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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
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
Diabetes Metab J. 2023;47(6):808-817.   Published online September 26, 2023
DOI: https://doi.org/10.4093/dmj.2022.0387
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  • 345 Download
  • 1 Web of Science
  • 1 Crossref
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
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.

Citations

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  • 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
The Biochemical Markers of Coronary Heart Disease Correlates Better to Metabolic Syndrome Defined by WHO than by NCEP-ATP III or IDF in Korean Type 2 Diabetic Patients.
Dong Mee Lim, Keun Young Park, Gwan Pyo Koh
Korean Diabetes J. 2008;32(2):157-164.   Published online April 1, 2008
DOI: https://doi.org/10.4093/kdj.2008.32.2.157
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  • 29 Download
  • 5 Crossref
AbstractAbstract PDF
BACKGROUND
Metabolic syndrome (MetS) is constellation of cardiovascular risk factors. There are three typically used definitions of MetS proposed by WHO, IDF and NCEP-ATP III. We conducted this study to compare the associations of MetS by WHO, IDF and NCEP-ATP III definition to various metabolic markers of coronary heart diseases in Korean type 2 diabetes patients. METHODS: We enrolled 151 Korean type 2 diabetes patients in one hospital. Anthropometric and biochemical parameters, including high-sensitivity C-reactive protein (hsCRP), homocysteine, uric acid were measured. And then, we divided MetS group from non-MetS group according to three other definitions. RESULTS: Serum hsCRP level was higher in those with MetS group than non-MetS group by WHO definition (0.33 +/- 0.36 mg/dL vs 0.18 +/- 0.26 mg/dL, P < 0.001). But, there are no difference in MetS group and non-MetS group by IDF and NCEP-ATPIII definition. (By IDF, 0.28 +/- 0.31 mg/dL vs 0.25 +/- 0.34 mg/dL, P = 0.64; By NCEP-ATP III, 0.28 +/- 0.33 mg/dL vs 0.22 +/- 0.32 mg/dL, P = 0.41). Uric acid and homocysteine levels were higher in those with MetS by WHO definition (P < 0.05). Similarly, analyses according to IDF and NCEP ATP III definition showed no significant difference. CONCLUSION: In conclusion, WHO definition of MetS has a stronger relationship with the biochemical markers of coronary heart disease in Korean type 2 diabetes patients.

Citations

Citations to this article as recorded by  
  • Validation of Waist-to-Height Ratio for Predicting Metabolic Syndrome in Patients with Prediabetes (Korean J Obes 2015;24:36-43)
    Ji Min Kim, Bon Jeong Ku
    The Korean Journal of Obesity.2015; 24(3): 177.     CrossRef
  • Validation of Waist-to-Height Ratio for Predicting Metabolic Syndrome in Patients with Prediabetes
    Ji Min Kim, Min Kyung Back, Sang Hyeon Ju, Min Young Shin, Mi Joo Kim, Yeon-hee Park, Kwang-In Park, Kyong-Hye Joung, Hyun Jin Kim, Bon Jeong Ku
    The Korean Journal of Obesity.2015; 24(1): 36.     CrossRef
  • The Effects of U-Health Program on Metabolic Syndrome of Workers
    Hye-Sun Jung, Bokim Lee, Young-Hyun Kwon, Kyu-Ri Min, Su-Young Myung
    Korean Journal of Occupational Health Nursing.2014; 23(1): 47.     CrossRef
  • The Relationship between Factors of Metabolic Syndrome in Korean Adult Males and the Parents' Family History of Diabetes
    Hyung-Su Park, Jin-Gyu Jeong, Jin-Ho Yu
    The Journal of the Korea institute of electronic communication sciences.2013; 8(5): 779.     CrossRef
  • Use of Serum Homocysteine to Predict Cardiovascular Disease in Korean Men with or without Metabolic Syndrome
    Ji Yeon Kang, Ill Keun Park, Ji Young Lee, Sook Hee Sung, Youn Koun Chang, Yoo Kyoung Park, Tae In Choi
    Journal of Korean Medical Science.2012; 27(5): 500.     CrossRef
Case Report
A Typical Case of Fulminant Type 1 Diabetes Mellitus.
Jung Ho Lee, Gwan Pyo Koh, Jung Kyung Yang, Ki Hong Kim, Dong Mi Im, Keun Yong Park
Korean Diabetes J. 2007;31(2):175-179.   Published online March 1, 2007
DOI: https://doi.org/10.4093/jkda.2007.31.2.175
  • 1,892 View
  • 27 Download
  • 1 Crossref
AbstractAbstract PDF
Recently type 1 diabetes with acute onset and no evidence of islet autoantibodies have been showed as "fulminant type 1 diabetes" and as novel subtype of type 1B diabetes. The study was made progress in Japan. We report a typical case of fulminant type 1 diabetes. A 24 years old male to be in good condition visited our hospital because of flu-like symptom, diarrhea, and abdominal discomfort. He has no medical history and family history of diabetes. The level of plasma glucose is 962 mg/dL, serum ketone body 5.8 mmol/L, arterial blood pH 7.111 and he was diagnosed as diabetic ketoacidosis. Anti-GAD antibody and islet cell antibody were negative and HbA1c is 5.5%. All of them were compatible with the diagnostic criteria of fulminant type 1 diabetes. After the patient has been treated with insulin, his symptoms were improved and abnormal laboratory data were normalized. We report this case with a review of the literature.

Citations

Citations to this article as recorded by  
  • A Case of Fulminant Type 1 Diabetes during Pregnancy
    Tae-Seon Oh, Heesoo Jung, Hye Rim Kang, Tae Kyun Kim, Min Jeong Kwon, Soon Hee Lee, Jeong Hyun Park
    The Journal of Korean Diabetes.2016; 17(2): 134.     CrossRef
Original Article
The Effect of cAMP-Elevating Agents on High Glucose-Induced Apoptosis of Isolated Islets of Rat Pancreas.
Gwan Pyo Koh, Kwang Sik Suh, Suk Chon, Seung Joon Oh, Jeong Taek Woo, Sung Woon Kim, Jin Woo Kim, Young Seol Kim, Sun Hee Kwon
Korean Diabetes J. 2004;28(6):490-500.   Published online December 1, 2004
  • 1,175 View
  • 18 Download
AbstractAbstract PDF
BACKGROUND
High glucose-induced apoptosis has been implicated in the loss of beta-cells of the pancreatic islets in animal models of type 2 diabetes. GLP-1 has been shown to reduce apoptosis by the cAMP-dependent mechanism in beta-cells. Other studies have also shown that elevated levels of intracellular cyclic AMP delayed apoptosis in other types of cells. We investigated whether cAMP-elevating agents could suppress the high glucose-induced apoptosis of isolated rat islets. METHODS: Pancreatic islets were isolated from Sprague-Dawley (SD) rats. The expression of phosphodiesterase (PDE) 3 subtypes was investigated by using extracts of freshly isolated islets and analyzing them by RT-PCR. After 2 days of isolation, the islets were cultured in RPMI-1640 media containing 5% FBS with various glucose concentrations (11.1, 16.7 and 27.8 mM), 5x10-6 M forskolin, 2x10-4 M 3-isobutyl-1-methylxanthine (IBMX), 10-5 M cilostazol, and 10-6, 5x10-6 and 10-5 M H-89 for 5 days. The islet apoptosis was measured by a sandwich enzyme-immunoassay using antihistone antibody. RESULTS: Apoptosis was lowest at 11.1 mM glucose concentration, and increased at higher glucose concentrations (1.00 +/- 0.04 A.U. (arbitrary unit) at 11.1 mM, 1.17 +/- 0.12 A.U. at 16.7 mM, and 1.65 +/-0.13 A.U. at 27.8 mM (P <0.05 for 11.1 mM). Both PDE 3A and 3B mRNA were expressed in the islet extracts. In 16.7 and 27.8 mM glucose concentrations, forskolin (P <0.01), IBMX (P <0.05) and cilostazol (P < 0.05) suppressed apoptosis of the islet cells. Protein kinase A (PKA) nhibitor, H-89, did not prevent the inhibition of apoptosis by forskolin. CONCLUSION: These results show that high glucose-induced apoptosis of the cells in rat islet is attenuated by such cAMP-elevating agents as cilostazol. However, cyclic AMP regulation of islet apoptosis may occur via a PKA-independent signaling pathway.

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