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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
Diabetes Metab J. 2024;48(3):418-428.   Published online February 2, 2024
DOI: https://doi.org/10.4093/dmj.2023.0030
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  • 324 Download
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AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
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.

Citations

Citations to this article as recorded by  
  • 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
Article image
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
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
Diabetes Metab J. 2023;47(6):796-807.   Published online February 9, 2023
DOI: https://doi.org/10.4093/dmj.2022.0315
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  • 726 Download
  • 7 Web of Science
  • 8 Crossref
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
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.

Citations

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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
Ji-Eun Jang, Yongin Cho, Byung Wan Lee, Ein-Soon Shin, Sun Hee Lee
Diabetes Metab J. 2019;43(3):302-318.   Published online November 19, 2018
DOI: https://doi.org/10.4093/dmj.2018.0062
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  • 14 Web of Science
  • 16 Crossref
AbstractAbstract PDFSupplementary MaterialPubReader   
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.

Methods

Cochrane, 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.

Results

We 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.

Conclusion

Exercise 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.

Citations

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  • A Feasibility Study of a Web Application Intervention for Persons With Uncontrolled Diabetes
    Atchara Meenasantirak, Chalee Siripitakchai, Natthawut Suriya
    Health Promotion Journal of Australia.2025;[Epub]     CrossRef
  • Effect of low-volume combined aerobic and resistance high-intensity interval training on vascular health in people with type 2 diabetes: a randomised controlled trial
    Emily R. Cox, Trishan Gajanand, Shelley E. Keating, Matthew D. Hordern, Nicola W. Burton, Daniel J. Green, Joyce S. Ramos, Maximiano V. Ramos, Robert G. Fassett, Stephen V. Cox, Jeff S. Coombes, Tom G. Bailey
    European Journal of Applied Physiology.2024; 124(9): 2819.     CrossRef
  • 2023 Clinical Practice Guidelines for Diabetes Management in Korea: Full Version Recommendation of the Korean Diabetes Association
    Jun Sung Moon, Shinae Kang, Jong Han Choi, Kyung Ae Lee, Joon Ho Moon, Suk Chon, Dae Jung Kim, Hyun Jin Kim, Ji A Seo, Mee Kyoung Kim, Jeong Hyun Lim, Yoon Ju Song, Ye Seul Yang, Jae Hyeon Kim, You-Bin Lee, Junghyun Noh, Kyu Yeon Hur, Jong Suk Park, Sang
    Diabetes & Metabolism Journal.2024; 48(4): 546.     CrossRef
  • Exercise as a Therapeutic Intervention for Chronic Disease Management: A Comprehensive Review
    Maryam Fairag, Saif A Alzahrani, Naif Alshehri, Arjwan O Alamoudi, Yazeed Alkheriji, Omar A Alzahrani, Abdulrahman M Alomari, Yahya A Alzahrani, Shahad Mohammed Alghamdi, Amer Fayraq
    Cureus.2024;[Epub]     CrossRef
  • The anti-inflammatory effects of aerobic exercise training in patients with type 2 diabetes: A systematic review and meta-analysis
    Georgia Papagianni, Chrystalla Panayiotou, Michail Vardas, Nikolaos Balaskas, Constantinos Antonopoulos, Dimitrios Tachmatzidis, Triantafyllos Didangelos, Vaia Lambadiari, Nikolaos P.E. Kadoglou
    Cytokine.2023; 164: 156157.     CrossRef
  • Glucose Control in Korean Patients with Type 2 Diabetes Mellitus according to Body Mass Index
    Ye-lim Shin, Heesoh Yoo, Joo Young Hong, Jooeun Kim, Kyung-do Han, Kyu-Na Lee, Yang-Hyun Kim
    Journal of Obesity & Metabolic Syndrome.2023; 32(1): 55.     CrossRef
  • Exercise therapy for diabetes mellitus
    Chaiho Jeong, Tae-Seo Sohn
    Journal of the Korean Medical Association.2023; 66(7): 427.     CrossRef
  • Effects of an evidence‐based nursing intervention on prevention of anxiety and depression in the postpartum period
    Jun Meng, Junying Du, Xiaoli Diao, Yingxia Zou
    Stress and Health.2022; 38(3): 435.     CrossRef
  • Effect of exercise intervention dosage on reducing visceral adipose tissue: a systematic review and network meta-analysis of randomized controlled trials
    Yu-Hsuan Chang, Hui-Ying Yang, Shiow-Ching Shun
    International Journal of Obesity.2021; 45(5): 982.     CrossRef
  • Development and validation of the type 2 diabetes mellitus 10-year risk score prediction models from survey data
    Gregor Stiglic, Fei Wang, Aziz Sheikh, Leona Cilar
    Primary Care Diabetes.2021; 15(4): 699.     CrossRef
  • Pioglitazone for NAFLD Patients With Prediabetes or Type 2 Diabetes Mellitus: A Meta-Analysis
    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
    María Cristina Arrieta-Leandro, Jessenia Hernández-Elizondo, Judith Jiménez-Díaz
    Human Movement.2021; 24(1): 32.     CrossRef
  • Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes Mellitus: A Position Statement of the Fatty Liver Research Group of the Korean Diabetes Association
    Byung-Wan Lee, Yong-ho Lee, Cheol-Young Park, Eun-Jung Rhee, Won-Young Lee, Nan-Hee Kim, Kyung Mook Choi, Keun-Gyu Park, Yeon-Kyung Choi, Bong-Soo Cha, Dae Ho Lee
    Diabetes & Metabolism Journal.2020; 44(3): 382.     CrossRef
  • Beneficial effect of anti-diabetic drugs for nonalcoholic fatty liver disease
    Kyung-Soo Kim, Byung-Wan Lee
    Clinical and Molecular Hepatology.2020; 26(4): 430.     CrossRef
  • Factors Influencing Glycemic Control among Type 2 Diabetes Mellitus Patients: The Sixth Korea National Health and Nutrition Examination Survey (2013~2015)
    Mee Ock Gu
    Korean Journal of Adult Nursing.2019; 31(3): 235.     CrossRef
Editorial
Latent Autoimmune Diabetes in Adults: Autoimmune Diabetes in Adults with Slowly Progressive β-cell Failure
Hannah Seok, Byung Wan Lee
Diabetes Metab J. 2012;36(2):116-119.   Published online April 17, 2012
DOI: https://doi.org/10.4093/dmj.2012.36.2.116
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Citations

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  • CLINICAL AND IMMUNOLOGICAL ASPECTS OF VERIFICATION OF LATENT AUTOIMMUNE DIABETES IN ADULTS AT EARLY STAGES OF DISEASE MANIFESTATION
    Tetiana М. Tykhonova, Igor V. Belozоrov, Nadiya Ye. Barabash, Larysa O. Martymianova
    Wiadomości Lekarskie.2021; 74(7): 1707.     CrossRef
  • Clinical characteristics and insulin independence of Koreans with new‐onset type 2 diabetes presenting with diabetic ketoacidosis
    H. Seok, C. H. Jung, S. W. Kim, M. J. Lee, W. J. Lee, J. H. Kim, B‐W. Lee
    Diabetes/Metabolism Research and Reviews.2013; 29(6): 507.     CrossRef
  • A Case of Latent Autoimmune Diabetes in Adults Developed after Surgical Cure of Growth Hormone Secreting Pituitary Tumor
    Wonjin Kim, Jung Ho Kim, Youngsook Kim, Ji Hye Huh, Su Jin Lee, Mi Sung Park, Eun Yeong Choe, Jeong Kyung Park, Myung Won Lee, Jae Won Hong, Byung Wan Lee, Eun Seok Kang, Bong Soo Cha, Eun Jig Lee, Hyun Chul Lee
    Endocrinology and Metabolism.2012; 27(4): 318.     CrossRef
Original Articles
Effects of Type 2 Diabetes Mellitus on Risk Factors of Acute Coronary Syndrome.
Hong Ju Moon, Jun Goo Kang, Min Ho Jo, Byung Wan Lee, Cheol Young Park, Seong Jin Lee, Eun Kyung Hong, Jae Myoung Yu, Doo Man Kim, Sung Hee Ihm, Hyun Kyu Kim, Chong Yun Rhim, Moon Gi Choi, Hyung Joon Yoo, Sung Woo Park
Korean Diabetes J. 2006;30(6):435-441.   Published online November 1, 2006
DOI: https://doi.org/10.4093/jkda.2006.30.6.435
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AbstractAbstract PDF
BACKGROUND
Diabetes mellitus (DM) is equivalent as well a risk factor of cardiovascular disease. We analyzed the effects of DM on clinical risk factors of acute coronary syndrome by comparing DM group with Non-DM group. METHODS: A total of 847 (514 males and 333 females) patients with acute coronary syndrome was selected from 1664 patients who had undergone coronary angiography (CAG). These patients comprised 105 subjects with non-ST elevation myocardial infarction (MI), 313 with ST elevation MI and 429 with unstable angina. According to the presence of DM, we retrospectively reviewed the measured basic demographics, biochemical markers and coronary angiographic findings. RESULTS: In the multivariated analysis, history of hypertension (P = 0.001), C-reactive protein (CRP) level (P = 0.001) and triglyceride level (P = 0.018) were independent risk factors in type 2 diabetic group. Also the frequency of multiple coronary vessel disease was higher in DM group than non-DM group on the coronary angiographic finding CONCLUSIONS: Classic risk factors for acute coronary syndrome are strong predictors in patients with type 2 DM. Among these factors, the most important powerful risk factor is history of hypertension.

Citations

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  • Gender-Based Differences in the Management and Prognosis of Acute Coronary Syndrome in Korea
    Hee Tae Yu, Kwang Joon Kim, Woo-Dae Bang, Chang-Myung Oh, Ji-Yong Jang, Sung-Soo Cho, Jung-Sun Kim, Young-Guk Ko, Donghoon Choi, Myeong-Ki Hong, Yangsoo Jang
    Yonsei Medical Journal.2011; 52(4): 562.     CrossRef
Effective Glycemic Control Achieved by the Transplantation of VEGF-Transfected Islets in STZ-induced Diabetic Mice.
Byung Wan Lee, Hee Young Chae, You Ran Ahn, Seung Hoon Oh, Ji Youn Kim, Yun Jae Chung, Sang Young Kim, Kyun Yung Cho, Jae Hoon Chung, Yong Ki Min, Myung Shik Lee, Moon Kyu Lee, Kwang Won Kim
Korean Diabetes J. 2005;29(4):282-294.   Published online July 1, 2005
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AbstractAbstract PDF
BACKGROUND
Hypoxic damage is one of the major causes of early islet graft failure, and VEGF is known to play a crucial role in revascularization. We tried to evaluate whether the VEGF transgene in an islet graft can increase islet revascularization and; therefore, increase the survival rate of transplanted islets in order to achieve effective glycemic control in diabetic mice models using a non-viral cationic lipid reagent for gene delivery into non- dividing islet cells. METHODS: Human VEGF165 cDNA was transfected into Balb/c mice islets using Effectene, and the vascular neogenesis and glucose levels examined in the recipient syngeneic Balb/c mice. A minimal number of VEGF-transfected islets(100 IEQ/animal) were transplanted into STZ-induced diabetic mice. The recipient mice were classified into three groups: islet transplantation(IT) without intervention(IT-alone group, n=8), IT with an islets transduced rhoJDK-control vector(IT-rhoJDK group, n=8), and IT with an islets transduced rhoJDK-VEGF vector(IT-rhoJDK-VEGF group, n=8). RESULTS: The transfection efficiency was highest with 4microgram/microliter cDNA and 25microliter Effectene(1: 6 weight ratio), with satisfactory cell viability under these conditions. The overproductions of VEGF mRNA and proteins from the conditioned cells were confirmed. A minimal number of the VEGF-transfected islets(100 IEQ/animal) were transplanted into STZ-induced diabetic mice. The control of hyperglycemia in the IT-alone(0/8) and IT-rhoJDK groups(0/8) failed. However, complete abrogation of hyperglycemia and viable islets, and an increased vascularization of the VEGF-transfected grafts were identified in the renal capsules of the IT-rhoJDK-VEGF group(8/8). CONCLUSION: These studies support the utility of VEGF-transfected islet delivery using a cationic lipid reagent to achieve euglycemia with minimal islets via neovascularization.
Induction of Tolerance to Complete Histocompatibility Mismatched Mice Islets through the Co-transplantation of Bone Marrow Cells in a Minimal Nonmyeloablative Condition.
Ji In Lee, Seung Hoon Oh, You Ran Ahn, Hee Young Chae, Byung Wan Lee, Jae Hoon Chung, Yong Ki Min, Myung Shik Lee, Moon Kyu Lee, Kwang Won Kim
Korean Diabetes J. 2005;29(2):103-111.   Published online March 1, 2005
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AbstractAbstract PDF
BACKGROUND
Islet transplantation(IT) is a therapeutic approach that is used to prevent the dreaded diabetes complications that occur in those patients having an insulin deficient state. However, the requirement of undergoing a lifelong immunosuppressive regimen, along with the related side effects, to prevent rejection of the graft restricts this from being the preferred treatment for type 1 diabetes. One of the strategies to overcome these limitations is to induce tolerance induction and graft acceptance through the process of hematopoietic chimerism. In this study we investigated whether tolerance to MHC-disparate and minor-disparate islet allografts could be induced by the simultaneous transplantation of islets and bone marrow cells(BMCs) under a minimal nonmyeloablative conditioning state. METHODS: The donor and recipient mice are BALB/c(H-2b) and C57BL/6(H-2d) mice, respectively. The streptozotocin induced diabetic C57BL/6(H-2d) mice received only 500 islets from the BALB/c(H-2b) mice in group 1. The group 2 recipients were conditioned with anti- lymphocyte serum(ALS), and 100cGy total body irradiation(TBI), and they were given islet cells of the BALB/c(H-2b) mice, but the group 3 mice were simultaneously given 30x106 BALB/c(H-2b) mice BMCs and islet cells in same condition as group 2. The chimerism of donor derived cells was analyzed by flow cytometry(FACS). Daily monitoring of blood glucose and immunohistochemical staining of the transplanted islets were used to assess the islet graft rejection and the islets' function. RESULTS: We obtained 5~6% allogeneic donor chimerism and 60% of the grafts survived at 80 days after islet transplantation, Additionally, we found infiltration of lymphocytes around the islet without destruction of the endocrine cells, and the presence of vivid insulin/ glucagon stained-cells was detected in group 3. CONCLUSION: This minimal nonmyeloablative conditioning therapy induced the donor's chimerism and immune tolerance between the MHC- and minor-disparate(BALB/c-->C57BL/6) mice. Long-term islet graft survival was obtained through the co-transplantation of BMCs in the mouse model
Effect of Pancreatic Islet Autotransplantation after Pacreatectomy in Patients with Benign Pancreatic Tumor.
Jae Hwan Jee, Byung Wan Lee, Seung Hoon Oh, Ji Youn Kim, Hyun Jin Kim, Jung Hyun Noh, Sung Ho Choi, Jae Hoon Chung, Yong Ki Min, Myung Sik Lee, Moon Kyu Lee, Kwang Won Kim
Korean Diabetes J. 2004;28(2):88-100.   Published online April 1, 2004
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AbstractAbstract PDF
BACKGROUND
Previously, in patients suffering from insulin deficient DM after a partial or total pancreatectomy as treatment for a benign pancreatic tumor, insulin treatment has only led to severe fluctuation in the blood glucose level, and frequently to sudden hypoglycemia due to glucagon deficiency and lack of delicate insulin control. Several worldwide reports have suggested that autologous transplantation of islet cells isolated from an unaffected portion of a resected pancreas, mostly for the cure of chronic pancreatitis or a pancreatic tumor without immunosuppressive agent treatment, resulted in good glycemic control, and even in the prevention of DM. Attempts were made to evaluate the effect of islet autotrans-plantation for glycemic control in eight patients undergoing a pancreatectomy for a benign pancreatic tumor. METHOD: Between December 2001 and October 2003, an islet autotransplantation was performed in eight patients patholologically confirmed with benign pancreatic tumors following a pancreatectomy. There was no past medical history of DM in any of the patients, but impaired glucose tolerance(IGT) was detected in 2 patients on a 75g oral glucose tolerance test(oral GTT), and was also suspected in a pre-pancreatectomy state patient. Islets were isolated by ductal perfusion, using the cold collagenase P and semi-automated method, and purified on a density gradients using a COBE 2991 cell processor or tube system of Ficoll solution. After being confirmed as a benign pancreatic tumor, the cultured islet cells were transplanted to the liver through the portal vein. Each patient was transplanted with a mean islet mass of 3,190+/-896 islet equivalents per kilogram of body weight. The median follow-up period was 12 months, with the longest being 36 months. All patients underwent follow-up for oral GTT, HbA1c and complication of DM, pancreatectomy, or transplantation within this period. RESULTS: On the 75g oral GTT, a normal glucose tolerance(NGT) was maintained until the last follow-up month in five of the eight patients undergoing islet autotransplantation. DM recurred in three of the eight patients undergoing islet autotransplantation, with to cases in a state of IGT and 1 case of NGT at the initial stage. The HbA1c levels were not significantly changed between pre-pancreatectomy and post-islet transplantation period. The amplitude of the decrease in the postprandial 2 hour glucose level was larger than that of the fasting glucose level between the pre- and post-transplantation periods, but this was not statistically. Also, the elevation of the postprandial C-peptide level was larger than the fasting C-peptide during the post-transplantation period, but again, this was not significant. No complications occurred in relation with the islet transplantation, portography, DM and hypoglycemia. CONCLUSION: Islet transplantation could prevent and reverse the diabetic process in patients undergoing a pancreatectomy for a benign pancreatic tumor, with some exception such as those with a small transplanted islet mass or with initial insulin resistance. The 2 hour postprandial changes in the glucose and C- peptide levels on the oral GTT somewhat reflected insulin secretory function of the remaining and newly transplanted islet cells. Pancreatic islet autotransplantation is the most prospective method for the prevention or cure of insulin deficient DM following a pancreatectomy for a benign pancreatic tumor.
Insulin Secretory Dysfunction in the Pathogenesis of Type 2 Diabetes in Koreans: A Minimal Model Analysis.
Sung Hoon Kim, Dong Jun Kim, Byung Wan Lee, In Ah Seo, Jae Hoon Chung, Young Ki Min, Myung Shik Lee, Kwang Won Kim, Moon Kyu Lee
Korean Diabetes J. 2003;27(5):414-419.   Published online October 1, 2003
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AbstractAbstract PDF
BACKGROUND
Type 2 diabetes is a complex, heterogeneous disorder, characterized by impairments in both insulin secretion and insulin action. This study was done to examine the significance of alterations in insulin sensitivity and beta-cell function in the pathogenesis of type 2 diabetes in Korean subjects with varying degrees of glucose intolerance. METHODS: Forty Korean subjects were studied, 12 with normal glucose tolerance (NGT), 14 with impaired glucose tolerance (IGT) and 14 with type 2 diabetes. An oral glucose tolerance test (OGTT) was performed on each subject. Insulin sensitivity (SI), glucose effectiveness (Sg), acute insulin response after intravenous glucose (AIRg) and the disposition index (DI= SI x AIRg) were measured by the insulin-modified, frequently sampled intravenous glucose tolerance test (FSIGT). RESULTS: Neither fasting serum insulin level nor SI was significantly different among the NGT, lGT and diabetes groups. Sg was significantly lower in the type 2 diabetes group than in the NGT group. The mean AIRg was blunted in the IGT and diabetes groups when compared with the NGT group. DI was more powerful in differentiating between NGT and IGT, compared to AIRg alone. CONCLUSION: These findings suggest that a defect in the compensatory insulin secretion might be more important than insulin resistance in the development of type 2 diabetes in Korean subjects.
The Effect of Step-wised, Controlled Cooling Method for Islet Cryopreservation on the in vivo and in vitro Islet Function.
In Kyung Jeong, Seung Hoon Oh, Byung Joon Kim, Tae Young Yang, Byung Wan Lee, Chang Young Ha, Jung Hyung Noh, Jae Hoon Chung, Young Ki Min, Myung Shik Lee, Moon Kyu Lee, Kwang Won Kim
Korean Diabetes J. 2002;26(1):65-74.   Published online February 1, 2002
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AbstractAbstract PDF
BACKGROUND
Although islet transplantation has been attempted to reverse the state of diabetes, achieving a critical number of islets and modulating the immune response limit the success ofl islet transplantation. Cryo-preservation of islets offers many important benefits for islet transplantation by collecting islets with a wide variety of HLA phenotypes and islet MHC expression. The aims of this study was to determine the optimal conditions for cryo-preservation by using a controlled cooling method and to evaluate in vitro and in vivo functional properties of the cryo-preserved islets. METHODS: Collagenase-isolated, Ficoll-purified islets were cultured for 48 hours. They were aliquoted into freezing tubes (1000 islets per tube), equilibrated with 2 M dimethyl sulfoxide (DMSO) in three steps, supercooled, nucleated, and controll- cooled at rate of 0.25 degrees C/min to - 40 degrees C prior to storage at - 196 degrees C. Rapid thawing and removal of DMSO with 0.75 M sucrose preceded 48 hour of culture and the morphology, viability, glucose-induced insulin secretion, and in vivo function of rats transplanted with cryopreserved islets was reexamined. RESULTS: 1) Recovery was 90.2+/-0.2%, 85.7+/-0.1% and 81.7+/-0.1% immediately after, 24 hours and 72 hours after thawing respectively. The viability was 60+/-5%, 80+/-5%, 90+/-5% immediately after, 24 hours and 72 hours after thawing respectively. 2) The glucose-stimulated-insulin secretion (GSIS) tended to decrease immediately after thawing, but GSIS increased to the level of pre-cryopreservation 72 hours after thawing. 3) The in dynamic GSIS, the first and the second phase of insulin secretion were well preserved in islets cultured for 72 hours after thawing. 4) The cryopreserved islets were cultured for 3 days and transplanted into renal sub-capsular space of streptozotocin (STZ) induced diabetic rats. The duration of normoglycemia in the STZ-induced diabetic rats transplanted with cryopreserved islets was significantly longer than that of the fresh islets. CONCLUSION: The optimal condition of cryopreservation using the controlled cooling method was established in rat pancreatic islets. This cryopreservation method can be a feasible approach for human islet transplantation.

Diabetes Metab J : Diabetes & Metabolism Journal
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