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Randomized Controlled Trial
. 2021 Nov;45(6):954-959.
doi: 10.4093/dmj.2020.0173. Epub 2020 Nov 12.

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  1 , Sang-Ah Chang  2 , Tae Seo Sohn  3 , Hyuk-Sang Kwon  4 , Jong Min Lee  5 , Sungdae Moon  6 , Pieter Proot  7 , Päivi M Paldánius  8   9 , Kun Ho Yoon  10
Affiliations
Randomized Controlled Trial

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 et al. Diabetes Metab J. 2021 Nov.

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.

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Conflict of interest statement

CONFLICTS OF INTEREST

Soon-Jib Yoo, Sang-Ah Chang, Tae Seo Sohn, Hyuk-Sang Kwon, Jong Min Lee, and Sungdae Moon have nothing to disclose. Pieter Proot is employed by and own stocks in Novartis. Päivi M. Paldánius was the medical lead of the VERIFY study and employed by Novartis Pharma AG at and up to the time of study completion. Kun Ho Yoon has served as a consultant for Novo Nordisk and MSD; received honorarium as a speaker from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceutical, MSD, Novo Nordisk, Sanofi, and Takeda; and received research support from AstraZeneca and Takeda.

Figures

Fig. 1.
Fig. 1.
Time to treatment failure. (A) Cumulative probability of initial treatment failure. (B) Cumulative probability of second treatment failure. The Kaplan-Meier (KM) estimates were performed for patients who had received at least one randomized medication and one post-randomization efficacy parameter assessed. Thus, not all patients included in the KM analysis had data at month 0. Hazard ratios are based on Cox regression analysis. CI, confidence interval; NE, not evaluable.
Fig. 2.
Fig. 2.
A) Glycosylated hemoglobin (HbA1c) levels over 12 months by treatment approaches and (B) long-term glycaemic durability in patients without treatment failure in both treatment groups (those remaining in Period 1). (A) Early combination: This group includes all patients who started treatment with vildagliptin plus metformin. Initial monotherapy: This group includes all patients who started treatment with metformin plus placebo. The analysis was performed for patients who had received at least one randomized medication and one post-randomization efficacy parameter assessed. (B) Patients failing on initial monotherapy: These patients received combination therapy after initial treatment failure with metformin monotherapy. Patients not failing on initial monotherapy: These patients continued with metformin monotherapy till the end of the study. Patients failing on early combination: These patients continued to receive combination therapy until secondary treatment failure. Patients not failing on early combination: These patients continued with the combination therapy till the end of the study.
None
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