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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
  • 55,246 View
  • 370 Download
  • 3 Web of Science
  • 2 Crossref
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary MaterialPubReader   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 to this article as recorded by  
  • 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
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
  • 3,820 View
  • 32 Download
  • 2 Crossref
AbstractAbstract 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.

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
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
  • 106 Download
  • 25 Crossref
AbstractAbstract 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.

Citations

Citations to this article as recorded by  
  • 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
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    European Pharmaceutical Journal.2023; 70(2): 1.     CrossRef
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    Yvonne Schnaars, Sumedh Gaikwad, Ulrike Gottwald-Hostalek, Ulrike Klingberg, Hari Kiran Chary Vadla, Vamshi Ramana Prathap
    Diabetes Therapy.2022; 13(6): 1215.     CrossRef
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    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
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    Journal of Pharmacology and Pharmacotherapeutics.2021; 12(3): 125.     CrossRef
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    Surendra Kumar
    Indian Journal of Endocrinology and Metabolism.2021; 25(4): 326.     CrossRef
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    Rehab Werida, Mahmoud Kabel, Gamal Omran, Ahmed Shokry, Tarek Mostafa
    Diabetes Research and Clinical Practice.2020; 170: 108473.     CrossRef
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    Yan Peng, Shu‐Hong Chen, Xiao‐Nan Liu, Qing‐Yun Sun
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    Hara Kousoulakou, Magdalini Hatzikou, Varvara Baroutsou, John Yfantopoulos
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    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
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    Jun Sung Moon, Kyu Chang Won
    Diabetes & Metabolism Journal.2013; 37(1): 36.     CrossRef
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