- Drug Regimen
- Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
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Jun Sung Moon, Il Rae Park, Hae Jin Kim, Choon Hee Chung, Kyu Chang Won, Kyung Ah Han, Cheol-Young Park, Jong Chul Won, Dong Jun Kim, Gwan Pyo Koh, Eun Sook Kim, Jae Myung Yu, Eun-Gyoung Hong, Chang Beom Lee, Kun-Ho Yoon
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Diabetes Metab J. 2023;47(6):808-817. Published online September 26, 2023
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DOI: https://doi.org/10.4093/dmj.2022.0387
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Abstract
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- Background
This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.
Methods In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).
Results Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.
Conclusion Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.
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Citations
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- Clinical-economic assessment of the potential contribution of evogliptin to achieving the targets of the Federal project «Fight against diabetes mellitus» and reduction of population mortality
N. N. Avxentyev, A. S. Makarov, I. A. Karpova, V. V. Yavlyanskaya Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice.2025; (4): 55. CrossRef - Design, synthesis, and biological evaluation of quinazolinone-dihydropyrimidinone as a potential anti-diabetic agent via GLUT4 translocation stimulation
Arvind Kumar Jaiswal, Ajay Kishor Kushawaha, Pawan kumar, Alisha Ansari, Nikita Chhikara, Hemlata bhatt, Sarita Katiyar, Ishbal Ahmad, Abhijit Deb Choudhury, Rabi Sankar Bhatta, Akhilesh K. Tamrakar, Koneni V. Sashidhara European Journal of Medicinal Chemistry.2025; 288: 117366. CrossRef - Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study
In‐Kyung Jeong, Kyung Mook Choi, Kyung Ah Han, Kyoung‐Ah Kim, In Joo Kim, Seung Jin Han, Won Young Lee, Soon Jib Yoo Diabetes, Obesity and Metabolism.2024; 26(11): 5065. CrossRef
- Risk Factors Associated with Left Ventricular Diastolic Dysfunction in Type 2 Diabetic Patients without Hypertension
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Jung Hyun Noh, Joon Hyung Doh, Sung Yun Lee, Tae Nyun Kim, Hyuk Lee, Hwa Young Song, Jeong Hyun Park, Kyung Soo Ko, Byoung Doo Rhee, Dong Jun Kim
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Korean Diabetes J. 2010;34(1):40-46. Published online February 28, 2010
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DOI: https://doi.org/10.4093/kdj.2010.34.1.40
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- Background
Hypertension and age are recognized as important risk factors for left ventricular (LV) diastolic dysfunction. Some studies have shown that diabetes itself may also be an independent risk factor for LV diastolic dysfunction, although this is controversial. The aim of this study was to determine the factors associated with LV diastolic dysfunction in patients with type 2 diabetes in the absence of hypertension or ischemic heart disease (IHD). MethodsParticipants in this study consisted of 65 type 2 diabetes patients (M : F = 45 : 20; mean age 51 [26 to 76] years; mean body mass index [BMI] 25.0 ± 2.5 kg/m2) without hypertension, heart disease, or renal disease. Individuals with ischemic electrocardiographic changes were excluded. LV diastolic function was evaluated by Doppler echocardiographic studies. ResultsFifteen patients (23.1%) showed LV diastolic dysfunction on Doppler echocardiographic studies. Patients with LV diastolic dysfunction were older than those without diastolic dysfunction (60.0 ± 2.5 vs. 50.5 ± 1.9 years; P < 0.01). After adjusting for age and sex, BMI was higher (26.6 ± 0.7 vs. 24.6 ± 0.3 kg/m2; P < 0.01) and diabetes duration was longer (9.65 ± 1.48 vs. 4.71 ± 0.78 years; P < 0.01) in patients with LV diastolic dysfunction than in those without diastolic dysfunction. There were no differences in sex, smoking, blood pressure, lipid profiles, hemoglobin A1C, fasting glucose, fasting insulin, or diabetic microvascular complications between the LV diastolic dysfunction group and the normal diastolic function group. After adjusting for age, sex, and BMI, diabetes duration was found to be independently associated with LV diastolic dysfunction (odds ratio 1.38; confidence interval 1.12 to 1.72; P = 0.003). ConclusionThese results suggest that diabetes duration may be a risk factor for LV diastolic dysfunction in type 2 diabetic patients without hypertension or IHD.
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Citations
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- Reducing Cardiac Steatosis: Interventions to Improve Diastolic Function: A Narrative Review
Kiyan Heshmat-Ghahdarijani, Roya Modaresi, Sobhan Pourmasjedi, Setayesh Sotoudehnia Korani, Ali Rezazadeh Roudkoli, Razieh Ziaei, Armita Farid, Mehrnaz Salehi, Afshin Heidari, Sina Neshat Current Problems in Cardiology.2023; 48(8): 101739. CrossRef - Glycemic variability is associated with diastolic dysfunction in patients with type 2 diabetes
Yana Dzhun, Georgy Mankovsky, Nadiya Rudenko, Yevgen Marushko, Yanina Saienko, Borys Mankovsky Journal of Diabetes and its Complications.2023; 37(11): 108519. CrossRef - Lipids and diastolic dysfunction: Recent evidence and findings
Padideh Daneii, Sina Neshat, Monir Sadat Mirnasiry, Zahra Moghimi, Fatemeh Dehghan Niri, Armita Farid, Setayesh Sotoudehnia Korani, Masood Shekarchizadeh, Kiyan Heshmat-Ghahdarijani Nutrition, Metabolism and Cardiovascular Diseases.2022; 32(6): 1343. CrossRef - Does diabetes increase the risk of cardiovascular events in patients with negative treadmill stress echocardiography?
So Young Yang, Hui-Jeong Hwang Endocrine Journal.2022; 69(7): 785. CrossRef - Factors associated with left ventricular diastolic dysfunction in patients with septic shock
Wei-Dong Ge, Feng-Zhi Li, Bang-Chuan Hu, Li-Hong Wang, Ding-Yuan Ren European Journal of Medical Research.2022;[Epub] CrossRef - An in-depth analysis of glycosylated haemoglobin level, body mass index and left ventricular diastolic dysfunction in patients with type 2 diabetes
Xin Zuo, Xueting Liu, Runtian Chen, Huiting Ou, Jiabao Lai, Youming Zhang, Dewen Yan BMC Endocrine Disorders.2019;[Epub] CrossRef - Early detection of left ventricular diastolic dysfunction using conventional and speckle tracking echocardiography in a large animal model of metabolic dysfunction
Mark M. P. van den Dorpel, Ilkka Heinonen, Sanne M. Snelder, Hendrik J. Vos, Oana Sorop, Ron T. van Domburg, Daphne Merkus, Dirk J. Duncker, Bas M. van Dalen The International Journal of Cardiovascular Imaging.2017;[Epub] CrossRef - Risk Factors Associated with Left Ventricular Diastolic Dysfunction in Type 2 Diabetic Patients without Hypertension (Korean Diabetes J 2010;34:40-6)
Dong-Lim Kim Korean Diabetes Journal.2010; 34(2): 135. CrossRef
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