≥7.0% and ≤10.0%

Exclusion

  • Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
  • Past or current history of severe diabetic complications
  • Fasting plasma glucose \> 270 mg/dL before treatment start
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients requiring insulin therapy

Key Trial Info

Start Date :

July 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2012

Estimated Enrollment :

272 Patients enrolled

Trial Details

Trial ID

NCT01413204

Start Date

July 1 2011

End Date

August 1 2012

Last Update

January 8 2026

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Reserch site

Chūbu, Japan

2

Reserch site

Kanto, Japan

3

Reserch site

Kinki, Japan

4

Reserch site

Shikoku, Japan