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

doi:10.4093/dmj.2020.0173

Long-Term Glycaemic Durability of Early Combination Therapy Strategy versus Metformin Monotherapy in Korean Patients with Newly Diagnosed Type 2 Diabetes Mellitus

Diabetes Metab J. 2021 Nov;45(6):954-959. doi: 10.4093/dmj.2020.0173. Epub 2020 Nov 12.

Authors

Soon-Jib Yoo¹, Sang-Ah Chang², Tae Seo Sohn³, Hyuk-Sang Kwon⁴, Jong Min Lee⁵, Sungdae Moon⁶, Pieter Proot⁷, Päivi M Paldánius^{8

9}, Kun Ho Yoon¹⁰

Affiliations

¹ Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea.
² Division of Endocrinology and Metabolism, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
³ Division of Endocrinology and Metabolism, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea.
⁴ Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
⁵ Division of Endocrinology and Metabolism, Department of Internal Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Daejeon, Korea.
⁶ Division of Endocrinology and Metabolism, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.
⁷ Novartis Pharma AG, Basel, Switzerland.
⁸ Children's Hospital, Helsinki University Central Hospital, Helsinki, Finland.
⁹ Research Program for Clinical and Molecular Metabolism, Helsinki University, Helsinki, Finland.
¹⁰ Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

Abstract

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.

Keywords: Diabetes mellitus, type 2; Drug therapy, combination; Glycated hemoglobin A; Korea; Metformin; Vildagliptin.

Publication types

Randomized Controlled Trial

MeSH terms

Diabetes Mellitus, Type 2* / diagnosis
Diabetes Mellitus, Type 2* / drug therapy
Drug Therapy, Combination / adverse effects
Glycated Hemoglobin / analysis
Humans
Hypoglycemic Agents / adverse effects
Korea
Metformin* / adverse effects
Treatment Outcome

Substances

Glycated Hemoglobin A
Hypoglycemic Agents
Metformin