Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)

Sponsor
Tanabe Pharma Corporation
Study ID
NCT02354235
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.

Key Dates

Start date
Jan 31, 2015
Status verified
Dec 2025
Primary completion
Jan 31, 2016
Completion
Jan 31, 2016

Study Design

Enrollment
138 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin + Teneligliptin
    Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.
  • Placebo Comparator: Placebo + Teneligliptin
    Patients receive placebo for 24 weeks in combination with Teneligliptin.

Primary Outcome Measure

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) [ Time Frame: Baseline, 24 Weeks ]

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