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Brief Report
- Drug/Regimen
- Long-Term Glycaemic Durability of Early Combination Therapy Strategy versus Metformin Monotherapy in Korean Patients with Newly Diagnosed Type 2 Diabetes Mellitus
- Soon-Jib Yoo, Sang-Ah Chang, Tae Seo Sohn, Hyuk-Sang Kwon, Jong Min Lee, Sungdae Moon, Pieter Proot, Päivi M Paldánius, Kun Ho Yoon
- Diabetes Metab J. 2021;45(6):954-959. Published online November 12, 2020
- DOI: https://doi.org/10.4093/dmj.2020.0173
- 56,609 View
- 407 Download
- 4 Web of Science
- 3 Crossref
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Graphical Abstract
Abstract
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Supplementary Material
PubReader 
ePub - We assessed the glycaemic durability with early combination (EC; vildagliptin+metformin [MET], n=22) versus MET monotherapy (n=17), among newly-diagnosed type 2 diabetes mellitus (T2DM) enrolled (between 2012 and 2014) in the VERIFY study from Korea (n=39). Primary endpoint was time to initial treatment failure (TF) (glycosylated hemoglobin [HbA1c] ≥7.0% at two consecutive scheduled visits after randomization [end of period 1]). Time to second TF was assessed when both groups were receiving and failing on the combination (end of period 2). With EC the risk of initial TF significantly reduced by 78% compared to MET (n=3 [15%] vs. n=10 [58.7%], P=0.0228). No secondary TF occurred in EC group versus five patients (29.4%) in MET. Patients receiving EC treatment achieved consistently lower HbA1c levels. Both treatment approaches were well tolerated with no hypoglycaemic events. In Korean patients with newly diagnosed T2DM, EC treatment significantly and consistently improved the long-term glycaemic durability as compared with MET.
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Citations
Citations to this article as recorded by
- Efficacy and Safety of Alogliptin-Pioglitazone Combination for Type 2 Diabetes Mellitus Poorly Controlled with Metformin: A Multicenter, Double-Blind Randomized Trial
Ji-Yeon Park, Joonyub Lee, Yoon-Hee Choi, Kyung Wan Min, Kyung Ah Han, Kyu Jeung Ahn, Soo Lim, Young-Hyun Kim, Chul Woo Ahn, Kyung Mook Choi, Kun-Ho Yoon
Diabetes & Metabolism Journal.2024; 48(5): 915. CrossRef - 2023 Clinical Practice Guidelines for Diabetes Mellitus of the Korean Diabetes Association
Jong Han Choi, Kyung Ae Lee, Joon Ho Moon, Suk Chon, Dae Jung Kim, Hyun Jin Kim, Nan Hee Kim, Ji A Seo, Mee Kyoung Kim, Jeong Hyun Lim, YoonJu Song, Ye Seul Yang, Jae Hyeon Kim, You-Bin Lee, Junghyun Noh, Kyu Yeon Hur, Jong Suk Park, Sang Youl Rhee, Hae J
Diabetes & Metabolism Journal.2023; 47(5): 575. CrossRef - 2021 Clinical Practice Guidelines for Diabetes Mellitus of the Korean Diabetes Association
Kyu Yeon Hur, Min Kyong Moon, Jong Suk Park, Soo-Kyung Kim, Seung-Hwan Lee, Jae-Seung Yun, Jong Ha Baek, Junghyun Noh, Byung-Wan Lee, Tae Jung Oh, Suk Chon, Ye Seul Yang, Jang Won Son, Jong Han Choi, Kee Ho Song, Nam Hoon Kim, Sang Yong Kim, Jin Wha Kim,
Diabetes & Metabolism Journal.2021; 45(4): 461. CrossRef
- Efficacy and Safety of Alogliptin-Pioglitazone Combination for Type 2 Diabetes Mellitus Poorly Controlled with Metformin: A Multicenter, Double-Blind Randomized Trial
Original Articles
- Predictive Clinical Parameters and Glycemic Efficacy of Vildagliptin Treatment in Korean Subjects with Type 2 Diabetes
- Jin-Sun Chang, Juyoung Shin, Hun-Sung Kim, Kyung-Hee Kim, Jeong-Ah Shin, Kun-Ho Yoon, Bong-Yun Cha, Ho-Young Son, Jae-Hyoung Cho
- Diabetes Metab J. 2013;37(1):72-80. Published online February 15, 2013
- DOI: https://doi.org/10.4093/dmj.2013.37.1.72
- 4,586 View
- 39 Download
- 2 Crossref
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Abstract
PDFPubReader
Background The aims of this study are to investigate the glycemic efficacy and predictive parameters of vildagliptin therapy in Korean subjects with type 2 diabetes.
Methods In this retrospective study, we retrieved data for subjects who were on twice-daily 50 mg vildagliptin for at least 6 months, and classified the subjects into five treatment groups. In three of the groups, we added vildagliptin to their existing medication regimen; in the other two groups, we replaced one of their existing medications with vildagliptin. We then analyzed the changes in glucose parameters and clinical characteristics.
Results Ultimately, 327 subjects were analyzed in this study. Vildagliptin significantly improved hemoglobin A1c (HbA1c) levels over 6 months. The changes in HbA1c levels (ΔHbA1c) at month 6 were -2.24% (
P =0.000), -0.77% (P =0.000), -0.80% (P =0.001), -0.61% (P =0.000), and -0.34% (P =0.025) for groups 1, 2, 3, 4, and 5, respectively, with significance. We also found significant decrements in fasting plasma glucose levels in groups 1, 2, 3, and 4 (P <0.05). Of the variables, initial HbA1c levels (P =0.032) and history of sulfonylurea use (P =0.026) were independently associated with responsiveness to vildagliptin treatment.Conclusion Vildagliptin was effective when it was used in subjects with poor glycemic control. It controlled fasting plasma glucose levels as well as sulfonylurea treatment in Korean type 2 diabetic subjects.
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Citations
Citations to this article as recorded by- Predictive clinical parameters for the hemoglobin A1c-lowering effect of vildagliptin in Japanese patients with type 2 diabetes
Yukihiro Bando, Masayuki Yamada, Keiko Aoki, Hideo Kanehara, Azusa Hisada, Kazuhiro Okafuji, Daisyu Toya, Nobuyoshi Tanaka
Diabetology International.2014; 5(4): 229. CrossRef - The Efficacy of Vildagliptin in Korean Patients with Type 2 Diabetes
Jun Sung Moon, Kyu Chang Won
Diabetes & Metabolism Journal.2013; 37(1): 36. CrossRef
- Predictive clinical parameters for the hemoglobin A1c-lowering effect of vildagliptin in Japanese patients with type 2 diabetes
- Comparison of Vildagliptin-Metformin and Glimepiride-Metformin Treatments in Type 2 Diabetic Patients
- Hyun Jeong Jeon, Tae Keun Oh
- Diabetes Metab J. 2011;35(5):529-535. Published online October 31, 2011
- DOI: https://doi.org/10.4093/dmj.2011.35.5.529
- 65,535 View
- 135 Download
- 26 Crossref
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Abstract
PDFPubReader
Background The present study investigated the efficacy and safety of vildagliptin-metformin treatment compared to those of glimepiride-metformin treatment for type 2 diabetes.
Methods In a randomized, open-label, comparative study, 106 patients with type 2 diabetes were enrolled. The primary endpoint was a reduction in HbA1c from baseline and secondary endpoints included fasting plasma glucose (FPG) or 2-hour postprandial glucose (2h-PPG) reduction from baseline, as well as HbA1c responder rate and HbA1c reduction according to baseline HbA1c category.
Results Comparable HbA1c reduction was observed with a mean±standard deviation change from baseline to the 32-week endpoint of -0.94±1.15% in the vildagliptin group and -1.00±1.32% in the glimepiride group. A similar reduction in 2h-PPG (vildagliptin group 3.53±4.11 mmol/L vs. the glimepiride group 3.72±4.17 mmol/L) was demonstrated, and the decrements in FPG (vildagliptin group 1.54±2.41 mmol/L vs. glimepiride group 2.16±2.51 mmol/L) were not different between groups. The proportion of patients who achieved an HbA1c less than 7% at week 32 was 50.1% in the vildagliptin group and 56.0% in the glimepiride group. An average body weight gain of 2.53±1.21 kg in the glimepiride group was observed in contrast with the 0.23±0.69 kg weight gain noted in the vildagliptin group. A 10-fold lower incidence of hypoglycemia was demonstrated in the vildagliptin group, in addition to an absence of severe hypoglycemia.
Conclusion Vildagliptin-metformin treatment provided blood glucose control efficacy comparable to that of glimepiride-metformin treatment and resulted in better adverse event profiles with lower risks of hypoglycemia and weight gain.
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Citations
Citations to this article as recorded by- A COMPARATIVE STUDY TO ASSESS THE SAFETY AND EFFICACY OF SOME ORAL TRIPLE THERAPY REGIMENS IN PATIENTS WITH UNCONTROLLED TYPE 2 DIABETES MELLITUS
LAVANYA G., MAKARANDH A., VENKATESHWARLU E., SHARAVANABHAVA B. S., SATHYANARAYANA K.
International Journal of Pharmacy and Pharmaceutical Sciences.2025; : 28. CrossRef - A Randomized, Two-Treatments, Two-Periods, Crossover, Open label, Laboratory-Blind, Single Dose Bioequivalence Study between Vildagliptin/Metformin 50 mg/1000 mg Film Coated Tablets (Sensityn®) and Galvusmet® 50 mg/1000 mg Film Coated Tablets in healthy a
J. Shiekmydeen, T. Siddiqi, K. Chakraborty, S. Khalaf, M. Albarazi, I. Eqtefan, J. Sliva
European Pharmaceutical Journal.2023; 70(2): 1. CrossRef - Bioequivalence Studies of New Generic Formulations of Vildagliptin and Fixed-Drug Combination of Vildagliptin and Metformin Versus Respective Originator Products in Healthy Volunteers
Yvonne Schnaars, Sumedh Gaikwad, Ulrike Gottwald-Hostalek, Ulrike Klingberg, Hari Kiran Chary Vadla, Vamshi Ramana Prathap
Diabetes Therapy.2022; 13(6): 1215. CrossRef - Efficacy and safety of dorzagliatin for type 2 diabetes mellitus: A meta-analysis and trial sequential analysis
Yunfeng Yu, Xingyu Yang, Keke Tong, Shuang Yin, Gang Hu, Fei Zhang, Pengfei Jiang, Manli Zhou, Weixiong Jian
Frontiers in Cardiovascular Medicine.2022;[Epub] CrossRef - A Single-Center, Observational, Retrospective Cost-Effective Analysis of Treating Inadequately Controlled Type 2 Diabetes Mellitus by Addition of DPP4 Inhibitors Versus Intensified Treatment with Conventional Drugs
Akshata Kalyani, Sachin Kuchya, >Prashant Punekar
Journal of Pharmacology and Pharmacotherapeutics.2021; 12(3): 125. CrossRef - Comparison of safety and efficacy of glimepiride-metformin and vildagliptin- metformin treatment in newly diagnosed type 2 diabetic patients
Surendra Kumar
Indian Journal of Endocrinology and Metabolism.2021; 25(4): 326. CrossRef - Comparative clinical study evaluating the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin therapy on diabetic patients with symptomatic coronary artery disease
Rehab Werida, Mahmoud Kabel, Gamal Omran, Ahmed Shokry, Tarek Mostafa
Diabetes Research and Clinical Practice.2020; 170: 108473. CrossRef - Efficacy of different antidiabetic drugs based on metformin in the treatment of type 2 diabetes mellitus: A network meta‐analysis involving eight eligible randomized‐controlled trials
Yan Peng, Shu‐Hong Chen, Xiao‐Nan Liu, Qing‐Yun Sun
Journal of Cellular Physiology.2019; 234(3): 2795. CrossRef - A safety and tolerability profile comparison between dipeptidyl peptidase-4 inhibitors and sulfonylureas in diabetic patients: A systematic review and meta-analysis
Daniela Farah, Graziella Malzoni Leme, Freddy Goldberg Eliaschewitz, Marcelo Cunio Machado Fonseca
Diabetes Research and Clinical Practice.2019; 149: 47. CrossRef - Efficacy and safety of dulaglutide monotherapy compared with glimepiride in East‐Asian patients with type 2 diabetes in a multicentre, double‐blind, randomized, parallel‐arm, active comparator, phase III trial
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Diabetes, Obesity and Metabolism.2018; 20(9): 2121. CrossRef - Cost effectiveness of vildagliptin versus glimepiride as add-on treatment to metformin for the treatment of diabetes mellitus type 2 patients in Greece
Hara Kousoulakou, Magdalini Hatzikou, Varvara Baroutsou, John Yfantopoulos
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Expert Opinion on Pharmacotherapy.2017; 18(12): 1179. CrossRef - Predictors of efficacy of GLP-1 agonists and DPP-4 inhibitors: A systematic review
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Journal of Diabetes Mellitus.2015; 05(04): 211. CrossRef - Glycemic effects of vildagliptin and metformin combination therapy in Indian patients with type 2 diabetes: An observational study (印度2型糖尿病患者使用维格列汀与二甲双胍联合治疗对血糖的影响：一项观察性研究)
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Diabetes & Metabolism Journal.2013; 37(1): 36. CrossRef - Effect of Vildagliptin on Glucose and Insulin Concentrations During a 24-Hour Period in Type 2 Diabetes Patients with Different Ranges of Baseline Hemoglobin A1c Levels
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