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CLINICAL TRIAL article

Front. Endocrinol.

Sec. Clinical Diabetes

Volume 16 - 2025 | doi: 10.3389/fendo.2025.1508918

The effects of vildagliptin on glycemic variability in patients with type 2 diabetes on premixed insulin therapy

Provisionally accepted
Deyue  KongDeyue Kong1Ziyang  ShenZiyang Shen1Lanlan  JiangLanlan Jiang1Xiaojing  XieXiaojing Xie1Rengna  YanRengna Yan1Ting  JingTing Jing1Yun  HuYun Hu2*Jianhua  MaJianhua Ma1*
  • 1Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University,, Nanjing, China
  • 2Wuxi No.2 People's Hospital, Nanjing Medical University, Wuxi, Jiangsu Province, China

The final, formatted version of the article will be published soon.

Aim: Patients on premixed insulin therapy usually have poor glycemic control. This study aimed to investigate the effect of vildagliptin in these patients. Methods: This real-world study included patients with type 2 diabetes mellitus (T2DM), who were poorly glycemic controlled on premixed insulin therapy and were subsequently added vildagliptin. The control group consisted of patients who only had their insulin doses adjusted without adding vildagliptin, matched for age, diabetic duration, HbA1c, and BMI. All patients underwent FGM, glycated hemoglobin(HbA1c), and glycated albumin(GA) measurements at baseline and three months after the treatment adjustment. Results: Patients receiving vildagliptin treatment demonstrated significant reductions in HbA1c and GA levels (P<0.001 and P=0.009, respectively). The vildagliptin group exhibited a remarkable decrease in the mean amplitude of glycemic excursion (MAGE) (8.58±0.36 vs. 6.62±0.47, P<0.001), along with notable reductions in mean blood glucose (MBG) (10.7±0.34 vs. 8.82±0.39, P<0.001) and time above the target range (TAR) (52.60±3.44 vs. 31.59±4.31, P<0.001) compared to the control group. Moreover, there were notable improvements in the duration spent within the target range (TIR) (45.64±3.33 vs. 64.22±4.00, P<0.001), along with increases in the areas under the curve (AUC) for blood glucose levels above 4. 4 (426.82±83.19 vs. 892.16± 185.27, P=0.018) and 3.9 (213.81±47.20 vs. 454.77±103.21, P=0.029). Hourly mean blood glucose levels over a 2-week period monitored by FGM indicated lower blood glucose levels in the vildagliptin group, particularly after dinner (P=0.022).Vildagliptin added to premixed insulin effectively lowers blood glucose levels and reduces glycemic variability in patients with type 2 diabetes mellitus. Clinical Trial Registration: https://clinicaltrials.gov/NCT04847219.

Keywords: vildagliptin, type 2 diabetes mellitus, Glycemic excursion, flash glucose monitoring, Premixed insulin

Received: 10 Oct 2024; Accepted: 04 Jun 2025.

Copyright: © 2025 Kong, Shen, Jiang, Xie, Yan, Jing, Hu and Ma. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Yun Hu, Wuxi No.2 People's Hospital, Nanjing Medical University, Wuxi, Jiangsu Province, China
Jianhua Ma, Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University,, Nanjing, China

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