Diabetes & Metabolism Journal

2018

Original Articles

Obesity and Metabolic Syndrome
Prediction of Gestational Diabetes Mellitus in Pregnant Korean Women Based on Abdominal Subcutaneous Fat Thickness as Measured by Ultrasonography: Sung Hee Yang, Changsoo Kim, Hyun Sook An, Hyun An, Jin Soo Lee; Diabetes Metab J. 2017;41(6):486-491. Published online September 22, 2017; DOI: https://doi.org/10.4093/dmj.2017.41.6.486

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Background

This study was performed to verify the correlation between abdominal subcutaneous fat thickness (ASFT) measured by ultrasonography (US) during the first trimester of pregnancy and gestational diabetes mellitus (GDM) of the second trimester in Korean women and to establish a standard of ASFT for predicting GDM.

Methods

A total of 333 singleton pregnant women participated in this study. Their ASFT was measured by US during the 10⁺⁶ to 13⁺⁶ weeks of pregnancy; then a GDM confirmatory test (100 g oral glucose tolerance test) was conducted during the 24 to 28 week period of pregnancy. Based on the GDM tests, comparative analyses of the ages of the subjects, pre-pregnancy body mass index (BMI), and weight gain during pregnancy were conducted.

Results

The ages of the subjects and weight gains during pregnancy were not correlated to the GDM of the second trimester of pregnancy, but the pre-pregnancy BMIs (22±3.3 kg/m²) and the ASFT (1.9±0.5 cm) measurements between the control group and subjects during the first trimester of pregnancy were found to show significant differences (P<0.001). The cut-off value of the ASFT for predicting GDM was determined to be 2.4 cm (area under the curve=0.90, sensitivity 75.61%, specificity 91.78%, P<0.001). The odds ratio was 2.91 (95% confidence interval, 1.07 to 7.92; P=0.034), which was higher than the 2.4 cm ASFT.

Conclusion

It was determined that ASFT as measured by US during the first trimester of pregnancy can be used to predict the risk of developing GDM during the second trimester of pregnancy and for prognosis.

Citations

Citations to this article as recorded by

Abdominal subcutaneous fat thickness combined with a 50-g glucose challenge test at 24-28 weeks of pregnancy in predicting gestational diabetes mellitus
Süleyman Cemil Oğlak, Emine Zeynep Yılmaz, Mehmet Şükrü Budak
Journal of Obstetrics and Gynaecology.2024;[Epub] CrossRef
Gestasyonel Diyabeti Olan ve Olmayan Gebelerin Sosyal Jetlag ve Beslenme Durumunun İncelenmesi
Deniz Çatar, Sinem Bayram
Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi Dergisi.2024; 19(2): 40. CrossRef
Magnesium from Deep Seawater as a Potentially Effective Natural Product against Insulin Resistance: A Randomized Trial
Ji Yeon Ham, You Kyung Jang, Byong Yeob Jeon, Yun Hee Shon
Medicina.2024; 60(8): 1265. CrossRef
The Value of Maternal Upper Abdominal Ad-ipose Thickness in Predicting GDM in Early Pregnancy
娜娜郭
Advances in Clinical Medicine.2023; 13(03): 4702. CrossRef
Evaluating the Adipose Tissue Depth as a Predictor Factor for Gestational Diabetes in Later Pregnancy—A Systematic Review
Bianca-Margareta Salmen, Valeria-Anca Pietrosel, Cristiana-Elena Durdu, Teodor Salmen, Cosmina Theodora Diaconu, Ioana-Cristina Bica, Claudia Gabriela Potcovaru, Florentina Gherghiceanu, Roxana-Adriana Stoica, Anca Pantea Stoian
Biomedicines.2023; 11(5): 1492. CrossRef
The Association Between Body Fat Index and Gestational Diabetes Mellitus: A Prospective Cohort Study
Sawanya Benchahong, Prasert Sunsaneevithayakul, Dittakarn Boriboonhirunsarn
Cureus.2023;[Epub] CrossRef
Ultrasound evaluation of subcutaneous and visceral abdominal fat as a predictor of gestational diabetes mellitus: a systematic review
Fernanda Teixeira Benevides, Edward Araujo Júnior, Carla Soraya Costa Maia, Renan Magalhães Montenegro Junior, Francisco Herlânio Costa Carvalho
The Journal of Maternal-Fetal & Neonatal Medicine.2022; 35(11): 2216. CrossRef
The Early Sonographic Prediction of Gestational Diabetes in Women From India
Shivani Gupta, Arjun Gupta, C. P. Swarnakar, Monika Rathore, Ramesh Beniwal, Kiran Meena, Anita Simlot, Nidhi Gupta
Journal of Diagnostic Medical Sonography.2022; 38(1): 18. CrossRef
Can maternal abdominal fat thickness predict antenatal insulin therapy in patients with gestational diabetes mellitus?
Sedat Akgöl, Mehmet Şükrü Budak, Süleyman Cemil Oğlak, Fatma Ölmez, Mehmet Emin Dilek, Serhat Kartal
Journal of Obstetrics and Gynaecology Research.2022; 48(3): 634. CrossRef
Prediction of gestational diabetes mellitus by different obesity indices
Zhimin Song, Yan Cheng, Tingting Li, Yongfang Fan, Qingying Zhang, Haidong Cheng
BMC Pregnancy and Childbirth.2022;[Epub] CrossRef
Association between maternal adiposity measures and adverse maternal outcomes of pregnancy: Systematic review and meta‐analysis
Nicola Heslehurst, Lem Ngongalah, Theophile Bigirumurame, Giang Nguyen, Adefisayo Odeniyi, Angela Flynn, Vikki Smith, Lisa Crowe, Becky Skidmore, Laura Gaudet, Alexandre Simon, Louise Hayes
Obesity Reviews.2022;[Epub] CrossRef
Association of body composition in early pregnancy with gestational diabetes mellitus: A meta-analysis
Fatemeh Alsadat Rahnemaei, Fatemeh Abdi, Reza Pakzad, Seyedeh Hajar Sharami, Fatemeh Mokhtari, Elham Kazemian, Rajakumar Anbazhagan
PLOS ONE.2022; 17(8): e0271068. CrossRef
Early Gestational Diabetes Detection Using Neural Network
Tanzina Rahman Hera, Md. Ashikur Rahman Khan, Nishu Nath
WSEAS TRANSACTIONS ON BIOLOGY AND BIOMEDICINE.2021; 18: 1. CrossRef
The association of general obesity, central obesity and visceral body fat with the risk of gestational diabetes mellitus: Evidence from a systematic review and meta-analysis
Sura M. Alwash, H. David McIntyre, Abdullah Mamun
Obesity Research & Clinical Practice.2021; 15(5): 425. CrossRef
Abdominal skin subcutaneous fat thickness over the gestational period in Korean pregnant women: a descriptive observational study
Moon Sook Hwang
Korean Journal of Women Health Nursing.2021; 27(4): 318. CrossRef
Relationship between Maternal Central Obesity and the Risk of Gestational Diabetes Mellitus: A Systematic Review and Meta-Analysis of Cohort Studies
Da Yao, Qing Chang, Qi-Jun Wu, Shan-Yan Gao, Huan Zhao, Ya-Shu Liu, Yu-Ting Jiang, Yu-Hong Zhao
Journal of Diabetes Research.2020; 2020: 1. CrossRef
Maternal Adipose Tissue Expansion, A Missing Link in the Prediction of Birth Weight Centile
Eleanor M Jarvie, Frances M Stewart, Jane E Ramsay, E Ann Brown, Barbara J Meyer, Gunilla Olivecrona, Bruce A Griffin, Dilys J Freeman
The Journal of Clinical Endocrinology & Metabolism.2020; 105(3): e814. CrossRef
Ultrasound assessment of maternal adipose tissue during 1st trimester screening for aneuploidies and risk of developing gestational diabetes
Francesco D’Ambrosi, Gabriele Rossi, Chiara M. Soldavini, Matteo Di Maso, Ilma F. Carbone, Giulia E. Cetera, Enrico Colosi, Enrico Ferrazzi
Acta Obstetricia et Gynecologica Scandinavica.2020; 99(5): 644. CrossRef
Vitamin D Deficiency at Mid-Pregnancy Is Associated with a Higher Risk of Postpartum Glucose Intolerance in Women with Gestational Diabetes Mellitus
Kyung-Soo Kim, Seok Won Park, Yong-Wook Cho, Soo-Kyung Kim
Endocrinology and Metabolism.2020; 35(1): 97. CrossRef
Fetal pancreatic hyperechogenicity may be an early ultrasonographic sign of gestational diabetes mellitus
Hatice Akkaya, Barış Büke, Gülsüm Uysal
The Journal of Maternal-Fetal & Neonatal Medicine.2020; 33(14): 2387. CrossRef
The Body Composition in Early Pregnancy is Associated with the Risk of Development of Gestational Diabetes Mellitus Late During the Second Trimester

Yanping Liu, Jing Liu, Yinjie Gao, Dan Zheng, Wei Pan, Min Nie, Liangkun Ma
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy.2020; Volume 13: 2367. CrossRef
New Diagnostic Criteria for Gestational Diabetes Mellitus and Pregnancy Outcomes in Korea
Kyu Yeon Hur
Diabetes & Metabolism Journal.2019; 43(6): 763. CrossRef
Inter and intra-reliability of ultrasonography for the measurement of abdominal subcutaneous & visceral adipose tissue thickness at 12 weeks gestation
Alexandra Cremona, Kevin Hayes, Clodagh S. O’Gorman, Ciara Ní Laighin, Khadijah I. Ismail, Alan E. Donnelly, Jill Hamilton, Amanda Cotter
BMC Medical Imaging.2019;[Epub] CrossRef
Maternal abdominal subcutaneous fat thickness as a simple predictor for gestational diabetes mellitus
Mehmet Sukru Budak, Ilker Kahramanoglu, Salvatore Giovanni Vitale, Sedat Akgol, Mehmet Emin Dilek, Serhat Kartal, Salvatore Caruso, Bekir Kahveci, Mehmet Obut, Muhammed Hanifi Bademkiran, Antonio Cianci
Journal of Perinatal Medicine.2019; 47(6): 605. CrossRef
Hypertriglyceridemia and Waist Phenotype as Markers in the Prediction of Gestational Diabetes in Iraqi Women
Faris Anwer Rasheed, Raghad Hasan Mshattat, Ulfat Mohammad Alnakkash, Saad Abdulrahma
Research Journal of Obstetrics and Gynecology.2018; 11(1): 25. CrossRef
The importance of treating mild hyperglycemia in pregnant women with diabetes
Kyung-Soo Kim
The Korean Journal of Internal Medicine.2018; 33(6): 1079. CrossRef
Anthropometric and ultrasound measures of maternal adiposity in the first trimester of pregnancy
Narelle Kennedy, Ann Quinton, Michael John Peek, Valeria Lanzarone, Ron Benzie, Ralph Nanan
Australasian Journal of Ultrasound in Medicine.2018; 21(3): 147. CrossRef
Simple Screening Using Ultrasonography for Prediction of Gestational Diabetes Mellitus
Seung Min Chung, Jun Sung Moon
Diabetes & Metabolism Journal.2017; 41(6): 438. CrossRef

Others
Generation of Insulin-Expressing Cells in Mouse Small Intestine by Pdx1, MafA, and BETA2/NeuroD: So-Hyun Lee, Marie Rhee, Ji-Won Kim, Kun-Ho Yoon; Diabetes Metab J. 2017;41(5):405-416. Published online September 5, 2017; DOI: https://doi.org/10.4093/dmj.2017.41.5.405

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Abstract PDF Supplementary Material PubReader

Background

To develop surrogate insulin-producing cells for diabetes therapy, adult stem cells have been identified in various tissues and studied for their conversion into β-cells. Pancreatic progenitor cells are derived from the endodermal epithelium and formed in a manner similar to gut progenitor cells. Here, we generated insulin-producing cells from the intestinal epithelial cells that induced many of the specific pancreatic transcription factors using adenoviral vectors carrying three genes: PMB (pancreatic and duodenal homeobox 1 [Pdx1], V-maf musculoaponeurotic fibrosarcoma oncogene homolog A [MafA], and BETA2/NeuroD).

Methods

By direct injection into the intestine through the cranial mesenteric artery, adenoviruses (Ad) were successfully delivered to the entire intestine. After virus injection, we could confirm that the small intestine of the mouse was appropriately infected with the Ad-Pdx1 and triple Ad-PMB.

Results

Four weeks after the injection, insulin mRNA was expressed in the small intestine, and the insulin gene expression was induced in Ad-Pdx1 and Ad-PMB compared to control Ad-green fluorescent protein. In addition, the conversion of intestinal cells into insulin-expressing cells was detected in parts of the crypts and villi located in the small intestine.

Conclusion

These data indicated that PMB facilitate the differentiation of mouse intestinal cells into insulin-expressing cells. In conclusion, the small intestine is an accessible and abundant source of surrogate insulin-producing cells.

Citations

Citations to this article as recorded by

Harnessing gut cells for functional insulin production: Strategies and challenges
Kelvin Baafi, John C. March
Biotechnology Notes.2023; 4: 7. CrossRef
Differential Morphological Diagnosis of Various Forms of Congenital Hyperinsulinism in Children
Lubov Borisovna Mitrofanova, Anastasia Arkadyevna Perminova, Daria Viktorovna Ryzhkova, Anna Andreyevna Sukhotskaya, Vladimir Gireyevich Bairov, Irina Leorovna Nikitina
Frontiers in Endocrinology.2021;[Epub] CrossRef
Generation of iPSC-derived insulin-producing cells from patients with type 1 and type 2 diabetes compared with healthy control
Min Jung Kim, Eun Young Lee, Young-Hye You, Hae Kyung Yang, Kun-Ho Yoon, Ji-Won Kim
Stem Cell Research.2020; 48: 101958. CrossRef
ERK Regulates NeuroD1-mediated Neurite Outgrowth via Proteasomal Degradation
Tae-young Lee, In-Su Cho, Narayan Bashyal, Francisco J Naya, Ming-Jer Tsai, Jeong Seon Yoon, Jung-Mi Choi, Chang-Hwan Park, Sung-Soo Kim, Haeyoung Suh-Kim
Experimental Neurobiology.2020; 29(3): 189. CrossRef
Generation of a PDX1–EGFP reporter human induced pluripotent stem cell line, KSCBi005-A-3, using the CRISPR/Cas9 system
Youngsun Lee, Hye Young Choi, Ara Kwon, Hyeyeon Park, Mi-Hyun Park, Ji-Won Kim, Min Jung Kim, Yong-Ou Kim, Sungwook Kwak, Soo Kyung Koo
Stem Cell Research.2019; 41: 101632. CrossRef

Clinical Diabetes & Therapeutics
Determinants of Long-Term Durable Glycemic Control in New-Onset Type 2 Diabetes Mellitus: Kyoung Jin Kim, Ju Hee Choi, Kyeong Jin Kim, Jee Hyun An, Hee Young Kim, Sin Gon Kim, Nam Hoon Kim; Diabetes Metab J. 2017;41(4):284-295. Published online August 3, 2017; DOI: https://doi.org/10.4093/dmj.2017.41.4.284

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Abstract PDF Supplementary Material PubReader

Background

Long-term durable glycemic control is a difficult goal in the management of type 2 diabetes mellitus (T2DM). We evaluated the factors associated with durable glycemic control in a real clinical setting.

Methods

We retrospectively reviewed the medical records of 194 new-onset, drug-naïve patients with T2DM who were diagnosed between January 2011 and March 2013, and were followed up for >2 years. Glycemic durability was defined as the maintenance of optimal glycemic control (glycosylated hemoglobin [HbA1c] <7.0%) for 2 years without substitution or adding other glucose-lowering agents. Clinical factors and glycemic markers associated with glycemic durability were compared between two groups: a durability group and a non-durability group.

Results

Patients in the durability group had a higher baseline body mass index (26.1 kg/m² vs. 24.9 kg/m²) and lower HbA1c (8.6% vs. 9.7%) than the non-durability group. The initial choice of glucose-lowering agents was similar in both groups, except for insulin and sulfonylureas, which were more frequently prescribed in the non-durability group. In multiple logistic regression analyses, higher levels of education, physical activity, and homeostasis model assessment of β-cell function (HOMA-β) were associated with glycemic durability. Notably, lower HbA1c (<7.0%) at baseline and first follow-up were significantly associated with glycemic durability (adjusted odds ratio [OR], 7.48; 95% confidence interval [CI], 2.51 to 22.3) (adjusted OR, 9.27; 95% CI, 1.62 to 53.1, respectively), after adjusting for confounding variables including the types of glucose-lowering agents.

Conclusion

Early achievement of HbA1c level within the glycemic target was a determinant of long-term glycemic durability in new-onset T2DM, as were higher levels of education, physical activity, and HOMA-β.

Citations

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Initial Combination Therapy in Type 2 Diabetes
Ji Yoon Kim, Nam Hoon Kim
Endocrinology and Metabolism.2024; 39(1): 23. CrossRef
Validation of RSSDI therapeutic wheel with clinical experience of Indian physicians
Dhruvi Hasnani, Vipul Chavda, Dinesh Agrawal, Bijay Patni, Ashwin David, Sachin Gathe, Rajeev Chawla, Jothydev Kesavadev, Sunil Gupta, Shriji Hasnani, Banshi Saboo
International Journal of Diabetes in Developing Countries.2022; 42(3): 451. CrossRef
Greater Glycemic Burden Is Associated with Further Poorer Glycemic Control in Newly-Diagnosed Type 2 Diabetes Mellitus Patients
Wei-Lun Wen, Hui-Chun Huang, Hsiu-Chu Lin, Wan-Ching Lo, Szu-Chia Chen, Mei-Yueh Lee
Nutrients.2022; 14(2): 320. CrossRef
Durability of glucose-lowering effect of dulaglutide in patients with type 2 diabetes mellitus: A real-world data study
Hwi Seung Kim, Yun Kyung Cho, Myung Jin Kim, Chang Hee Jung, Joong-Yeol Park, Woo Je Lee
Frontiers in Endocrinology.2022;[Epub] CrossRef
Durability of glycaemic control in type 2 diabetes: A systematic review and meta‐analysis for its association with body weight changes
Danpei Li, HuaJie Zou, Ping Yin, Wenjun Li, Junyu He, Shuyun Wang, Li Huang, Shiying Shao, Yong Chen, Yan Yang, Xuefeng Yu
Diabetes, Obesity and Metabolism.2021; 23(1): 208. CrossRef
Early combination versus initial metformin monotherapy in the management of newly diagnosed type 2 diabetes: AnEast Asianperspective
Linong Ji, Juliana C. N. Chan, Miao Yu, Kun Ho Yoon, Sin Gon Kim, Sung Hee Choi, Chien‐Ning Huang, Shih Te Tu, Chih‐Yuan Wang, Päivi Maria Paldánius, Wayne H. H. Sheu
Diabetes, Obesity and Metabolism.2021; 23(1): 3. 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
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(3): 368. CrossRef
Effectiveness of Resistance Training and Associated Program Characteristics in Patients at Risk for Type 2 Diabetes: a Systematic Review and Meta-analysis
Raza Qadir, Nicholas F. Sculthorpe, Taylor Todd, Elise C. Brown
Sports Medicine - Open.2021;[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)
Ja Young Jeon
Diabetes & Metabolism Journal.2021; 45(4): 613. CrossRef
Association of Habitual Daily Physical Activity With Glucose Tolerance and β-Cell Function in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes From the Restoring Insulin Secretion (RISE) Study
Karla A. Temple, Ashley H. Tjaden, Karen M. Atkinson, Elena Barengolts, Tamara S. Hannon, Kieren J. Mather, Kristina M. Utzschneider, Sharon L. Edelstein, David A. Ehrmann, Babak Mokhlesi, Philip S. Zeitler, Jayne Williams, Melanie Cree-Green, Yesenia Gar
Diabetes Care.2019; 42(8): 1521. CrossRef
Factors Associated with Poor Hemoglobin A1c Control in Patients with Type 2 Diabetes
Salam Alqudah, Anan S. Jarab, Eman A. Alefishat, Fadia Mayyas, Maher Khdour, Sharrel Pinto
Current Diabetes Reviews.2019; 15(2): 164. 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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Abstract PDF PubReader

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.

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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
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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
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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

Others
Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial: Kyung-Wan Min, Bon Jeong Ku, Ji-Hyun Lee, Min-Seon Kim, Kyu-Jeung Ahn, Moon-Kyu Lee, Satoshi Kokubo, Satoshi Yoshida, Hyun-Ji Cho, Bong-Soo Cha; Diabetes Metab J. 2017;41(2):135-145. Published online January 11, 2017; DOI: https://doi.org/10.4093/dmj.2017.41.2.135

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Background

This is a subgroup analysis of Korean patients from a phase 3 clinical trial investigating the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin.

Methods

This multicenter, placebo-controlled, double-blind, parallel-group study was carried out between November 2011 and January 2013. Patients entered a 2-week placebo pretreatment period, followed by a 24-week treatment period with either ipragliflozin (50 mg/day) or placebo, while continuing metformin. Efficacy outcomes (glycosylated hemoglobin [HbA1c], fasting plasma glucose [FPG], and body weight) and safety outcomes (treatment-emergent adverse events [TEAEs]) were measured and compared between the two treatment groups for patients enrolled in all 18 study sites in Korea.

Results

Eighty-two Korean patients received ipragliflozin (n=43) or placebo (n=39) during the study period. Mean changes in HbA1c levels from baseline to the end of treatment were –0.97% in the ipragliflozin group and –0.31% in the placebo group, with an adjusted between-group difference of –0.60% (P<0.001). Compared to placebo, FPG and body weight also decreased significantly (both P<0.001) from baseline after treatment in the ipragliflozin group, with between-group differences of –21.4 mg/dL and –1.53 kg, respectively. Decreased weight was the most common TEAE in the ipragliflozin group (7.0%); there were no reports of genital and urinary tract infection.

Conclusion

Ipragliflozin treatment in addition to metformin led to significant improvement in glycemic outcomes and reduction in body weight in Korean patients with type 2 diabetes mellitus, compared with metformin treatment alone; the safety profile was comparable in both groups.

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International Journal of Diabetes in Developing Countries.2022; 42(1): 147. CrossRef
SGLT2 Inhibitors as Add-On Therapy to Metformin for People with Type 2 Diabetes: A Review of Placebo-Controlled Trials in Asian versus Non-Asian Patients

André J Scheen
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy.2020; Volume 13: 2765. CrossRef
Ipragliflozin Additively Ameliorates Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes Controlled with Metformin and Pioglitazone: A 24-Week Randomized Controlled Trial
Eugene Han, Yong-ho Lee, Byung-Wan Lee, Eun Seok Kang, Bong-Soo Cha
Journal of Clinical Medicine.2020; 9(1): 259. CrossRef
Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials
Atsunori Kashiwagi, Marina V. Shestakova, Yuichiro Ito, Masahiro Noguchi, Wim Wilpshaar, Satoshi Yoshida, John P. H. Wilding
Diabetes Therapy.2019; 10(6): 2201. CrossRef
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Habib Yaribeygi, Stephen L. Atkin, Amirhossein Sahebkar
Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2019; 13(2): 1679. CrossRef
Ipragliflozin as an add-on therapy in type 2 diabetes mellitus patients: An evidence-based pharmacoeconomics evaluation
Hongmei Wang, Gaoqiong Yao, Xi Chen, Jing Ouyang, Jiadan Yang
Diabetes Research and Clinical Practice.2019; 157: 107867. CrossRef
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Eugene Han, Ari Kim, Sung Jae Lee, Je-Yon Kim, Jae Hyeon Kim, Woo Je Lee, Byung-Wan Lee
Diabetes Therapy.2018; 9(4): 1689. CrossRef
A phase 3 randomized placebo-controlled trial to assess the efficacy and safety of ipragliflozin as an add-on therapy to metformin in Russian patients with inadequately controlled type 2 diabetes mellitus
Marina V. Shestakova, John P.H. Wilding, Wim Wilpshaar, Reiner Tretter, Valeria L. Orlova, Andrey F. Verbovoy
Diabetes Research and Clinical Practice.2018; 146: 240. CrossRef
Efficacy and safety of ipragliflozin as an add‐on therapy to sitagliptin and metformin in Korean patients with inadequately controlled type 2 diabetes mellitus: A randomized controlled trial
Kyung‐Ah Han, Suk Chon, Choon Hee Chung, Soo Lim, Kwan‐Woo Lee, SeiHyun Baik, Chang Hee Jung, Dong‐Sun Kim, Kyong Soo Park, Kun‐Ho Yoon, In‐Kyu Lee, Bong‐Soo Cha, Taishi Sakatani, Sumi Park, Moon‐Kyu Lee
Diabetes, Obesity and Metabolism.2018; 20(10): 2408. CrossRef
Antihyperglycemic Agent Therapy for Adult Patients with Type 2 Diabetes Mellitus 2017: A Position Statement of the Korean Diabetes Association
Seung-Hyun Ko, Kyu-Yeon Hur, Sang Youl Rhee, Nan-Hee Kim, Min Kyong Moon, Seok-O Park, Byung-Wan Lee, Hyun Jin Kim, Kyung Mook Choi, Jin Hwa Kim
Diabetes & Metabolism Journal.2017; 41(5): 337. CrossRef
Antihyperglycemic agent therapy for adult patients with type 2 diabetes mellitus 2017: a position statement of the Korean Diabetes Association
Seung-Hyun Ko, Kyu-Yeon Hur, Sang Youl Rhee, Nan-Hee Kim, Min Kyong Moon, Seok-O Park, Byung-Wan Lee, Hyun Jin Kim, Kyung Mook Choi, Jin Hwa Kim
The Korean Journal of Internal Medicine.2017; 32(6): 947. CrossRef
Combination therapy of oral hypoglycemic agents in patients with type 2 diabetes mellitus
Min Kyong Moon, Kyu Yeon Hur, Seung-Hyun Ko, Seok-O Park, Byung-Wan Lee, Jin Hwa Kim, Sang Youl Rhee, Hyun Jin Kim, Kyung Mook Choi, Nan-Hee Kim
The Korean Journal of Internal Medicine.2017; 32(6): 974. CrossRef
Combination Therapy of Oral Hypoglycemic Agents in Patients with Type 2 Diabetes Mellitus
Min Kyong Moon, Kyu-Yeon Hur, Seung-Hyun Ko, Seok-O Park, Byung-Wan Lee, Jin Hwa Kim, Sang Youl Rhee, Hyun Jin Kim, Kyung Mook Choi, Nan-Hee Kim
Diabetes & Metabolism Journal.2017; 41(5): 357. CrossRef

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