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Jae Hyoung Cho  (Cho JH) 10 Articles
Drug/Regimen
Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance
Jun Sung Moon, Nam Hoon Kim, Jin Oh Na, Jae Hyoung Cho, In-Kyung Jeong, Soon Hee Lee, Ji-Oh Mok, Nan Hee Kim, Dong Jin Chung, Jinhong Cho, Dong Woo Lee, Sun Woo Lee, Kyu Chang Won
Diabetes Metab J. 2023;47(1):82-91.   Published online June 20, 2022
DOI: https://doi.org/10.4093/dmj.2021.0356
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AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus.
Methods
This was a post-marketing surveillance study of empagliflozin 10 and 25 mg. Information on adverse events and adverse drug reactions (ADRs) was collected as safety data sets. Available effectiveness outcomes, including glycosylated hemoglobin (HbA1c) level, fasting plasma glucose, body weight, and blood pressure, were assessed.
Results
The incidence rate of ADRs was 5.14% in the safety dataset (n=3,231). Pollakiuria, pruritis genital, and weight loss were the most common ADRs. ADRs of special interest accounted for only 1.18%, and there were no serious events that led to mortality or hospitalization. In the effectiveness data set (n=2,567), empagliflozin significantly reduced the mean HbA1c level and body weight during the study period by –0.68%±1.39% and –1.91±3.37 kg (both P<0.0001), respectively. In addition, shorter disease duration, absence of dyslipidemia, and higher baseline HbA1c levels were identified as the clinical features characteristic of a “responder” to empagliflozin therapy.
Conclusion
Empagliflozin is a safe and potent glucose-lowering drug in routine use among Korean patients with type 2 diabetes mellitus. It is expected to have better glycemic efficacy in Korean patients with poorly controlled type 2 diabetes mellitus.

Citations

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  • Evaluation of Efficacy and Safety of Empagliflozin in Bangladeshi Patients with Type 2 Diabetes Mellitus (EFFISAEM Study)
    Mohammad Saifuddin, Ajit Kumar Paul, Sultana Marufa Shefin, Md. Jahangir Alam, Shahjada Selim, Sunjida Islam, Tanjina Hossain, Sadiqa Tuqan, Nusrat Sultana, Marufa Mustari, Ramen Chandra Basak, Kazi Ali Aftab, Indrajit Prasad, Mohammad Rafiq Uddin, Shoma
    Indian Journal of Endocrinology and Metabolism.2024;[Epub]     CrossRef
  • Comparison of the Pharmacokinetics, Safety, and Tolerability of Two Empagliflozin Formulations in Healthy Korean Subjects
    Xu Jiang, Sungyeun Bae, Deok Yong Yoon, Shin Jung Park, Jaeseong Oh, Joo-Youn Cho, Kyung-Sang Yu
    Drug Design, Development and Therapy.2023; Volume 17: 2137.     CrossRef
  • Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials
    Chun Xing Li, Li Yan Liu, Chen Xiao Zhang, Xu Hua Geng, Si Meng Gu, Yu Qiao Wang, Hua Liu, Qing Xie, Shuo Liang
    Frontiers in Endocrinology.2023;[Epub]     CrossRef
Early Glycosylated Hemoglobin Target Achievement Predicts Clinical Outcomes in Patients with Newly Diagnosed Type 2 Diabetes Mellitus
Joonyub Lee, Jae Hyoung Cho
Diabetes Metab J. 2021;45(4):621-621.   Published online July 30, 2021
DOI: https://doi.org/10.4093/dmj.2021.0119
Corrects: Diabetes Metab J 2021;45(3):337
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  • Dynamic Detection of HbA1c Using a Silicon Nanowire Field Effect Tube Biosensor
    Hang Chen, Lijuan Deng, Jialin Sun, Hang Li, Xiaoping Zhu, Tong Wang, Yanfeng Jiang
    Biosensors.2022; 12(11): 916.     CrossRef
Early Glycosylated Hemoglobin Target Achievement Predicts Clinical Outcomes in Patients with Newly Diagnosed Type 2 Diabetes Mellitus
Joonyub Lee, Jae Hyoung Cho
Diabetes Metab J. 2021;45(3):337-338.   Published online May 25, 2021
DOI: https://doi.org/10.4093/dmj.2021.0078
Correction in: Diabetes Metab J 2021;45(4):621
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  • Evaluation of Left Ventricular Function in Diabetes Patients with Microvascular Disease by Three-Dimensional Speckle Tracking Imaging
    青 周
    Advances in Clinical Medicine.2023; 13(12): 18908.     CrossRef
  • Association of long-term visit-to-visit variability of HbA1c and fasting glycemia with hypoglycemia in type 2 diabetes mellitus
    Chen Long, Yaling Tang, Jiangsheng Huang, Suo Liu, Zhenhua Xing
    Frontiers in Endocrinology.2022;[Epub]     CrossRef
  • Time to Reach Target Glycosylated Hemoglobin Is Associated with Long-Term Durable Glycemic Control and Risk of Diabetic Complications in Patients with Newly Diagnosed Type 2 Diabetes Mellitus: A 6-Year Observational Study (Diabetes Metab J 2021;45:368-78)
    Kyoung Jin Kim, Jimi Choi, Jae Hyun Bae, Kyeong Jin Kim, Hye Jin Yoo, Ji A Seo, Nan Hee Kim, Kyung Mook Choi, Sei Hyun Baik, Sin Gon Kim, Nam Hoon Kim
    Diabetes & Metabolism Journal.2021; 45(4): 617.     CrossRef
Complications
Differences in Clinical Outcomes between Patients with and without Hypoglycemia during Hospitalization: A Retrospective Study Using Real-World Evidence
Jeongmin Lee, Tong Min Kim, Hyunah Kim, Seung-Hwan Lee, Jae Hyoung Cho, Hyunyong Lee, Hyeon Woo Yim, Kun-Ho Yoon, Hun-Sung Kim
Diabetes Metab J. 2020;44(4):555-565.   Published online May 8, 2020
DOI: https://doi.org/10.4093/dmj.2019.0064
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  • 8 Web of Science
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AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background

Some patients admitted to hospitals for glycemic control experience hypoglycemia despite regular meals and despite adhering to standard blood glucose control protocols. Different factors can have a negative impact on blood glucose control and prognosis after discharge. This study investigated risk factors for hypoglycemia and its effects on glycemic control during the hospitalization of patients in the general ward.

Methods

This retrospective study included patients who were admitted between 2009 and 2018. Patients were provided regular meals at fixed times according to ideal body weights during hospitalization. We categorized the patients into two groups: those with and those without hypoglycemia during hospitalization.

Results

Of the 3,031 patients, 379 experienced at least one episode of hypoglycemia during hospitalization (HYPO group). Hypoglycemia occurred more frequently particularly in cases of premixed insulin therapy. Compared with the control group, the HYPO group was older (61.0±16.8 years vs. 59.1±16.5 years, P=0.035), with more females (60.4% vs. 49.6%, P<0.001), lower body mass index (BMI) (23.5±4.2 kg/m2 vs. 25.1±4.4 kg/m2, P<0.001), and higher prevalence of type 1 diabetes mellitus (6.1% vs. 2.6%, P<0.001), They had longer hospital stay (11.1±13.5 days vs. 7.6±4.6 days, P<0.001). After discharge the HYPO group had lower glycosylated hemoglobin reduction rate (−2.0%±0.2% vs. −2.5%±0.1%, P=0.003) and tended to have more frequent cases of cardiovascular disease.

Conclusion

Hypoglycemia occurred more frequently in older female patients with lower BMI and was associated with longer hospital stay and poorer glycemic control after discharge. Therefore, clinicians must carefully ensure that patients do not experience hypoglycemia during hospitalization.

Citations

Citations to this article as recorded by  
  • Acute kidney injury: a strong risk factor for hypoglycaemia in hospitalized patients with type 2 diabetes
    Ana Carreira, Pedro Castro, Filipe Mira, Miguel Melo, Pedro Ribeiro, Lèlita Santos
    Acta Diabetologica.2023; 60(9): 1179.     CrossRef
  • Adherence to healthy lifestyle behaviors as a preventable risk factor for severe hypoglycemia in people with type 2 diabetes: A longitudinal nationwide cohort study
    Jae‐Seung Yun, Kyungdo Han, Yong‐Moon Park, Eugene Han, Yong‐ho Lee, Seung‐Hyun Ko
    Journal of Diabetes Investigation.2022; 13(9): 1533.     CrossRef
  • Predicting hypoglycemia in hospitalized patients with diabetes: A derivation and validation study
    Michal Elbaz, Jeries Nashashibi, Shiri Kushnir, Leonard Leibovici
    Diabetes Research and Clinical Practice.2021; 171: 108611.     CrossRef
  • Hospital care: improving outcomes in type 1 diabetes
    Schafer Boeder, Kristen Kulasa
    Current Opinion in Endocrinology, Diabetes & Obesity.2021; 28(1): 14.     CrossRef
  • Data Pseudonymization in a Range That Does Not Affect Data Quality: Correlation with the Degree of Participation of Clinicians
    Soo-Yong Shin, Hun-Sung Kim
    Journal of Korean Medical Science.2021;[Epub]     CrossRef
  • Letter: Differences in Clinical Outcomes between Patients with and without Hypoglycemia during Hospitalization: A Retrospective Study Using Real-World Evidence (Diabetes Metab J 2020;44:555-65)
    Sung-Woo Kim
    Diabetes & Metabolism Journal.2020; 44(5): 775.     CrossRef
  • Response: Differences in Clinical Outcomes between Patients with and without Hypoglycemia during Hospitalization: A Retrospective Study Using Real-World Evidence (Diabetes Metab J 2020;44:555-65)
    Jeongmin Lee, Hun-Sung Kim
    Diabetes & Metabolism Journal.2020; 44(5): 779.     CrossRef
  • Hypoglycaemia and Cardiovascular Disease Risk in Patients with Diabetes
    Niki Katsiki, Kalliopi Kotsa, Anca P. Stoian, Dimitri P. Mikhailidis
    Current Pharmaceutical Design.2020; 26(43): 5637.     CrossRef
Letter: Effects of High-Dose α-Lipoic Acid on Heart Rate Variability of Type 2 Diabetes Mellitus Patients with Cardiac Autonomic Neuropathy in Korea (Diabetes Metab J 2017;41:275-83)
Jeongmin Lee, Jae Hyoung Cho
Diabetes Metab J. 2017;41(5):417-419.   Published online October 24, 2017
DOI: https://doi.org/10.4093/dmj.2017.41.5.417
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Citations

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  • Efficacy and safety of oral alpha-lipoic acid supplementation for type 2 diabetes management: a systematic review and dose–response meta-analysis of randomized trials
    Aliyu Tijani Jibril, Ahmad Jayedi, Sakineh Shab-Bidar
    Endocrine Connections.2022;[Epub]     CrossRef
  • Long-Term Sleep Deprivation-Induced Myocardial Remodeling and Mitochondrial Dysfunction in Mice Were Attenuated by Lipoic Acid and N-Acetylcysteine
    Fei Song, Jiale Lin, Houjian Zhang, Yuli Guo, Yijie Mao, Zuguo Liu, Gang Li, Yan Wang
    Pharmaceuticals.2022; 16(1): 51.     CrossRef
Clinical Care/Education
Physician-Directed Diabetes Education without a Medication Change and Associated Patient Outcomes
Hun-Sung Kim, Hyunah Kim, Hae-Kyung Yang, Eun Young Lee, Yoo Jin Jeong, Tong Min Kim, So Jung Yang, Seo Yeon Baik, Seung-Hwan Lee, Jae Hyoung Cho, In Young Choi, Hyeon Woo Yim, Bong-Yun Cha
Diabetes Metab J. 2017;41(3):187-194.   Published online May 12, 2017
DOI: https://doi.org/10.4093/dmj.2017.41.3.187
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AbstractAbstract PDFPubReader   
Background

When patients with diabetes mellitus (DM) are first referred to a hospital from primary health care clinics, physicians have to decide whether to administer an oral hypoglycemic agent (OHA) immediately or postpone a medication change in favor of diabetes education regarding diet or exercise. The aim of this study was to determine the effect of diabetes education alone (without alterations in diabetes medication) on blood glucose levels.

Methods

The study was conducted between January 2009 and December 2013 and included patients with DM. The glycosylated hemoglobin (HbA1c) levels were evaluated at the first visit and after 3 months. During the first medical examination, a designated doctor also conducted a diabetes education session that mainly covered dietary management.

Results

Patients were divided into those who received no diabetic medications (n=66) and those who received an OHA (n=124). Education resulted in a marked decrease in HbA1c levels in the OHA group among patients who had DM for <1 year (from 7.0%±1.3% to 6.6%±0.9%, P=0.0092) and for 1 to 5 years (from 7.5%±1.8% to 6.9%±1.1%, P=0.0091). Those with DM >10 years showed a slightly lower HbA1c target achievement rate of <6.5% (odds ratio, 0.089; P=0.0024).

Conclusion

For patients who had DM for more than 5 years, higher doses or changes in medication were more effective than intensive active education. Therefore, individualized and customized education are needed for these patients. For patients with a shorter duration of DM, it may be more effective to provide initial intensive education for diabetes before prescribing medicines, such as OHAs.

Citations

Citations to this article as recorded by  
  • Management Status of Patients with Type 2 Diabetes Mellitus at General Hospitals in Korea: A 5-Year Follow-Up Study
    Jin Hee Jung, Jung Hwa Lee, Hyang Mi Jang, Young Na, Hee Sun Choi, Yeon Hee Lee, Yang Gyo Kang, Na Rae Kim, Jeong Rim Lee, Bok Rye Song, Kang Hee Sim
    The Journal of Korean Diabetes.2022; 23(1): 64.     CrossRef
  • Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial
    Da Young Lee, Seung-Hyun Yoo, Kyong Pil Min, Cheol-Young Park
    JMIR mHealth and uHealth.2020; 8(9): e19153.     CrossRef
  • Developing a multi-center clinical data mart of ACEI and ARB for real-world evidence (RWE)
    Hun-Sung Kim, Sue Hyun Lee, Tong Min Kim, Ju Han Kim
    Clinical Hypertension.2018;[Epub]     CrossRef
Others
Satisfaction Survey on Information Technology-Based Glucose Monitoring System Targeting Diabetes Mellitus in Private Local Clinics in Korea
Hun-Sung Kim, So Jung Yang, Yoo Jin Jeong, Young-Eun Kim, Seok-Won Hong, Jae Hyoung Cho
Diabetes Metab J. 2017;41(3):213-222.   Published online June 21, 2017
DOI: https://doi.org/10.4093/dmj.2017.41.3.213
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AbstractAbstract PDFPubReader   
Background

Private local clinics in Korea have little experience with information technology (IT)-based glucose monitoring (ITGM). Our aim is to examine user satisfaction and the possibility of using ITGM service practically.

Methods

Patients sent their blood glucose levels to physicians in local clinics. The physicians reviewed the blood glucose values online and provided personal consultations through text messaging or phone calls. Thereafter, a satisfaction survey on the ITGM service, the modified Morisky scale, and patient assessment of chronic illness care were administered.

Results

One hundred and seventy patients from seven private local clinics used the ITGM. Overall satisfaction, including that about the ITGM service, the device, and its usefulness, was rated higher than “mostly satisfied” (score 4.2±0.8 out of 5.0) and even higher among the elderly. Satisfaction was positively associated with age, especially in those older than 60 years. The main reason for intent for future use of the service was the time/place flexibility. Highly motivated patients tended to answer positively regarding information satisfaction (P=0.0377).

Conclusion

Our study is the first to investigate ITGM satisfaction in private local clinics. The feasibility of users utilizing ITGM should be clarified, and future clinical research on the service's clinical effects and cost-benefit analysis is needed.

Citations

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  • Exploring Quantitative Methodologies for Assessing the Environmental, Social, and Economic Impacts of Telemedicine: A Literature Review
    Anna Savoldelli, Daniele Landi, Caterina Rizzi
    Sustainability.2024; 16(6): 2438.     CrossRef
  • Telemedicine for Diabetes Mellitus Management in Older Adults: A Systematic Review
    Luca Schiliró Tristão, Guilherme Tavares, Francisco Tustumi, Wanderley Marques Bernardo, Márcio Luis Duarte, Maria Stella Peccin, Lucas Ribeiro dos Santos
    Current Diabetes Reviews.2023;[Epub]     CrossRef
  • The effectiveness of mobile application for monitoring diabetes mellitus and hypertension in the adult and elderly population: systematic review and meta-analysis
    Emily de Souza Ferreira, Fernanda de Aguiar Franco, Marina Marilac dos Santos Lara, André Amaral Levcovitz, Mateus Araújo Dias, Tiago Ricardo Moreira, Ary Henrique Morais de Oliveira, Rosângela Minardi Mitre Cotta
    BMC Health Services Research.2023;[Epub]     CrossRef
  • Effects of the Physician–Primary-Healthcare Nurse Telemedicine Model (P-NTM) on Medication Adherence and Health-Related Quality of Life (HRQoL) of Patients with Chronic Disease at Remote Rural Areas
    Mi Young Kwak, Eun Jeong Hwang, Tae Ho Lee
    International Journal of Environmental Research and Public Health.2021; 18(5): 2502.     CrossRef
  • Lessons from Use of Continuous Glucose Monitoring Systems in Digital Healthcare
    Hun-Sung Kim, Kun-Ho Yoon
    Endocrinology and Metabolism.2020; 35(3): 541.     CrossRef
  • Apprehensions about Excessive Belief in Digital Therapeutics: Points of Concern Excluding Merits
    Hun-Sung Kim
    Journal of Korean Medical Science.2020;[Epub]     CrossRef
  • Peripartum Management of Gestational Diabetes Using a Digital Health Care Service: A Pilot, Randomized Controlled Study
    Ji-Hee Sung, Da Young Lee, Kyoung Pil Min, Cheol-Young Park
    Clinical Therapeutics.2019; 41(11): 2426.     CrossRef
  • Mobile Phone–Based Telemedicine Practice in Older Chinese Patients with Type 2 Diabetes Mellitus: Randomized Controlled Trial
    Chenglin Sun, Lin Sun, Shugang Xi, Hong Zhang, Huan Wang, Yakun Feng, Yufeng Deng, Haimin Wang, Xianchao Xiao, Gang Wang, Yuan Gao, Guixia Wang
    JMIR mHealth and uHealth.2019; 7(1): e10664.     CrossRef
Clinical Care/Education
Potential of OneTouch Diabetes Management Software System in Real Field for Korean Type 2 Diabetes Patients
Borami Kang, Jae Hyoung Cho
Diabetes Metab J. 2016;40(2):115-117.   Published online April 25, 2016
DOI: https://doi.org/10.4093/dmj.2016.40.2.115
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The Insulin Resistance but Not the Insulin Secretion Parameters Have Changed in the Korean Population during the Last Decade
Hae Kyung Yang, Jin Hee Lee, In-Young Choi, Hyuk Sang Kwon, Jeong Ah Shin, Seung Hee Jeong, Seung-Hwan Lee, Jae Hyoung Cho, Ho Young Son, Kun Ho Yoon
Diabetes Metab J. 2015;39(2):117-125.   Published online April 20, 2015
DOI: https://doi.org/10.4093/dmj.2015.39.2.117
  • 4,530 View
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AbstractAbstract PDFPubReader   
Background

This study aimed to compare the patterns of insulin secretion and resistance between Korean subjects in the 1990s and 2000s.

Methods

Insulin secretion and resistance indices were calculated from subjects who underwent 75-g oral glucose tolerance tests in the year 1997 to 1999 and 2007 to 2011 at the Seoul St. Mary's Hospital, Korea.

Results

A total of 578 subjects from the 1990s (mean age, 48.5 years) and 504 subjects from the 2000s (mean age, 50.2 years) were enrolled. Compared with the subjects from the 1990s, those from the 2000s exhibited increased insulin resistance (increased homeostatic model assessment for insulin resistance), and reduced insulin sensitivity (reduced Matsuda index and quantitative insulin sensitivity check index), regardless of their glucose tolerance status. However, insulinogenic index did not reveal significant differences between the 2 decades in subjects with or without diabetes. A distinct relationship was confirmed between Matsuda index and total area under the curve (insulin/glucose) in each glucose tolerance group. The mean product of the Matsuda index and the total area under the curve (insulin/glucose) as well as the oral disposition index, was lower in subjects with normal glucose tolerance from the 2000s than in those from the 1990s.

Conclusion

After rapid economic growth and changes in lifestyle patterns, insulin resistance has worsened across the glucose tolerance status; however, the insulin secretory function remained unchanged, which resulted in an increase in the susceptibility to the development of type 2 diabetes mellitus among Korean subjects without diabetes. We could not rule out the potential selection bias and therefore, further studies in general Korean population are needed.

Citations

Citations to this article as recorded by  
  • Longitudinal Changes in Insulin Resistance, Beta-Cell Function and Glucose Regulation Status in Prediabetes
    Chul-Hee Kim, Hong-Kyu Kim, Eun-Hee Kim, Sung-Jin Bae, Jaewon Choe, Joong-Yeol Park
    The American Journal of the Medical Sciences.2018; 355(1): 54.     CrossRef
  • Association of serum 25-hydroxyvitamin D and diabetes-related factors in Korean adults without diabetes: The Fifth Korea National Health and Nutrition Examination Survey 2010–2012
    Hyunah Kim, Hyunyong Lee, Hyeon Woo Yim, Hun-Sung Kim
    Primary Care Diabetes.2018; 12(1): 59.     CrossRef
  • Long‐term effects on glycaemic control and β‐cell preservation of early intensive treatment in patients with newly diagnosed type 2 diabetes: A multicentre randomized trial
    Suk Chon, Sang Youl Rhee, Kyu Jeung Ahn, Sei Hyun Baik, Yongsoo Park, Moon Suk Nam, Kwan Woo Lee, Soon Jib Yoo, Gwanpyo Koh, Dae Ho Lee, Young Seol Kim, Jeong‐Taek Woo
    Diabetes, Obesity and Metabolism.2018; 20(5): 1121.     CrossRef
  • Four Plasma Glucose and Insulin Responses to a 75 g OGTT in Healthy Young Japanese Women
    Kei Takahashi, Hidetaka Nakamura, Hiroshi Sato, Hideto Matsuda, Kazuo Takada, Tomiko Tsuji
    Journal of Diabetes Research.2018; 2018: 1.     CrossRef
  • Comparison of insulin intensification strategies with insulin lispro low mixture twice daily versus basal insulin glargine and prandial insulin lispro once daily in East Asian and Caucasian patients with type 2 diabetes mellitus
    In‐Kyung Jeong, Choon Hee Chung, Zhiguang Zhou, Jeong Hee Han, Ran Duan, Diana M. Edralin, Angel Rodriguez
    Journal of Diabetes.2017; 9(4): 396.     CrossRef
  • Insulin Secretory Capacity and Insulin Resistance in Korean Type 2 Diabetes Mellitus Patients
    Jong-Dai Kim, Won-Young Lee
    Endocrinology and Metabolism.2016; 31(3): 354.     CrossRef
  • Antisenescence activity of G9a inhibitor BIX01294 on human bone marrow mesenchymal stromal cells
    Min-Ji AHN, Sin-Gu JEONG, Goang-Won CHO
    TURKISH JOURNAL OF BIOLOGY.2016; 40: 443.     CrossRef
  • Urinary N-acetyl-β-D-glucosaminidase, an early marker of diabetic kidney disease, might reflect glucose excursion in patients with type 2 diabetes
    So Ra Kim, Yong-ho Lee, Sang-Guk Lee, Eun Seok Kang, Bong-Soo Cha, Jeong-Ho Kim, Byung-Wan Lee
    Medicine.2016; 95(27): e4114.     CrossRef
Drug/Regimen
Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study
Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park
Received February 3, 2023  Accepted July 10, 2023  Published online February 2, 2024  
DOI: https://doi.org/10.4093/dmj.2023.0030    [Epub ahead of print]
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AbstractAbstract PDFSupplementary MaterialPubReader   
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.

Diabetes Metab J : Diabetes & Metabolism Journal