- 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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- 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
- Drug/Regimen
- A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus
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Sae Jeong Yang, Kyung Wan Min, Sandeep Kumar Gupta, Joong Yeol Park, Vyankatesh K.Shivane, Pankaj Kumar Agarwal, Doo Man Kim, Yong Seung Kim, Sei Hyun Baik
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Diabetes Metab J. 2021;45(4):606-612. Published online September 9, 2020
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DOI: https://doi.org/10.4093/dmj.2020.0047
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- The purpose of this extension study was to assess the long-term efficacy and safety of gemigliptin 50 mg in patients with type 2 diabetes mellitus (T2DM). Patients with T2DM who had completed the initial 24-week study comparing gemigliptin monotherapy with placebo were eligible to enrol. In the open-label, 28-week extension study, all enrolled patients received gemigliptin, regardless of the treatment received during the initial 24-week study period. The mean reduction±standard deviation (SD) in glycosylated hemoglobin (HbA1c) observed after 24 weeks of treatment (–0.6%±1.1%) was further decreased for the gemi-gemi group and the mean change in HbA1c at week 52 from baseline was –0.9%±1.2% (P<0.0001). For the pbo-gemi group, HbA1c decreased after they were switched to gemigliptin, and the mean change in HbA1c at week 52 from baseline was –0.7%±1.2% (P<0.0001). Furthermore, the overall incidence of adverse events demonstrated that gemigliptin was safe and well tolerated up to 52 weeks.
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- Efficacy and safety of enavogliflozin versus dapagliflozin added to metformin plus gemigliptin treatment in patients with type 2 diabetes: A double-blind, randomized, comparator-active study: ENHANCE-D study
Kyung-Soo Kim, Kyung Ah Han, Tae Nyun Kim, Cheol-Young Park, Jung Hwan Park, Sang Yong Kim, Yong Hyun Kim, Kee Ho Song, Eun Seok Kang, Chul Sik Kim, Gwanpyo Koh, Jun Goo Kang, Mi Kyung Kim, Ji Min Han, Nan Hee Kim, Ji Oh Mok, Jae Hyuk Lee, Soo Lim, Sang S Diabetes & Metabolism.2023; 49(4): 101440. CrossRef
- Clinical Diabetes & Therapeutics
- Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial
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Tae Jung Oh, Jae Myung Yu, Kyung Wan Min, Hyun Shik Son, Moon Kyu Lee, Kun Ho Yoon, Young Duk Song, Joong Yeol Park, In Kyung Jeong, Bong Soo Cha, Yong Seong Kim, Sei Hyun Baik, In Joo Kim, Doo Man Kim, Sung Rae Kim, Kwan Woo Lee, Jeong Hyung Park, In Kyu Lee, Tae Sun Park, Sung Hee Choi, Sung Woo Park
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Diabetes Metab J. 2019;43(3):276-286. Published online December 7, 2018
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DOI: https://doi.org/10.4093/dmj.2018.0051
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- Background
Combination of metformin to reduce the fasting plasma glucose level and an α-glucosidase inhibitor to decrease the postprandial glucose level is expected to generate a complementary effect. We compared the efficacy and safety of a fixed-dose combination of voglibose plus metformin (vogmet) with metformin monotherapy in drug-naïve newly-diagnosed type 2 diabetes mellitus. MethodsA total of 187 eligible patients aged 20 to 70 years, with a glycosylated hemoglobin (HbA1c) level of 7.0% to 11.0%, were randomized into either vogmet or metformin treatments for 24 weeks. A change in the HbA1c level from baseline was measured at week 24. ResultsThe reduction in the levels of HbA1c was −1.62%±0.07% in the vogmet group and −1.31%±0.07% in the metformin group (P=0.003), and significantly more vogmet-treated patients achieved the target HbA1c levels of <6.5% (P=0.002) or <7% (P=0.039). Glycemic variability was also significantly improved with vogmet treatment, estimated by M-values (P=0.004). Gastrointestinal adverse events and hypoglycemia (%) were numerically lower in the vogmet-treated group. Moreover, a significant weight loss was observed with vogmet treatment compared with metformin (−1.63 kg vs. −0.86 kg, P=0.039). ConclusionVogmet is a safe antihyperglycemic agent that controls blood glucose level effectively, yields weight loss, and is superior to metformin in terms of various key glycemic parameters without increasing the risk of hypoglycemia.
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Mónica Aideé Díaz-Román, Juan José Acevedo-Fernández, Gabriela Ávila-Villarreal, Elizabeth Negrete-León, A. Berenice Aguilar-Guadarrama Fitoterapia.2024; 174: 105839. CrossRef - Efficacy and Safety of DPP-4 Inhibitors and Metformin Combinations in Type 2 Diabetes: A Systematic Literature Review and Network Meta-Analysis
Rongping Chen, Jing Li, Danqi Chen, Weiheng Wen, Susu Zhang, Jitong Li, Yuting Ruan, Zhen Zhang, Jia Sun, Hong Chen Diabetes, Metabolic Syndrome and Obesity.2024; Volume 17: 2471. CrossRef - Metformin-Associated Gastrointestinal Adverse Events Are Reduced by Probiotics: A Meta-Analysis
Izabela Szymczak-Pajor, Józef Drzewoski, Sylwia Wenclewska, Agnieszka Śliwińska Pharmaceuticals.2024; 17(7): 898. CrossRef - YAP/TAZ axis was involved in the effects of metformin on breast cancer
Yu Xu, Hongke Cai, Yuanfeng Xiong, Li Tang, Longjiang Li, Li Zhang, Yi Shen, Yongqiang Yang, Ling Lin, Jiayi Huang Journal of Chemotherapy.2023; 35(7): 627. CrossRef - Diabetes Remission
Ashok Kumar, Shubha Laxmi Margekar, Ravi Kumar Indian Journal of Medical Specialities.2023; 14(1): 3. CrossRef - Analysis of Reports Sent to the Portuguese Pharmacovigilance System and Published Literature Regarding the Safety of Metformin in the Elderly
Beatriz Esteves, Cristina Monteiro, Ana Paula Coelho Duarte Healthcare.2023; 11(15): 2197. CrossRef - Rapid prediction method of α-Glycosidase inhibitory activity of Coreopsis tinctoria extract from different habitats by near infrared spectroscopy
Xiaogang He, Xiang Han, Jiaping Yu, Yulong Feng, Ganghui Chu Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy.2022; 268: 120601. CrossRef - Insulin autoimmune syndrome in patients with type 2 diabetes: A report of two cases
Y. Shin, T.J. Oh, S.H. Choi, H.C. Jang Diabetes & Metabolism.2021; 47(1): 101115. CrossRef - Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung Moon, Sunghwan Suh, Sang Soo Kim, Heung Yong Jin, Jeong Mi Kim, Min Hee Jang, Kyung Ae Lee, Ju Hyung Lee, Seung Min Chung, Young Sang Lyu, Jin Hwa Kim, Sang Yong Kim, Jung Eun Jang, Tae Nyun Kim, Sung Woo Kim, Eonju Jeon, Nan Hee Cho, Mi-Kyung Ki Diabetes & Metabolism Journal.2021; 45(5): 675. CrossRef - Quantifying Remission Probability in Type 2 Diabetes Mellitus
Sanjay Kalra, Ganapathi Bantwal, Nitin Kapoor, Rakesh Sahay, Saptarshi Bhattacharya, Beatrice Anne, Raju A Gopal, Sunil Kota, Ashok Kumar, Ameya Joshi, Debmalya Sanyal, Mangesh Tiwaskar, Ashok Kumar Das Clinics and Practice.2021; 11(4): 850. CrossRef - The effect of voglibose on metabolic profiles in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of clinical trials
Peyman Nowrouzi-Sohrabi, Reza Tabrizi, Shahla Rezaei, Fatemeh Jafari, Kamran Hessami, Mehdi Abedi, Mohammad Jalali, Pedram Keshavarzi, Saeed Shahabi, Ali Asghar Kolahi, Kristin Carson-Chahhoud, Amirhossein Sahebkar, Saeid Safiri Pharmacological Research.2020; 159: 104988. CrossRef - Role of Intestinal Microbiota in Metabolism of Voglibose In Vitro and In Vivo
Mahesh Raj Nepal, Mi Jeong Kang, Geon Ho Kim, Dong Ho Cha, Ju-Hyun Kim, Tae Cheon Jeong Diabetes & Metabolism Journal.2020; 44(6): 908. CrossRef - Response: Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (Diabetes metab J 2019;43;276-86)
Tae Jung Oh, Sung Hee Choi Diabetes & Metabolism Journal.2019; 43(4): 547. CrossRef - Letter: Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (Diabetes Metab J 2019;43;276-86)
Hannah Seok, Tae Seo Sohn Diabetes & Metabolism Journal.2019; 43(4): 545. CrossRef
- Clinical Diabetes & Therapeutics
- Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks
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Soo Lim, Kyoung Min Kim, Sin Gon Kim, Doo Man Kim, Jeong-Taek Woo, Choon Hee Chung, Kyung Soo Ko, Jeong Hyun Park, Yongsoo Park, Sang Jin Kim, Hak Chul Jang, Dong Seop Choi
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Diabetes Metab J. 2017;41(5):377-385. Published online October 24, 2017
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DOI: https://doi.org/10.4093/dmj.2017.41.5.377
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- Background
The aim of this multicenter, randomized, double-blind study was to examine the effect of lobeglitazone, a novel thiazolidinedione, on the changes in bone mineral density (BMD) in patients with type 2 diabetes mellitus. MethodsA 24-week, double-blinded phase was followed by a 28-week, open-label phase, in which the placebo group also started to receive lobeglitazone. A total of 170 patients aged 34 to 76 years were randomly assigned in a 2:1 ratio to receive lobeglitazone 0.5 mg or a matching placebo orally, once daily. BMD was assessed using dual-energy X-ray absorptiometry at week 24 and at the end of the study (week 52). ResultsDuring the double-blinded phase, the femur neck BMD showed decreasing patterns in both groups, without statistical significance (−0.85%±0.36% and −0.78%±0.46% in the lobeglitazone and placebo groups, respectively). The treatment difference between the groups was 0.07%, which was also not statistically significant. Further, minimal, nonsignificant decreases were observed in both groups in the total hip BMD compared to values at baseline, and these differences also did not significantly differ between the groups. During the open-label phase, the BMD was further decreased, but not significantly, by −0.32% at the femur neck and by −0.60% at the total hip in the lobeglitazone group, and these changes did not significantly differ compared with the original placebo group switched to lobeglitazone. ConclusionOur results indicate that treatment with lobeglitazone 0.5 mg over 52 weeks showed no detrimental effect on the BMD compared to the placebo.
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Shashank R. Joshi, Saibal Das, Suja Xaviar, Shambo Samrat Samajdar, Indranil Saha, Sougata Sarkar, Shatavisa Mukherjee, Santanu Kumar Tripathi, Jyotirmoy Pal, Nandini Chatterjee Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(1): 102703. CrossRef - The benefits of adipocyte metabolism in bone health and regeneration
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Balamurugan M, Sarumathy S, Robinson R Cureus.2023;[Epub] CrossRef - A double‐blind, Randomized controlled trial on glucose‐lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase‐4 inhibitor therapy: REFIND study
Soree Ryang, Sang Soo Kim, Ji Cheol Bae, Ji Min Han, Su Kyoung Kwon, Young Il Kim, Il Seong Nam‐Goong, Eun Sook Kim, Mi‐kyung Kim, Chang Won Lee, Soyeon Yoo, Gwanpyo Koh, Min Jeong Kwon, Jeong Hyun Park, In Joo Kim Diabetes, Obesity and Metabolism.2022; 24(9): 1800. CrossRef - A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean Patients with Type 2 Diabetes Mellitus
Bo-Yeon Kim, Hyuk-Sang Kwon, Suk Kyeong Kim, Jung-Hyun Noh, Cheol-Young Park, Hyeong-Kyu Park, Kee-Ho Song, Jong Chul Won, Jae Myung Yu, Mi Young Lee, Jae Hyuk Lee, Soo Lim, Sung Wan Chun, In-Kyung Jeong, Choon Hee Chung, Seung Jin Han, Hee-Seok Kim, Ju-Y Diabetes & Metabolism Journal.2022; 46(6): 855. CrossRef - Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus
Kyung-Soo Kim, Sangmo Hong, Hong-Yup Ahn, Cheol-Young Park Diabetes Therapy.2021; 12(1): 171. CrossRef - Lobeglitazone: A Novel Thiazolidinedione for the Management of Type 2 Diabetes Mellitus
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Won Jun Kim The Journal of Korean Diabetes.2021; 22(2): 97. CrossRef - Use of in vitro bone models to screen for altered bone metabolism, osteopathies, and fracture healing: challenges of complex models
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Guillaume Mabilleau, Béatrice Bouvard Expert Review of Endocrinology & Metabolism.2020; 15(6): 415. CrossRef - The use of metformin, insulin, sulphonylureas, and thiazolidinediones and the risk of fracture: Systematic review and meta‐analysis of observational studies
Khemayanto Hidayat, Xuan Du, Meng‐Jiao Wu, Bi‐Min Shi Obesity Reviews.2019; 20(10): 1494. CrossRef - Diabetes pharmacotherapy and effects on the musculoskeletal system
Evangelia Kalaitzoglou, John L. Fowlkes, Iuliana Popescu, Kathryn M. Thrailkill Diabetes/Metabolism Research and Reviews.2019;[Epub] CrossRef - Morin Exerts Anti‐Arthritic Effects by Attenuating Synovial Angiogenesis via Activation of Peroxisome Proliferator Activated Receptor‐γ
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- Prevalence of Chronic Complications in Korean Patients with Type 2 Diabetes Mellitus Based on the Korean National Diabetes Program
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Sang Youl Rhee, Suk Chon, Mi Kwang Kwon, Ie Byung Park, Kyu Jeung Ahn, In Ju Kim, Sung-Hoon Kim, Hyoung Woo Lee, Kyung Soo Koh, Doo Man Kim, Sei Hyun Baik, Kwan Woo Lee, Moon Suk Nam, Yong Soo Park, Jeong-taek Woo, Young Seol Kim
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Diabetes Metab J. 2011;35(5):504-512. Published online October 31, 2011
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DOI: https://doi.org/10.4093/dmj.2011.35.5.504
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- Background
The Korean National Diabetes Program (KNDP) cohort study is performing an ongoing large-scale prospective multicenter investigation to discover the pathogenesis of type 2 diabetes in Korean patients. This study was performed to examine the prevalence of chronic complications in patients with type 2 diabetes among those registered in the KNDP cohort within the past 4 years. MethodsThis study was performed between June 2006 and September 2009 at 13 university hospitals and included 4,265 KNDP cohort participants. Among the participants, the crude prevalence of microvascular and macrovascular diseases of those checked for diabetes-related complications was determined, and the adjusted standard prevalence and standardization of the general population prevalence ratio (SPR) was estimated based on the 2005 Korean National Health and Nutrition Examination Survey (KNHANES) population demographics. ResultsAmong the KNDP registrants, 43.2% had hypertension, 34.8% had dyslipidemia, 10.8% had macrovascular disease, and 16.7% had microvascular disease. The SPR of the KNDP registrants was significantly higher than that of the KNHANES subjects after adjusting for demographics in the KNHANES 2005 population. However, with the exception of cardiovascular disease in females, the standardized prevalence for the most complicated items in the survey was significantly higher than that in the KNHANES subjects. ConclusionThe prevalence of macrovascular disease and peripheral vascular disease were significantly higher in Korean patients with type 2 diabetes than in the normal population. However, no significant difference was noted in the prevalence of cardiovascular disease in females.
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- Regulation of Glucose Control in People with Type 2 Diabetes: A Review and Consensus
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Jeong-Taek Woo, Kyung Soo Park, Dong-Won Byun, Kyung Soo Ko, Yoon-Sok Chung, Doo Man Kim, Tae Sun Park, Bong Soo Cha, In Kyu Lee, Joong Yeol Park, Hyun Shik Son, Moon-Kyu Lee, Kwang Won Kim, Ho Young Son
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Korean Diabetes J. 2010;34(1):16-20. Published online February 28, 2010
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DOI: https://doi.org/10.4093/kdj.2010.34.1.16
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Abstract
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A conference was convened by the Korean Diabetes Association and the Korean Endocrine Society on September 7, 2009 to discuss and organize the results of research on intensive glucose control for the prevention of cardiovascular disease in patients with type 2 diabetes. Professor Kyung Soo Park led the conference, and Professors Kwang Won Kim and Ho Young Son acted as chairmen. Professors Doo Man Kim, Tae Sun Park, and Bong Soo Cha reported on intensive glucose control and diabetic complications, including the UK Prospective Diabetes Study (UKPDS), Diabetes Control and Complication Trial (DCCT) research results, the recently published Action to Control Cardiovascular Risk in Diabetes (ACCORD), Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE), and Veterans Affairs Diabetes Trial (VADT) research, as well as meta-analyses. Professor Jeong-Taek Woo reported on the manuscript written by the committee for the Korean Diabetes Association which dealt with the treatment of diabetes mellitus. Professors Kyung Soo Ko, Joong Yeol Park, Hyun Shik Son, Moon-Kyu Lee, Dong-Won Byun, and Yoon-Sok Chung participated in the discussion and collected information for the manuscript from all of the participants. The aim of the debate was to determine how to establish target goals for intensive glucose control and how to individualize those goals. The participants concluded that there was no need to modify the recommendation of maintaining an HbA1c under 6.5%, the current blood glucose treatment goal that is recommended by the Korean Diabetes Association. In addition, individual target goals for glucose control were recommended depending on the situation of each patient. We report on the consensus statement from the meeting.
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