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Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon Kim, Jun-Seop Shin, Byoung-Hoon Min, Jong-Min Kim, Chung-Gyu Park, Hee-Jung Kang, Eung Soo Hwang, Won-Woo Lee, Jung-Sik Kim, Hyun Je Kim, Iov Kwon, Jae Sung Kim, Geun Soo Kim, Joonho Moon, Du Yeon Shin, Bumrae Cho, Heung-Mo Yang, Sung Joo Kim, Kwang-Won Kim
Received August 7, 2023  Accepted January 17, 2024  Published online May 21, 2024  
DOI: https://doi.org/10.4093/dmj.2023.0260    [Epub ahead of print]
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AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans.
Methods
A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness.
Conclusion
A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.
Drug/Regimen
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Efficacy and Safety of Self-Titration Algorithms of Insulin Glargine 300 units/mL in Individuals with Uncontrolled Type 2 Diabetes Mellitus (The Korean TITRATION Study): A Randomized Controlled Trial
Jae Hyun Bae, Chang Ho Ahn, Ye Seul Yang, Sun Joon Moon, Soo Heon Kwak, Hye Seung Jung, Kyong Soo Park, Young Min Cho
Diabetes Metab J. 2022;46(1):71-80.   Published online June 16, 2021
DOI: https://doi.org/10.4093/dmj.2020.0274
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  • 1 Web of Science
  • 3 Crossref
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
To compare the efficacy and safety of two insulin self-titration algorithms, Implementing New Strategies with Insulin Glargine for Hyperglycemia Treatment (INSIGHT) and EDITION, for insulin glargine 300 units/mL (Gla-300) in Korean individuals with uncontrolled type 2 diabetes mellitus (T2DM).
Methods
In a 12-week, randomized, open-label trial, individuals with uncontrolled T2DM requiring basal insulin were randomized to either the INSIGHT (adjusted by 1 unit/day) or EDITION (adjusted by 3 units/week) algorithm to achieve a fasting self-monitoring of blood glucose (SMBG) in the range of 4.4 to 5.6 mmol/L. The primary outcome was the proportion of individuals achieving a fasting SMBG ≤5.6 mmol/L without noct urnal hypoglycemia at week 12.
Results
Of 129 individuals (age, 64.1±9.5 years; 66 [51.2%] women), 65 and 64 were randomized to the INSIGHT and EDITION algorithms, respectively. The primary outcome of achievement was comparable between the two groups (24.6% vs. 23.4%, P=0.876). Compared with the EDITION group, the INSIGHT group had a greater reduction in 7-point SMBG but a similar decrease in fasting plasma glucose and glycosylated hemoglobin. The increment of total daily insulin dose was significantly higher in the INSIGHT group than in the EDITION group (between-group difference: 5.8±2.7 units/day, P=0.033). However, body weight was significantly increased only in the EDITION group (0.6±2.4 kg, P=0.038). There was no difference in the occurrence of hypoglycemia between the two groups. Patient satisfaction was significantly increased in the INSIGHT group (P=0.014).
Conclusion
The self-titration of Gla-300 using the INSIGHT algorithm was effective and safe compared with that using the EDITION algorithm in Korean individuals with uncontrolled T2DM (ClinicalTrials.gov number: NCT03406663).

Citations

Citations to this article as recorded by  
  • Basal insulin titration algorithms in patients with type 2 diabetes: the simplest is the best (?)
    V.I. Katerenchuk
    INTERNATIONAL JOURNAL OF ENDOCRINOLOGY (Ukraine).2023; 19(1): 72.     CrossRef
  • Issues of insulin therapy for type 2 diabetes and ways to solve them
    V.I. Katerenchuk, A.V. Katerenchuk
    INTERNATIONAL JOURNAL OF ENDOCRINOLOGY (Ukraine).2023; 19(3): 240.     CrossRef
  • Time for Using Machine Learning for Dose Guidance in Titration of People With Type 2 Diabetes? A Systematic Review of Basal Insulin Dose Guidance
    Camilla Heisel Nyholm Thomsen, Stine Hangaard, Thomas Kronborg, Peter Vestergaard, Ole Hejlesen, Morten Hasselstrøm Jensen
    Journal of Diabetes Science and Technology.2022; : 193229682211459.     CrossRef
Clinical Diabetes and Therapeutics
Hospital-Based Korean Diabetes Prevention Study: A Prospective, Multi-Center, Randomized, Open-Label Controlled Study
Sang Youl Rhee, Suk Chon, Kyu Jeung Ahn, Jeong-Taek Woo
Diabetes Metab J. 2019;43(1):49-58.   Published online November 2, 2018
DOI: https://doi.org/10.4093/dmj.2018.0033
  • 5,539 View
  • 134 Download
  • 11 Web of Science
  • 13 Crossref
AbstractAbstract PDFPubReader   
Background

The prevalence of diabetes mellitus (DM) continues to increase, and the disease burden is the highest of any medical condition in Korea. However, large-scale clinical studies have not yet conducted to establish the basis for diabetes prevention in Korea.

Methods

The hospital-based Korean Diabetes Prevention Study (H-KDPS) is a prospective, multi-center, randomized, open-label controlled study conducted at university hospitals for the purpose of gathering data to help in efforts to prevent type 2 DM. Ten university hospitals are participating, and 744 subjects will be recruited. The subjects are randomly assigned to the standard care group, lifestyle modification group, or metformin group, and their clinical course will be observed for 36 months.

Results

All intervention methodologies were developed, validated, and approved by Korean Diabetes Association (KDA) multi-disciplinary team members. The standard control group will engage in individual education based on the current KDA guidelines, and the lifestyle modification group will participate in a professionally guided healthcare intervention aiming for ≥5% weight loss. The metformin group will begin dosing at 250 mg/day, increasing to a maximum of 1,000 mg/day. The primary endpoint of this study is the cumulative incidence of DM during the 3 years after randomization.

Conclusion

The H-KDPS study is the first large-scale clinical study to establish evidence-based interventions for the prevention of type 2 DM in Koreans. The evidence gathered by this study will be useful for enhancing the health of Koreans and improving the stability of the Korean healthcare system (Trial registration: CRIS KCT0002260, NCT02981121).

Citations

Citations to this article as recorded by  
  • Estimating insulin sensitivity and β-cell function from the oral glucose tolerance test: validation of a new insulin sensitivity and secretion (ISS) model
    Joon Ha, Stephanie T. Chung, Max Springer, Joon Young Kim, Phil Chen, Aaryan Chhabra, Melanie G. Cree, Cecilia Diniz Behn, Anne E. Sumner, Silva A. Arslanian, Arthur S. Sherman
    American Journal of Physiology-Endocrinology and Metabolism.2024; 326(4): E454.     CrossRef
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    Myoung Soo Kim, Jung Mi Ryu, Minkyeong Kang, Jiwon Park, Yeh Chan Ahn, Yang Seok Kim
    Journal of Health Informatics and Statistics.2023; 48(1): 36.     CrossRef
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    Juyoung Shin, Joonyub Lee, Taehoon Ko, Kanghyuck Lee, Yera Choi, Hun-Sung Kim
    Journal of Personalized Medicine.2022; 12(11): 1899.     CrossRef
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    Jin-Hee Lee, Suk Chon, Seon-Ah Cha, Sun-Young Lim, Kook-Rye Kim, Jae-Seung Yun, Sang Youl Rhee, Kun-Ho Yoon, Yu-Bae Ahn, Jeong-Taek Woo, Seung-Hyun Ko
    The Korean Journal of Internal Medicine.2021; 36(2): 382.     CrossRef
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    Sang Youl Rhee, Ji Min Sung, Sunhee Kim, In-Jeong Cho, Sang-Eun Lee, Hyuk-Jae Chang
    Diabetes & Metabolism Journal.2021; 45(4): 515.     CrossRef
  • 2021 Clinical Practice Guidelines for Diabetes Mellitus of the Korean Diabetes Association
    Kyu Yeon Hur, Min Kyong Moon, Jong Suk Park, Soo-Kyung Kim, Seung-Hwan Lee, Jae-Seung Yun, Jong Ha Baek, Junghyun Noh, Byung-Wan Lee, Tae Jung Oh, Suk Chon, Ye Seul Yang, Jang Won Son, Jong Han Choi, Kee Ho Song, Nam Hoon Kim, Sang Yong Kim, Jin Wha Kim,
    Diabetes & Metabolism Journal.2021; 45(4): 461.     CrossRef
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    Jin-Hee Lee, Sun-Young Lim, Seon-Ah Cha, Chan-Jung Han, Ah Reum Jung, Kook-Rye Kim, Kun-Ho Yoon, Seung-Hyun Ko
    Diabetes & Metabolism Journal.2021; 45(6): 960.     CrossRef
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    Seung-Hyun Ko
    The Journal of Korean Diabetes.2021; 22(4): 244.     CrossRef
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    Diabetes/Metabolism Research and Reviews.2020;[Epub]     CrossRef
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    Hye Jin Yoo
    Science Editing.2020; 7(2): 201.     CrossRef
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    Nicole Kah Mun Yoong, Jordan Perring, Ralph Jasper Mobbs
    Sensors.2019; 19(23): 5128.     CrossRef
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    Yunjung Cho, Seung-Hwan Lee
    Diabetes & Metabolism Journal.2019; 43(4): 407.     CrossRef
  • Metformin for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus
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Review
Obesity and Metabolic Syndrome
Diabetes Prevention in Australia: 10 Years Results and Experience
James A. Dunbar
Diabetes Metab J. 2017;41(3):160-167.   Published online February 2, 2017
DOI: https://doi.org/10.4093/dmj.2017.41.3.160
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  • 77 Download
  • 12 Web of Science
  • 11 Crossref
AbstractAbstract PDFPubReader   

Clinical trials have demonstrated the efficacy of lifestyle modification for the prevention of type 2 diabetes mellitus but it was achieved at higher cost than can be sustained in routine health services. The first clinical trial to report was the Finnish Diabetes Prevention Study. This paper describes how Australia worked with Finnish colleagues to adapt the findings of that study to achieve a statewide diabetes prevention program. Small evaluative, effectiveness trials have been conducted in a number of countries to see if the results of the clinical trials can be replicated in routine health services. The Australian evaluative trial, Greater Green Triangle Diabetes Prevention Program is described in detail to demonstrate the ingredients for success in moving a program from one country to another. Few countries have managed to scale up from evaluative trials to statewide or national programs. The Australian experience is described in detail including lessons learned about what reduced the effectiveness, particularly the need for policy makers in government, people from the implementing organisation and researchers to work together from the start of the evaluative trial and throughout the first 5 years of a national program.

Citations

Citations to this article as recorded by  
  • Miscarriage, stillbirth and the risk of diabetes in women: A systematic review and meta-analysis
    Qiqi You, Qingqing Jiang, Irakoze Shani, Yiling Lou, Shen Huang, Shiqi Wang, Shiyi Cao
    Diabetes Research and Clinical Practice.2023; 195: 110224.     CrossRef
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    Helen Dallosso, Kamlesh Khunti, Laura J. Gray, Kerry Hulley, Mel Ghaly, Naina Patel, Joe Kai, Navneet Aujla, Melanie J. Davies, Tom Yates
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    Jonathan Stokes, Judith Gellatly, Peter Bower, Rachel Meacock, Sarah Cotterill, Matt Sutton, Paul Wilson
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Original Article
Clinical Care/Education
Insulin Initiation in Insulin-Naïve Korean Type 2 Diabetic Patients Inadequately Controlled on Oral Antidiabetic Drugs in Real-World Practice: The Modality of Insulin Treatment Evaluation Study
Sang Soo Kim, In Joo Kim, Yong Ki Kim, Kun Ho Yoon, Ho Young Son, Sung Woo Park, Yeon Ah Sung, Hong Sun Baek
Diabetes Metab J. 2015;39(6):481-488.   Published online November 25, 2015
DOI: https://doi.org/10.4093/dmj.2015.39.6.481
  • 4,146 View
  • 74 Download
  • 9 Web of Science
  • 11 Crossref
AbstractAbstract PDFPubReader   
Background

The Modality of Insulin Treatment Evaluation (MOTIV) study was performed to provide real-world data concerning insulin initiation in Korean type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control with oral hypoglycemic agents (OHAs).

Methods

This multicenter, non-interventional, prospective, observational study enrolled T2DM patients with inadequate glycemic control (glycosylated hemoglobin [HbA1c] ≥7.0%) who had been on OHAs for ≥3 months and were already decided to introduce basal insulin by their physician prior to the start of the study. All treatment decisions were at the physician's discretion to reflect real-world practice.

Results

A total of 9,196 patients were enrolled, and 8,636 patients were included in the analysis (mean duration of diabetes, 8.9 years; mean HbA1c, 9.2%). Basal insulin plus one OHA was the most frequently (51.0%) used regimen. After 6 months of basal insulin treatment, HbA1c decreased to 7.4% and 44.5% of patients reached HbA1c <7%. Body weight increased from 65.2 kg to 65.5 kg, which was not significant. Meanwhile, there was significant increase in the mean daily insulin dose from 16.9 IU at baseline to 24.5 IU at month 6 (P<0.001). Overall, 17.6% of patients experienced at least one hypoglycemic event.

Conclusion

In a real-world setting, the initiation of basal insulin is an effective and well-tolerated treatment option in Korean patients with T2DM who are failing to meet targets with OHA therapy.

Citations

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    Eun-Gyoung Hong, Kyung-Wan Min, Jung Soo Lim, Kyu-Jeung Ahn, Chul Woo Ahn, Jae-Myung Yu, Hye Soon Kim, Hyun Jin Kim, Won Kim, Dong Han Kim, Hak Chul Jang
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    Abhishek Shrivastava, Jothydev Kesavadev, Viswanathan Mohan, Banshi Saboo, Dina Shrestha, Anuj Maheshwari, Brij Mohan Makkar, Kirtikumar D. Modi, Ashok Kumar Das
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    Minyuan Chen, Puhong Zhang, Yang Zhao, Nadila Duolikun, Linong Ji
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    Won Sang Yoo, Do Hee Kim, Hee Jin Kim, Hyun Kyung Chung
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    Takahisa Hirose, Ching-Chu Chen, Kyu Jeung Ahn, Jacek Kiljański
    Diabetes Therapy.2019; 10(3): 805.     CrossRef
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    Sunghwan Suh, Sun Ok Song, Jae Hyeon Kim, Hyungjin Cho, Woo Je Lee, Byung-Wan Lee
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