The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.
This study consists of two parts. First part is a placebo-controlled multicenter, double-blind, parallel group study, in which subjects will receive ipragliflozin or placebo once daily in combination with an insulin preparation for 16 weeks. Second part is a multicenter, open-label period (36 weeks) with no placebo group. The dose of ipragliflozin can be doubled in combination with an insulin preparation during the second part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
262
oral
oral
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Change in HbA1C from baseline
Time frame: Baseline and Week 16
Fasting plasma glucose
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Leptin concentration
Time frame: Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52
Fructosamine concentration
Time frame: Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52
Adiponectin concentration
Time frame: Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52
Body weight
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Waist circumference
Time frame: Baseline, Week 16, 24, 52
Blood glucose values of self monitoring
written in a diary
Time frame: Baseline, Week 8, 16, 24, 52
Safety assessed by the adverse events, vital signs. and laboratory tests
Time frame: Up to 52 Weeks
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Unnamed facility
Kyushu, Japan
Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan