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

Sponsor
Tanabe Pharma Corporation
Study ID
NCT02622113
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)

Key Dates

Start date
Dec 31, 2014
Status verified
Dec 2025
Primary completion
Apr 30, 2016
Completion
Apr 30, 2016

Study Design

Enrollment
139 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin (TA-7284) ＋insulin

Primary Outcome Measure

Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) [ Time Frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks ]

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