Original Article Others Diabetes Metab J 2016;40:230-239 http://dx.doi.org/10.4093/dmj.2016.40.3.230 pISSN 2233-6079 · eISSN 2233-6087

DIABETES & METABOLISM JOURNAL

Comparison of Vildagliptin and Pioglitazone in Korean Patients with Type 2 Diabetes Inadequately Controlled with Metformin Jong Ho Kim1,*, Sang Soo Kim1,*, Hong Sun Baek2, In Kyu Lee3, Dong Jin Chung4, Ho Sang Sohn5, Hak Yeon Bae6, Mi Kyung Kim7, Jeong Hyun Park8, Young Sik Choi9, Young Il Kim10, Jong Ryeal Hahm11, Chang Won Lee12, Sung Rae Jo13, Mi Kyung Park14, Kwang Jae Lee15, In Joo Kim1 Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, 3 Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, 4 Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, 5 Department of Internal Medicine, Daegu Catholic University Medical Center, Catholic University of Daegu School of Medicine, Daegu, 6 Department of Internal Medicine, Chosun University Hospital, Chosun University School of Medicine, Gwangju, 7 Department of Internal Medicine, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, 8 Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, 9 Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, 10 Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, 11 Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, 12 Department of Internal Medicine, Busan St. Mary’s Hospital, Catholic University of Pusan, Busan, 13 Department of Internal Medicine, Changwon Fatima Hospital, Changwon, 14 Department of Internal Medicine, Dong-A Medical Center, Dong-A University College of Medicine, Busan, 15 Department of Internal Medicine, Daedong Hospital, Busan, Korea 1 2

Background: We compared the efficacies of vildagliptin (50 mg twice daily) relative to pioglitazone (15 mg once daily) as an addon treatment to metformin for reducing glycosylated hemoglobin (HbA1c) levels in Korean patients with type 2 diabetes. Methods: The present study was a multicenter, randomized, active-controlled investigation comparing the effects of vildagliptin and pioglitazone in Korean patients receiving a stable dose of metformin but exhibiting inadequate glycemic control. Each patient underwent a 16-week treatment period with either vildagliptin or pioglitazone as an add-on treatment to metformin. Results: The mean changes in HbA1c levels from baseline were –0.94% in the vildagliptin group and –0.6% in the pioglitazone group and the difference between the treatments was below the non-inferiority margin of 0.3%. The mean changes in postprandial plasma glucose (PPG) levels were –60.2 mg/dL in the vildagliptin group and –38.2 mg/dL in the pioglitazone group and these values significantly differed (P=0.040). There were significant decreases in the levels of total, low density lipoprotein, high density lipoprotein (HDL), and non-HDL cholesterol in the vildagliptin group but increases in the pioglitazone group. The mean change in body weight was –0.07 kg in the vildagliptin group and 0.69 kg in the pioglitazone group, which were also significantly different (P=0.002). Conclusion: As an add-on to metformin, the efficacy of vildagliptin for the improvement of glycemic control is not inferior to that of pioglitazone in Korean patients with type 2 diabetes. In addition, add-on treatment with vildagliptin had beneficial effects on PPG levels, lipid profiles, and body weight compared to pioglitazone. Keywords: Dipeptidyl peptidase 4 inhibitor; Metformin; Thiazolidinediones

Corresponding author:  In Joo Kim http://orcid.org/0000-0003-1307-6146 Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, 179 Gudeok-ro, Seo-gu, Busan 49241, Korea E-mail: [email protected] *Jong Ho Kim and Sang Soo Kim contributed equally to this study as first authors. Received: Jul. 24, 2015; Accepted: Sep. 18, 2015

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Copyright © 2016 Korean Diabetes Association

http://e-dmj.org

Metformin, vildagliptin, pioglitazone

INTRODUCTION The prevalence of diabetes continues to rapidly increase worldwide, including in Korea. In 2013, 382 million people around the world had diabetes and that number is expected to rise to 592 million by 2035 [1]. In Korea, the prevalence of diabetes has increased from 1.5% to 9.9% over the past 40 years [2] and diabetes and its complications have become a major cause of morbidity and mortality [3]. Therefore, public efforts to achieve effective glycemic control are necessary to reduce the impact of the global epidemic of diabetes.   In conjunction with lifestyle interventions, the use of metformin as a first-line treatment for type 2 diabetes is well established [4]. However, when additional treatment is required to achieve or maintain glycosylated hemoglobin (HbA1c) levels at 1.3 times ULN, serum creatinine levels >1.5 mg/dL, and/or clinically abnormal thyroid-stimulating hormone levels. Study assessments The body weights and vital signs of each patient were measured at each visit. Fasting lipid profiles (triglyceride [TG], total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], and non-HDL-C levels), standard hematology and biochemistry laboratory assessments, and homeostasis model assessment as an index of insulin resistance (HOMA-IR) and the homeostatic model assessment β-cell function (HOMA-β) were obtained at the initial screening and at weeks 4, 12, and 16. HOMA-IR and HOMA-β represent insulin resistance and pancreatic β-cell function, respectively, and were calculated as follows: HOMA-IR=fasting insulin (FI, μU/mL)×FPG (mmol/L)/22.5, and HOMA-β =20×FI (μU/mL)/[FPG (mmol/L)–3.5]. In addition, electrocardiograms were performed at the screening and week 16.   At each post-baseline visit, all adverse events (AEs) were re-

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corded and assessed for severity and a possible relationship to the study medications. Patients were provided with glucose monitoring devices to determine hypoglycemia, which was defined as symptoms suggestive of low glucose confirmed by a self-monitored glucose measurement of

Comparison of Vildagliptin and Pioglitazone in Korean Patients with Type 2 Diabetes Inadequately Controlled with Metformin.

We compared the efficacies of vildagliptin (50 mg twice daily) relative to pioglitazone (15 mg once daily) as an add-on treatment to metformin for red...
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