Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial
BackgroundThis 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.MethodsThis multicenter, placebo-controlled, double-blind, parallel-group stu...
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Korean Diabetes Association
2017-01-01
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doaj-f4d0fd79a711449faae8ed5ed3e5a9f42020-11-24T23:40:47ZengKorean Diabetes AssociationDiabetes & Metabolism Journal2233-60792233-60872017-01-0141213514510.4093/dmj.2017.41.2.135Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 TrialKyung-Wan Min0Bon Jeong Ku1Ji-Hyun Lee2Min-Seon Kim3Kyu-Jeung Ahn4Moon-Kyu Lee5Satoshi Kokubo6Satoshi Yoshida7Hyun-Ji Cho8Bong-Soo Cha9Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea.Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.Division of Endocrinology and Metabolism, Department of Internal Medicine, University of Ulsan College of Medicine, Seoul, Korea.Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University Medical Center, Seoul, Korea.Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.Astellas Pharma Inc., Tokyo, Japan.Astellas Pharma Inc., Tokyo, Japan.Astellas Korea Inc., Seoul, Korea.Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.BackgroundThis 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.MethodsThis 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.ResultsEighty-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.ConclusionIpragliflozin 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.https://e-dmj.org/Synapse/Data/PDFData/2004DMJ/dmj-41-135.pdfAsiaDiabetes mellitus, type 2IpragliflozinKoreaMetforminRandomized controlled trialSodium-glucose cotransporter 2 inhibitor |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Kyung-Wan Min 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 |
spellingShingle |
Kyung-Wan Min 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 Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial Diabetes & Metabolism Journal Asia Diabetes mellitus, type 2 Ipragliflozin Korea Metformin Randomized controlled trial Sodium-glucose cotransporter 2 inhibitor |
author_facet |
Kyung-Wan Min 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_sort |
Kyung-Wan Min |
title |
Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial |
title_short |
Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial |
title_full |
Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial |
title_fullStr |
Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial |
title_full_unstemmed |
Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial |
title_sort |
addition of ipragliflozin to metformin treatment in korean patients with type 2 diabetes mellitus: subgroup analysis of a phase 3 trial |
publisher |
Korean Diabetes Association |
series |
Diabetes & Metabolism Journal |
issn |
2233-6079 2233-6087 |
publishDate |
2017-01-01 |
description |
BackgroundThis 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.MethodsThis 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.ResultsEighty-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.ConclusionIpragliflozin 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. |
topic |
Asia Diabetes mellitus, type 2 Ipragliflozin Korea Metformin Randomized controlled trial Sodium-glucose cotransporter 2 inhibitor |
url |
https://e-dmj.org/Synapse/Data/PDFData/2004DMJ/dmj-41-135.pdf |
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