Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

Sponsor
Tanabe Pharma Corporation
Study ID
NCT02220920
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin (TA-7284) — DRUG
    The patients will receive Canagliflozin orally for 16 weeks
  • Placebo — DRUG
    The patients will receive Placebo orally for 16 weeks
  • Insulin — DRUG

Study Details

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.

Key Dates

Start date
Aug 31, 2014
Status verified
Dec 2025
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: Canagliflozin (TA-7284) ＋insulin
  • Placebo Comparator: Placebo＋insulin

Primary Outcome Measure

Change in HbA1c From Baseline [ Time Frame: baseline and Week 16 ]

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