Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial.
10.4093/dmj.2017.41.2.135
- Author:
Kyung Wan MIN
1
;
Bon Jeong KU
;
Ji Hyun LEE
;
Min Seon KIM
;
Kyu Jeung AHN
;
Moon Kyu LEE
;
Satoshi KOKUBO
;
Satoshi YOSHIDA
;
Hyun Ji CHO
;
Bong Soo CHA
Author Information
1. Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.
- Publication Type:Clinical Trial ; Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Asia;
Diabetes mellitus, type 2;
Ipragliflozin;
Korea;
Metformin;
Randomized controlled trial;
Sodium-glucose cotransporter 2 inhibitor
- MeSH:
Asia;
Blood Glucose;
Body Weight;
Diabetes Mellitus, Type 2*;
Fasting;
Humans;
Korea;
Metformin*;
Urinary Tract Infections
- From:Diabetes & Metabolism Journal
2017;41(2):135-145
- CountryRepublic of Korea
- Language:English
-
Abstract:
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.
