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KMID : 1200020170410020135
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Diabetes & Metabolism Journal
2017 Volume.41 No. 2 p.135 ~ p.145
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Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial
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Min Kyung-Wan
Ku Bon-Jeong
Lee Ji-Hyun
Kim Min-Seon
Ahn Kyu-Jeung
Lee Moon-Kyu
Kokubo Satoshi
Yoshida Satoshi
Cho Hyun-Ji
Cha Bong-Soo
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Abstract
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Background: This is a subgroup analysis of Korean patients from a phase 3 clinical trial investigating the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin.
Methods: This multicenter, placebo-controlled, double-blind, parallel-group study was carried out between November 2011 and January 2013. Patients entered a 2-week placebo pretreatment period, followed by a 24-week treatment period with either ipragliflozin (50 mg/day) or placebo, while continuing metformin. Efficacy outcomes (glycosylated hemoglobin [HbA1c], fasting plasma glucose [FPG], and body weight) and safety outcomes (treatment-emergent adverse events [TEAEs]) were measured and compared between the two treatment groups for patients enrolled in all 18 study sites in Korea.
Results: Eighty-two Korean patients received ipragliflozin (n=43) or placebo (n=39) during the study period. Mean changes in HbA1c levels from baseline to the end of treatment were ?0.97% in the ipragliflozin group and ?0.31% in the placebo group, with an adjusted between-group difference of ?0.60% (P<0.001). Compared to placebo, FPG and body weight also decreased significantly (both P<0.001) from baseline after treatment in the ipragliflozin group, with between-group differences of ?21.4 mg/dL and ?1.53 kg, respectively. Decreased weight was the most common TEAE in the ipragliflozin group (7.0%); there were no reports of genital and urinary tract infection.
Conclusion: Ipragliflozin treatment in addition to metformin led to significant improvement in glycemic outcomes and reduction in body weight in Korean patients with type 2 diabetes mellitus, compared with metformin treatment alone; the safety profile was comparable in both groups.
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KEYWORD
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Asia, Diabetes mellitus, type 2, Ipragliflozin, Korea, Metformin, Randomized controlled trial, Sodium-glucose cotransporter 2 inhibitor
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