Status:

COMPLETED

Long-Term Safety Study of MT-2412 in Japanese 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 safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 dia...

Eligibility Criteria

Inclusion

  • Men or women age ≥20 years old
  • HbA1c of ≥7.0% and \<10.5%
  • FPG of ≤ 270 mg/dL
  • Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period

Exclusion

  • Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
  • Patients with serious diabetic complications
  • Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
  • Patients with severe hepatic disorder or severe renal disorder.

Key Trial Info

Start Date :

August 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2016

Estimated Enrollment :

153 Patients enrolled

Trial Details

Trial ID

NCT02220907

Start Date

August 1 2014

End Date

February 1 2016

Last Update

January 7 2026

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Research site

Chugoku, Japan

2

Research site

Chūbu, Japan

3

Research site

Hokkaido, Japan

4

Research site

Kanto, Japan