- Drug/Regimen
- Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study
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Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park
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Diabetes Metab J. 2024;48(3):418-428. Published online February 2, 2024
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DOI: https://doi.org/10.4093/dmj.2023.0030
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- Background
To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM).
Methods This was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015 to May 25, 2021 at 85 Korean healthcare centers using electronic case data. Data on patients using dulaglutide 0.75 mg/0.5 mL or the dulaglutide 1.5 mg/0.5 mL single-use pens were collected and pooled. The primary objective was to report the frequency and proportion of adverse and serious adverse events that occurred. The secondary objective was to monitor the effectiveness of dulaglutide at 12 and 24 weeks by evaluating changes in glycosylated hemoglobin (HbA1c ), fasting plasma glucose, and body weight.
Results Data were collected from 3,067 subjects, and 3,022 subjects who received ≥1 dose (of any strength) of dulaglutide were included in the safety analysis set (53% female, mean age 56 years; diabetes duration 11.2 years, mean HbA1c 8.8%). The number of adverse events reported was 819; of these, 68 (8.3%) were serious adverse events. One death was reported. Adverse events were mostly mild in severity; 60.81% of adverse events were considered related to dulaglutide. This study was completed by 72.73% (2,198/3,022) of subjects. At 12/24 weeks there were significant (P<0.0001) reductions from baseline in least-squares mean HbA1c (0.96%/0.95%), fasting blood glucose (26.24/24.43 mg/dL), and body weight (0.75/1.21 kg).
Conclusion Dulaglutide was generally well tolerated and effective in real-world Korean individuals with T2DM. The results from this study contribute to the body of evidence for dulaglutide use in this population.
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Citations
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- One-year Efficacy and Safety of Dulaglutide in Patients with Type 2 Diabetes and Chronic Kidney Disease: A Retrospective Study of Asian Patients
Myung Jin Kim, Hwi Seung Kim, Yun Kyung Cho, Chang Hee Jung, Woo Je Lee Clinical Therapeutics.2024; 46(9): 683. CrossRef - Safety and Effectiveness of Naltrexone-Bupropion in Korean Adults with Obesity: Post-Marketing Surveillance Study
Young Lyu, Hongyup Ahn, Sangmo Hong, Cheol-Young Park Drug Design, Development and Therapy.2024; Volume 18: 5255. CrossRef
- Drug Regimen
- Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial
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Kyung Ah Han, Yong Hyun Kim, Doo Man Kim, Byung Wan Lee, Suk Chon, Tae Seo Sohn, In Kyung Jeong, Eun-Gyoung Hong, Jang Won Son, Jae Jin Nah, Hwa Rang Song, Seong In Cho, Seung-Ah Cho, Kun Ho Yoon
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Diabetes Metab J. 2023;47(6):796-807. Published online February 9, 2023
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DOI: https://doi.org/10.4093/dmj.2022.0315
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42,469
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- Background
Enavogliflozin is a novel sodium-glucose cotransporter-2 inhibitor currently under clinical development. This study evaluated the efficacy and safety of enavogliflozin as an add-on to metformin in Korean patients with type 2 diabetes mellitus (T2DM) against dapagliflozin.
Methods In this multicenter, double-blind, randomized, phase 3 study, 200 patients were randomized to receive enavogliflozin 0.3 mg/day (n=101) or dapagliflozin 10 mg/day (n=99) in addition to ongoing metformin therapy for 24 weeks. The primary objective of the study was to prove the non-inferiority of enavogliflozin to dapagliflozin in glycosylated hemoglobin (HbA1c) change at week 24 (non-inferiority margin of 0.35%) (Clinical trial registration number: NCT04634500).
Results Adjusted mean change of HbA1c at week 24 was –0.80% with enavogliflozin and –0.75% with dapagliflozin (difference, –0.04%; 95% confidence interval, –0.21% to 0.12%). Percentages of patients achieving HbA1c <7.0% were 61% and 62%, respectively. Adjusted mean change of fasting plasma glucose at week 24 was –32.53 and –29.14 mg/dL. An increase in urine glucose-creatinine ratio (60.48 vs. 44.94, P<0.0001) and decrease in homeostasis model assessment of insulin resistance (–1.85 vs. –1.31, P=0.0041) were significantly greater with enavogliflozin than dapagliflozin at week 24. Beneficial effects of enavogliflozin on body weight (–3.77 kg vs. –3.58 kg) and blood pressure (systolic/diastolic, –5.93/–5.41 mm Hg vs. –6.57/–4.26 mm Hg) were comparable with those of dapagliflozin, and both drugs were safe and well-tolerated.
Conclusion Enavogliflozin added to metformin significantly improved glycemic control in patients with T2DM and was non-inferior to dapagliflozin 10 mg, suggesting enavogliflozin as a viable treatment option for patients with inadequate glycemic control on metformin alone.
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- Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: a pooled analysis of two randomized controlled trials
Young Sang Lyu, Sangmo Hong, Si Eun Lee, Bo Young Cho, Cheol-Young Park Cardiovascular Diabetology.2024;[Epub] CrossRef - A 52‐week efficacy and safety study of enavogliflozin versus dapagliflozin as an add‐on to metformin in patients with type 2 diabetes mellitus: ENHANCE‐M extension study
Tae Seo Sohn, Kyung‐Ah Han, Yonghyun Kim, Byung‐Wan Lee, Suk Chon, In‐Kyung Jeong, Eun‐Gyoung Hong, Jang Won Son, JaeJin Na, Jae Min Cho, Seong In Cho, Wan Huh, Kun‐Ho Yoon Diabetes, Obesity and Metabolism.2024; 26(6): 2248. CrossRef - The effect of renal function on the pharmacokinetics and pharmacodynamics of enavogliflozin, a potent and selective sodium‐glucose cotransporter‐2 inhibitor, in type 2 diabetes
Sae Im Jeong, Mu Seong Ban, Jun‐Gi Hwang, Min‐Kyu Park, Soo Lim, Sejoong Kim, Soon Kil Kwon, Yoonjin Kim, Jae Min Cho, Jae Jin Na, Wan Huh, Jae‐Yong Chung Diabetes, Obesity and Metabolism.2024; 26(7): 2588. CrossRef - Long‐term efficacy and safety of enavogliflozin in Korean people with type 2 diabetes: A 52‐week extension of a Phase 3 randomized controlled trial
Soo Heon Kwak, Kyung Ah Han, Eun Sook Kim, Sung Hee Choi, Jong Chul Won, Jae Myung Yu, Seungjoon Oh, Hye Jin Yoo, Chong Hwa Kim, Kyung‐Soo Kim, SungWan Chun, Yong Hyun Kim, Seung Ah Cho, Da Hye Kim, Kyong Soo Park Diabetes, Obesity and Metabolism.2024; 26(10): 4203. CrossRef - Role of novel sodium glucose co-transporter-2 inhibitor enavogliflozin in type-2 diabetes: A systematic review and meta-analysis
Deep Dutta, B.G. Harish, Beatrice Anne, Lakshmi Nagendra Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(8): 102816. CrossRef - Characteristics of the Latest Therapeutic Agent for Diabetes
Nuri Yun The Journal of Korean Diabetes.2023; 24(3): 148. CrossRef - Prospects of using sodium-glucose co-transporter-2 (SGLT-2) inhibitors in patients with metabolic-associated fatty liver disease (MAFLD)
Iryna Kostitska, Nadia Protas, Liliia Petrovska Diabetes Obesity Metabolic Syndrome.2023; (5): 8. CrossRef - Navigating the Future of Diabetes Treatment with New Drugs: Focusing on the Possibilities and Prospects of Enavogliflozin
Sang Youl Rhee Diabetes & Metabolism Journal.2023; 47(6): 769. CrossRef
- Clinical Diabetes & Therapeutics
- Effectiveness of Exercise Intervention in Reducing Body Weight and Glycosylated Hemoglobin Levels in Patients with Type 2 Diabetes Mellitus in Korea: A Systematic Review and Meta-Analysis
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Ji-Eun Jang, Yongin Cho, Byung Wan Lee, Ein-Soon Shin, Sun Hee Lee
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Diabetes Metab J. 2019;43(3):302-318. Published online November 19, 2018
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DOI: https://doi.org/10.4093/dmj.2018.0062
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- Background
This study aimed to assess the effectiveness of exercise intervention in reducing body weight and glycosylated hemoglobin (HbA1c) level in patients with type 2 diabetes mellitus (T2DM) in Korea. MethodsCochrane, PubMed, Embase, KoreaMed, KMbase, NDSL, KCI, RISS, and DBpia databases were used to search randomized controlled trials and controlled clinical trials that compared exercise with non-exercise intervention among patients with non-insulin-treated T2DM in Korea. The effectiveness of exercise intervention was estimated by the mean difference in body weight changes and HbA1c level. Weighted mean difference (WMD) with its corresponding 95% confidence interval (CI) was used as the effect size. The pooled mean differences of outcomes were calculated using a random-effects model. ResultsWe identified 7,692 studies through literature search and selected 23 articles (723 participants). Compared with the control group, exercise intervention (17 studies) was associated with a significant decline in HbA1c level (WMD, −0.58%; 95% CI, −0.89 to −0.27; I2=73%). Although no significant effectiveness on body weight was observed, eight aerobic training studies showed a significant reduction in body weight (WMD, −2.25 kg; 95% CI, −4.36 to −0.13; I2=17%) in the subgroup analysis. ConclusionExercise significantly improves glycemic control; however, it does not significantly reduce body weight. Aerobic training can be beneficial for patients with non-insulin-treated T2DM in Korea.
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Jingxuan Lian, Jianfang Fu Frontiers in Endocrinology.2021;[Epub] CrossRef - Exercise Training: The Holistic Approach in Cardiovascular Prevention
Francesco Giallauria, Teresa Strisciuglio, Gianluigi Cuomo, Anna Di Lorenzo, Andrea D’Angelo, Mario Volpicelli, Raffaele Izzo, Maria Virginia Manzi, Emanuele Barbato, Carmine Morisco High Blood Pressure & Cardiovascular Prevention.2021; 28(6): 561. CrossRef - Effect of chronic High Intensity Interval Training on glycosylated haemoglobin in people with type 2 diabetes: a meta-analysis
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- Latent Autoimmune Diabetes in Adults: Autoimmune Diabetes in Adults with Slowly Progressive β-cell Failure
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Hannah Seok, Byung Wan Lee
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Diabetes Metab J. 2012;36(2):116-119. Published online April 17, 2012
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DOI: https://doi.org/10.4093/dmj.2012.36.2.116
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