Subject    :    [2017 Apr;41(2)] Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial
Writer KDA
Date 2017-07-06 11:02:30 Hit 5,618
Diabetes Metab J. 2017 Apr;41(2):135-145. English.
Published online Jan 11, 2017.  https://doi.org/10.4093/dmj.2017.41.2.135 
Copyright © 2017 Korean Diabetes Association
   
Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial
Kyung-Wan Min,1 Bon Jeong Ku,2 Ji-Hyun Lee,3 Min-Seon Kim,4 Kyu-Jeung Ahn,5 Moon-Kyu Lee,6 Satoshi Kokubo,7 Satoshi Yoshida,7 Hyun-Ji Cho,8 and Bong-Soo Cha9
1Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.
2Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea.
3Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
4Division of Endocrinology and Metabolism, Department of Internal Medicine, University of Ulsan College of Medicine, Seoul, Korea.
5Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University Medical Center, Seoul, Korea.
6Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
7Astellas Pharma Inc., Tokyo, Japan.
8Astellas Korea Inc., Seoul, Korea.
9Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.

Corresponding author: Bong-Soo Cha. Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. Email: bscha@yuhs.ac 
 
Received August 01, 2016; Accepted October 25, 2016.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

 
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.

   
Keywords:
Asia; Diabetes mellitus, type 2; Ipragliflozin; Korea; Metformin; Randomized controlled trial; Sodium-glucose cotransporter 2 inhibitor

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