- Drug/Regimen
- Effect of Dapagliflozin as an Add-on Therapy to Insulin on the Glycemic Variability in Subjects with Type 2 Diabetes Mellitus (DIVE): A Multicenter, Placebo-Controlled, Double-Blind, Randomized Study
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Seung-Hwan Lee, Kyung-Wan Min, Byung-Wan Lee, In-Kyung Jeong, Soon-Jib Yoo, Hyuk-Sang Kwon, Yoon-Hee Choi, Kun-Ho Yoon
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Diabetes Metab J. 2021;45(3):339-348. Published online May 28, 2020
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DOI: https://doi.org/10.4093/dmj.2019.0203
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10,049
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Background
Glycemic variability is associated with the development of diabetic complications and hypoglycemia. However, the effect of sodium-glucose transporter 2 (SGLT2) inhibitors on glycemic variability is controversial. We aimed to examine the effect of dapagliflozin as an add-on therapy to insulin on the glycemic variability assessed using continuous glucose monitoring (CGM) in subjects with type 2 diabetes mellitus.
Methods
In this multicenter, placebo-controlled, double-blind, randomized study, 84 subjects received 10 mg of dapagliflozin (n=41) or the placebo (n=43) for 12 weeks. CGM was performed before and after treatment to compare the changes in glycemic variability measures (standard deviation [SD], mean amplitude of glycemic excursions [MAGEs]).
Results
At week 12, significant reductions in glycosylated hemoglobin (−0.74%±0.66% vs. 0.01%±0.65%, P<0.001), glycated albumin (−3.94%±2.55% vs. −0.67%±2.48%, P<0.001), and CGM-derived mean glucose (−41.6±39.2 mg/dL vs. 1.1±46.2 mg/dL, P<0.001) levels were observed in the dapagliflozin group compared with the placebo group. SD and MAGE were significantly decreased in the dapagliflozin group, but not in the placebo group. However, the difference in ΔSD and ΔMAGE failed to reach statistical significance between two groups. No significant differences in the incidence of safety endpoints were observed between the two groups.
Conclusion
Dapagliflozin effectively decreased glucose levels, but not glucose variability, after 12 weeks of treatment in participants with type 2 diabetes mellitus receiving insulin treatment. The role of SGLT2 inhibitors in glycemic variability warrants further investigations.
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Citations
Citations to this article as recorded by  - Selective sodium-glucose cotransporter-2 inhibitors in the improvement of hemoglobin and hematocrit in patients with type 2 diabetes mellitus: a network meta-analysis
Yuanyuan Luo, Ruojing Bai, Wei Zhang, Guijun Qin
Frontiers in Endocrinology.2024;[Epub] CrossRef - Continuous Glucose Monitoring Profiles and Health Outcomes After Dapagliflozin Plus Saxagliptin vs Insulin Glargine
Donald C Simonson, Marcia A Testa, Ella Ekholm, Maxwell Su, Tina Vilsbøll, Serge A Jabbour, Marcus Lind
The Journal of Clinical Endocrinology & Metabolism.2024; 109(12): e2261. CrossRef - Impact of empagliflozin on insulin needs in patients with heart failure and diabetes: An EMPEROR‐Pooled analysis
Khawaja M. Talha, Jennifer Green, Gerasimos Filippatos, Stuart Pocock, Faiez Zannad, Martina Brueckmann, Elke Schueler, Anne Pernille Ofstad, João Pedro Ferreira, Stefan D. Anker, Javed Butler, Julio Rosenstock, Milton Packer
Diabetes, Obesity and Metabolism.2024; 26(7): 2578. CrossRef - Dapagliflozin in heart failure and type 2 diabetes: Efficacy, cardiac and renal effects, safety
Pei-Ling Yu, You Yu, Shuang Li, Bai-Chen Mu, Ming-Hua Nan, Min Pang
World Journal of Diabetes.2024; 15(7): 1518. CrossRef - Glycemic Variability in Pancreatogenic Diabetes Mellitus: characteristics, Risks, Potential Mechanisms, and Treatment Possibilities
Yuyan Sun, Bing Lu, Yuanwen Hu, Yingqi Lv, Shao Zhong
International Journal of General Medicine.2024; Volume 17: 4297. CrossRef - Risk of Urinary Tract Infection in Patients with Type 2 Diabetes Mellitus Treated with Dapagliflozin: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Zhigui Zheng, Dongyuan He, Jianguo Chen, Xiaohui Xie, Yunan Lu, Binbin Wu, Xinxin Jiang
Clinical Drug Investigation.2023; 43(4): 209. CrossRef - Effect of SGLT2 Inhibitors and Metformin on Inflammatory and Prognostic
Biomarkers in Type 2 Diabetes Patients
Yang Cao, Ning Liang, Ting Liu, Jingai Fang, Xiaodong Zhang
Endocrine, Metabolic & Immune Disorders - Drug Targets.2023; 23(4): 530. CrossRef - What is Glycaemic Variability and which Pharmacological Treatment Options are Effective? A Narrative Review
Juan Miguel Huertas Cañas, Maria Alejandra Gomez Gutierrez, Andres Bedoya Ossa
European Endocrinology.2023; 19(2): 4. CrossRef - La variabilité glycémique : un facteur de risque singulier à conjuguer au pluriel
Louis Monnier, Claude Colette, Fabrice Bonnet, David Owens
Médecine des Maladies Métaboliques.2022; 16(1): 15. CrossRef - Association between Variability of Metabolic Risk Factors and Cardiometabolic Outcomes
Min Jeong Park, Kyung Mook Choi
Diabetes & Metabolism Journal.2022; 46(1): 49. CrossRef - Effect of sodium-glucose cotransporter-2 (SGLT2) inhibitors on serum urate levels in patients with and without diabetes: a systematic review and meta-regression of 43 randomized controlled trials
Alicia Swee Yan Yip, Shariel Leong, Yao Hao Teo, Yao Neng Teo, Nicholas L. X. Syn, Ray Meng See, Caitlin Fern Wee, Elliot Yeung Chong, Chi-Hang Lee, Mark Y. Chan, Tiong-Cheng Yeo, Raymond C. C. Wong, Ping Chai, Ching-Hui Sia
Therapeutic Advances in Chronic Disease.2022;[Epub] CrossRef - Hypoglycemic agents and glycemic variability in individuals with type 2 diabetes: A systematic review and network meta-analysis
SuA Oh, Sujata Purja, Hocheol Shin, Minji Kim, Eunyoung Kim
Diabetes and Vascular Disease Research.2022;[Epub] CrossRef - The Clinical Effect of Dapagliflozin in Patients with Angiographically Confirmed Coronary Artery Disease and Concomitant Type 2 Diabetes Mellitus
Yana Yu. Dzhun, Yevhen Yu. Marushko, Yanina A. Saienko, Nadiya M. Rudenko, Borys M. Mankovsky
Ukrainian Journal of Cardiovascular Surgery.2022; 30(3): 35. CrossRef - Stress-Induced Hyperglycaemia in Non-Diabetic Patients with Acute Coronary Syndrome: From Molecular Mechanisms to New Therapeutic Perspectives
Alessandro Bellis, Ciro Mauro, Emanuele Barbato, Antonio Ceriello, Antonio Cittadini, Carmine Morisco
International Journal of Molecular Sciences.2021; 22(2): 775. CrossRef - Glycemic Variability Impacted by SGLT2 Inhibitors and GLP 1 Agonists in Patients with Diabetes Mellitus: A Systematic Review and Meta-Analysis
Heeyoung Lee, Se-eun Park, Eun-Young Kim
Journal of Clinical Medicine.2021; 10(18): 4078. CrossRef - Effect of Dapagliflozin on Glycemic Variability in Patients with Type 2 Diabetes under Insulin Glargine Combined with Other Oral Hypoglycemic Drugs
Menghui Luo, Xiaocen Kong, Huiying Wang, Xiaofang Zhai, Tingting Cai, Bo Ding, Yun Hu, Ting Jing, Xiaofei Su, Huiqin Li, Jianhua Ma, Yoshifumi Saisho
Journal of Diabetes Research.2020; 2020: 1. CrossRef - Time in Range from Continuous Glucose Monitoring: A Novel Metric for Glycemic Control
Jee Hee Yoo, Jae Hyeon Kim
Diabetes & Metabolism Journal.2020; 44(6): 828. CrossRef
- Others
- Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial
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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
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Diabetes Metab J. 2017;41(2):135-145. Published online January 11, 2017
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DOI: https://doi.org/10.4093/dmj.2017.41.2.135
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6,483
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Abstract
PDFPubReader
- 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. MethodsThis 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. ResultsEighty-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. ConclusionIpragliflozin 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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Citations
Citations to this article as recorded by
- The Effects of Small Sized Rice Bowl on Carbohydrate Intake and Dietary Patterns in Women with Type 2 Diabetes
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Hee-Jung Ahn, Yu-Kyung Eom, Kyung-Ah Han, Hwi-Ryun Kwon, Hyun Jin Kim, Kang Seo Park, Kyung-Wan Min
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Korean Diabetes J. 2010;34(3):166-173. Published online June 30, 2010
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DOI: https://doi.org/10.4093/kdj.2010.34.3.166
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4,299
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36
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4
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Abstract
PDFPubReader
- Background
The main source of carbohydrate in the Korean diet is rice, which is usually served in a rice bowl. This study investigated the impact of a meal plan using smaller rice bowls on dietary energy intake and macronutrient composition in overweight or obese patients with type 2 diabetes mellitus. MethodsA total of 67 women with type 2 diabetes were enrolled in our study. We divided these participants into three groups: a normal-weight group (NW; body mass index [BMI] < 23 kg/m2; n = 17), an overweight group (OW; 23 ≤ BMI < 25 kg/m2; n = 24) and an obese group (OB; BMI ≥ 25 kg/m2; n = 26). Three-day dietary records were analyzed for total energy intake (TEI) and macronutrient composition both before enrollment and two weeks after patients received instruction in a dietary plan based on using a small (200 mL) rice bowl. ResultsAfter the intervention, TEI decreased in the OW and OB groups. Decreased carbohydrate (NW, -4 ± 5%; OW, -4 ± 5%; OB, -3 ± 6%) and increased fat intakes were found in all three groups, which complies with Korean Diabetes Association recommendations. The protein proportion of TEI significantly increased only in the OW group. Body weight decreased both in the OW and OB groups. ConclusionA short-term, small-rice-bowl-based meal plan was effective for body weight control and macronutrient balance in overweight or obese women in Korea with type 2 diabetes.
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Citations
Citations to this article as recorded by - Diet Therapy Using a Small Rice Bowl among Japanese Men with Diabetes: A Randomized Controlled Trial
Misa Shimpo, Shiori Toga-Sato, Takahiro Tosaki
Journal of Obesity & Metabolic Syndrome.2022; 31(4): 345. CrossRef - A traditional Asian diet modified to meet nutritional requirements of diabetes, has anything changed? A cross-sectional dietary survey
Arjuna Medagama, Heshan Widanapathirana
BMC Nutrition.2015;[Epub] CrossRef - Relationship between Milk and Calcium Intake and Lipid Metabolism in Female Patients with Type 2 Diabetes
JaeHee Kim, Ji-Yun Hwang, Ki Nam Kim, Young-Ju Choi, Namsoo Chang, Kap-Bum Huh
Yonsei Medical Journal.2013; 54(3): 626. CrossRef - The Small Rice Bowl-Based Meal Plan was Effective at Reducing Dietary Energy Intake, Body Weight, and Blood Glucose Levels in Korean Women with Type 2 Diabetes Mellitus
Hee Jung Ahn, Kyung Ah Han, Hwi Ryun Kwon, Kyung Wan Min
Korean Diabetes Journal.2010; 34(6): 340. CrossRef
- Small Rice Bowl-Based Meal Plan versus Food Exchange-Based Meal Plan for Weight, Glucose and Lipid Control in Obese Type 2 Diabetic Patients
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Hee-Jung Ahn, Kyung-Ah Han, Hwi-Ryun Kwon, Bo-Kyung Koo, Hyun-Jin Kim, Kang-Seo Park, Kyung-Wan Min
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Korean Diabetes J. 2010;34(2):86-94. Published online April 30, 2010
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DOI: https://doi.org/10.4093/kdj.2010.34.2.86
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4,496
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39
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10
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Abstract
PDFPubReader
- Background
The Korean National Health and Nutrition Examination Surveys reported 65% of daily energy intake (EI) as carbohydrate (CHO) in the Korean population and main source of CHO was cooked rice. We used a standardized-small sized rice bowl for diet education and investigated its effectiveness on body weight, glucose and lipid, compared to the conventional food exchange system in type 2 diabetes obese women. MethodsType 2 diabetic women with body mass index ≥ 23 kg/m2 were randomly assigned to small rice bowl-based meal plan (BM) and food exchange-based meal plan (ExM) group. Both groups were asked to reduce their EI by 500 kcal/day for 12 weeks. The macronutrient composition was instructed: 55 to 60% of EI as CHO, 15 to 20% as protein, and 20 to 25% as fat. BM group received only a simple instruction for application of the rice bowl. Nutrient intake was estimated with the 3-day dietary records. ResultsFinally, 44 subjects finished the study. The percent reduction of body weight was significant both BM group (-5.1 ± 2.6%) and ExM group (-4.8 ± 2.8%) after 12 weeks (P < 0.001) but there was no difference between the groups. There was no difference in the proportional change of CHO, protein and fat in EI between the groups. Additionally, the change of HbA1c and low density lipoprotein-cholesterol were not significantly different between the two groups. ConclusionThe BM group was as effective as ExM for body weight and glucose control in type 2 diabetes obese women.
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Citations
Citations to this article as recorded by - Development of a Sport Food Exchange List for Dietetic Practice in Sport Nutrition
José Miguel Martínez-Sanz, Susana Menal-Puey, Isabel Sospedra, Giuseppe Russolillo, Aurora Norte, Iva Marques-Lopes
Nutrients.2020; 12(8): 2403. CrossRef - The Effect of Combined Therapy with Fenugreek and Nutrition Training Based on Iranian Traditional Medicine on FBS, HgA1c, BMI, and Waist Circumference in Type 2 Diabetic Patients: a Randomized Double Blinded Clinical Trial
Seyyedeh Seddigheh Hassani, Arezodar Fallahi, Seyyed Saeid Esmaeili, Mohammad Gholami Fesharaki
Journal of Advances in Medical and Biomedical Research.2019; 27(120): 37. CrossRef - Development of a Spanish Food Exchange List: Application of Statistical Criteria to a Rationale Procedure
Iva Marques-Lopes, Susana Menal-Puey, J. Alfredo Martínez, Giuseppe Russolillo
Journal of the Academy of Nutrition and Dietetics.2018; 118(7): 1161. CrossRef - A Practical Approach to the Management of Micronutrients and Other Nutrients of Concern in Food Exchange Lists for Meal Planning
Giuseppe Russolillo-Femenías, Susana Menal-Puey, J. Alfredo Martínez, Iva Marques-Lopes
Journal of the Academy of Nutrition and Dietetics.2018; 118(11): 2029. CrossRef - Anemia is inversely associated with serum C-peptide concentrations in individuals with type 2 diabetes
Jin Ook Chung, Seon-Young Park, Dong Hyeok Cho, Dong Jin Chung, Min Young Chung
Medicine.2018; 97(32): e11783. CrossRef - Relationship between serum C-peptide level and diabetic retinopathy according to estimated glomerular filtration rate in patients with type 2 diabetes
Jin Ook Chung, Dong Hyeok Cho, Dong Jin Chung, Min Young Chung
Journal of Diabetes and its Complications.2015; 29(3): 350. CrossRef - Serum bilirubin concentrations are positively associated with serum C‐peptide levels in patients with Type 2 diabetes
J. O. Chung, D. H. Cho, D. J. Chung, M. Y. Chung
Diabetic Medicine.2014; 31(11): 1316. CrossRef - Association between serum C-peptide levels and chronic microvascular complications in Korean type 2 diabetic patients
Bo-Yeon Kim, Chan-Hee Jung, Ji-Oh Mok, Sung-Koo Kang, Chul-Hee Kim
Acta Diabetologica.2012; 49(1): 9. CrossRef - Small Rice Bowl-Based Meal Plan for Energy and Marcronutrient Intake in Korean Men with Type 2 Diabetes: A Pilot Study
Hee Jung Ahn, Kyung Ah Han, Jin Young Jang, Jae Hyuk Lee, Kang Seo Park, Kyung Wan Min
Diabetes & Metabolism Journal.2011; 35(3): 273. CrossRef - The Small Rice Bowl-Based Meal Plan was Effective at Reducing Dietary Energy Intake, Body Weight, and Blood Glucose Levels in Korean Women with Type 2 Diabetes Mellitus
Hee Jung Ahn, Kyung Ah Han, Hwi Ryun Kwon, Kyung Wan Min
Korean Diabetes Journal.2010; 34(6): 340. CrossRef
- Response: The Effects of Low-Calorie Diets on Abdominal Visceral Fat, Muscle Mass, and Dietary Quality in Obese Type 2 Diabetic Subjects (Korean Diabetes J 2009;33:526-36)
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Hee-Jung Ahn, Kyung-Wan Min
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Korean Diabetes J. 2010;34(1):68-69. Published online February 28, 2010
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DOI: https://doi.org/10.4093/kdj.2010.34.1.68
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3,089
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Citations to this article as recorded by - Association of a High Healthy Eating Index Diet with Long-Term Visceral Fat Loss in a Large Longitudinal Study
Sunmin Park
Nutrients.2024; 16(4): 534. CrossRef
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