Ehsan Aliniagerdroudbari, Zahra Farhangian, S. Babaniamansour, M. Niroomand
Objective: This study aimed to assess the association between glycemic control status and serum levels of vitamin D3 in Iranian patients with type 2 diabetes (T2D). Materials and methods: This was a cross-sectional study on 452 patients with T2D in Tehran, Iran, performed between September 2019 and September 2020. We assessed the diabetes laboratory test and vitamin D3 level in all participants using the Enzymatic Glucose Oxidase method. Data were analyzed using SPSS version 24. Results: a total of 452 patients were enrolled in this study (mean age: 59.4 ± 11.4 years, 63.5% females). Vitamin D deficiency was reported in half of the partici -pants. Deficient vitamin D was significantly associated with higher mean level of hemoglobin A1c, fasting plasma glucose, total cholesterol, and low-density lipoprotein-cholesterol (p < 0.05). Multiple regression showed that the level of vitamin D3 could be a good predictor of hemoglobin A1c after adjusting for confounding variables affecting the hemoglobin A1c (regression coefficient: 0.442, 95% CI, 0.072–0.811, p = 0.063). Conclusions: With the alarming rates of vitamin D deficiency in patients with T2D, there was a significant direct association between vitamin D3 and hemoglobin A1c levels before and after adjusting for the associated factors. (Clin Diabetol 2022, 11; 4: 262–268)
目的:本研究旨在评估伊朗2型糖尿病(T2D)患者血糖控制状况与血清维生素D3水平之间的关系。材料和方法:这是一项对2019年9月至2020年9月在伊朗德黑兰进行的452例T2D患者的横断面研究。我们使用酶促葡萄糖氧化酶法评估所有参与者的糖尿病实验室测试和维生素D3水平。数据采用SPSS version 24进行分析。结果:共纳入452例患者(平均年龄59.4±11.4岁，女性占63.5%)。一半的参与者报告缺乏维生素D。缺乏维生素D与血红蛋白A1c、空腹血糖、总胆固醇和低密度脂蛋白-胆固醇的平均水平升高显著相关(p < 0.05)。多元回归显示，在调整影响血红蛋白A1c的混杂变量后，维生素D3水平可以很好地预测血红蛋白A1c(回归系数:0.442,95% CI, 0.072-0.811, p = 0.063)。结论:在T2D患者维生素D缺乏率惊人的情况下，调整相关因素前后，维生素D3与血红蛋白A1c水平存在显著的直接关联。(临床糖尿病杂志，2022,11;4: 262 - 268)
{"title":"Association Between Glycemic Control Status and Serum Level of Vitamin D3 in Patients with Type 2 Diabetes: A Cross-Sectional Study","authors":"Ehsan Aliniagerdroudbari, Zahra Farhangian, S. Babaniamansour, M. Niroomand","doi":"10.5603/dk.a2022.0032","DOIUrl":"https://doi.org/10.5603/dk.a2022.0032","url":null,"abstract":"Objective: This study aimed to assess the association between glycemic control status and serum levels of vitamin D3 in Iranian patients with type 2 diabetes (T2D). Materials and methods: This was a cross-sectional study on 452 patients with T2D in Tehran, Iran, performed between September 2019 and September 2020. We assessed the diabetes laboratory test and vitamin D3 level in all participants using the Enzymatic Glucose Oxidase method. Data were analyzed using SPSS version 24. Results: a total of 452 patients were enrolled in this study (mean age: 59.4 ± 11.4 years, 63.5% females). Vitamin D deficiency was reported in half of the partici -pants. Deficient vitamin D was significantly associated with higher mean level of hemoglobin A1c, fasting plasma glucose, total cholesterol, and low-density lipoprotein-cholesterol (p < 0.05). Multiple regression showed that the level of vitamin D3 could be a good predictor of hemoglobin A1c after adjusting for confounding variables affecting the hemoglobin A1c (regression coefficient: 0.442, 95% CI, 0.072–0.811, p = 0.063). Conclusions: With the alarming rates of vitamin D deficiency in patients with T2D, there was a significant direct association between vitamin D3 and hemoglobin A1c levels before and after adjusting for the associated factors. (Clin Diabetol 2022, 11; 4: 262–268)","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90426964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Ordooei, Marzie Vaghefi, Zahra Nafei, Shakiba Abbaszade
Address for correspondence: Zahra Nafei Children Growth Disorder Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran email: nafeiy@yahoo.com Clinical Diabetology 2022, 11; 4: 294–295 DOI: 10.5603/DK.a2022.0036 Received: 31.05.2022 Accepted: 24.06.2022 Mahtab Ordooei1, Marzie Vaghefi1, Zahra Nafei1, Shakiba Abbaszade2 1Children Growth Disorder Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran 2Department of Pediatrics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
{"title":"First Clinical Manifestations of Type 1 Diabetes Mellitus Among Hospitalized Children in Yazd, Iran: A Single-Center Experience","authors":"M. Ordooei, Marzie Vaghefi, Zahra Nafei, Shakiba Abbaszade","doi":"10.5603/dk.a2022.0036","DOIUrl":"https://doi.org/10.5603/dk.a2022.0036","url":null,"abstract":"Address for correspondence: Zahra Nafei Children Growth Disorder Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran email: nafeiy@yahoo.com Clinical Diabetology 2022, 11; 4: 294–295 DOI: 10.5603/DK.a2022.0036 Received: 31.05.2022 Accepted: 24.06.2022 Mahtab Ordooei1, Marzie Vaghefi1, Zahra Nafei1, Shakiba Abbaszade2 1Children Growth Disorder Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran 2Department of Pediatrics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83721002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
G. Bahrami, R. Naseri, M. Khosravifar, Soraya Sajadimajd, Bahareh Mohammadi, F. Heydarpour, Sanaz Cheraghialiakbari
Objective: Non-alcoholic fatty liver (NAFL) is a common pathology of hepatocytes due to the accumulation of fat which is predominantly implicated in obesity. Due to the multifaceted characterization of fatty liver and no effective treatment, this study was aimed to assess the protective effect of a polysaccharide in NAFL patients. Materials and methods: Polysaccharide fraction was isolated from Rosa canina and administered to 33 NAFL patients for 90 days. Demographic information, liver ultrasonography, and the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) enzymes were studied. Data were analyzed with the use of SPSS version 21 (SPSS, Inc.) All data were shown as means ± SDs and p < 0.05 was considered as significant. Results: After 90-day prescription, the weight loss, reduced activity of ALT and AST as well as changing the echogenicity of the liver from grades of 3, 2, and 1 to 2, 1 and normal, respectively, were observed in patients compared to the baseline (p ≤ 0.05). In ad-dition, there were no visible side effects in patients during drug consumption. Conclusions: The data indicated that polysaccharide fraction with no obvious side effects is significantly able to protect the liver from steatosis in patients with NAFL disease. However, further information is required to better conclude on the effectiveness of the isolated polysaccharide as a promising fatty liver drug. (Clin Diabetol 2022, 11; 4: 239–244)
{"title":"The Safety and Effectiveness of a Polysaccharide Extracted from Rosa Canina in Patients with NAFLD: A Randomized Trial","authors":"G. Bahrami, R. Naseri, M. Khosravifar, Soraya Sajadimajd, Bahareh Mohammadi, F. Heydarpour, Sanaz Cheraghialiakbari","doi":"10.5603/dk.a2022.0028","DOIUrl":"https://doi.org/10.5603/dk.a2022.0028","url":null,"abstract":"Objective: Non-alcoholic fatty liver (NAFL) is a common pathology of hepatocytes due to the accumulation of fat which is predominantly implicated in obesity. Due to the multifaceted characterization of fatty liver and no effective treatment, this study was aimed to assess the protective effect of a polysaccharide in NAFL patients. Materials and methods: Polysaccharide fraction was isolated from Rosa canina and administered to 33 NAFL patients for 90 days. Demographic information, liver ultrasonography, and the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) enzymes were studied. Data were analyzed with the use of SPSS version 21 (SPSS, Inc.) All data were shown as means ± SDs and p < 0.05 was considered as significant. Results: After 90-day prescription, the weight loss, reduced activity of ALT and AST as well as changing the echogenicity of the liver from grades of 3, 2, and 1 to 2, 1 and normal, respectively, were observed in patients compared to the baseline (p ≤ 0.05). In ad-dition, there were no visible side effects in patients during drug consumption. Conclusions: The data indicated that polysaccharide fraction with no obvious side effects is significantly able to protect the liver from steatosis in patients with NAFL disease. However, further information is required to better conclude on the effectiveness of the isolated polysaccharide as a promising fatty liver drug. (Clin Diabetol 2022, 11; 4: 239–244)","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85492989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Rajput, B. Sinha, S. Lodha, P. Deb, Sambit Das, S. Agarwal, A. Das, N. Thomas
Objective: Despite the benefit–risk ratio favoring glucagon-like peptide-1 receptor agonists (GLP-1 RAs), knowledge and awareness is lacking among patients and physicians, particularly in India. The current review provides an overview of GLP-1 RAs and the opinion of a group of healthcare practitioners (HCPs) and independent consultants across India on the evidence for using GLP-1 RAs and its applicability to the Indian population. Materials and methods: A panel of eight HCPs met virtually on December 12–13, 2020 met as part of the Diabetes Research Society (DIABAID). They examined and critically discussed the current research on the use of GLP-1 RAs in the management of T2DM. Results: The panel observed that recent diabetes guidelines and recommendations have shifted toward a more individualised and CV risk-focused approach to T2DM management. They proposed that 1) GLP-1 RAs are ideal cardio-metabolic drugs that address multiple aspects of the T2DM; 2) to bring up GLP-1 RAs as early treatment option in discussions with patients; 3) in T2DM patients with a high CV risk or established ASCVD, CKD, or HF, GLP-1 RAs with proven CVD benefits should be initiated; 4) including oral semaglutide in international treatment recommendation guidelines to improve patient and HCP understanding and adaptability; and 5) patient-physician dialogues will be critical in incorporating GLP-1 RAs earlier in the treatment paradigm for effective T2DM management. Conclusions: The recommendations on using GLP-1 RAs and the associated benefits and risks of these drugs comprise essential considerations for using such medications in the Indian population. (Clin Diabetol 2022, 11; 4: 269–293)
{"title":"GLP-1 Receptor Agonists Critical Review: Revisiting Its Positioning for Type 2 Diabetes Mellitus in Routine Clinical Practice in India","authors":"R. Rajput, B. Sinha, S. Lodha, P. Deb, Sambit Das, S. Agarwal, A. Das, N. Thomas","doi":"10.5603/dk.a2022.0026","DOIUrl":"https://doi.org/10.5603/dk.a2022.0026","url":null,"abstract":"Objective: Despite the benefit–risk ratio favoring glucagon-like peptide-1 receptor agonists (GLP-1 RAs), knowledge and awareness is lacking among patients and physicians, particularly in India. The current review provides an overview of GLP-1 RAs and the opinion of a group of healthcare practitioners (HCPs) and independent consultants across India on the evidence for using GLP-1 RAs and its applicability to the Indian population. Materials and methods: A panel of eight HCPs met virtually on December 12–13, 2020 met as part of the Diabetes Research Society (DIABAID). They examined and critically discussed the current research on the use of GLP-1 RAs in the management of T2DM. Results: The panel observed that recent diabetes guidelines and recommendations have shifted toward a more individualised and CV risk-focused approach to T2DM management. They proposed that 1) GLP-1 RAs are ideal cardio-metabolic drugs that address multiple aspects of the T2DM; 2) to bring up GLP-1 RAs as early treatment option in discussions with patients; 3) in T2DM patients with a high CV risk or established ASCVD, CKD, or HF, GLP-1 RAs with proven CVD benefits should be initiated; 4) including oral semaglutide in international treatment recommendation guidelines to improve patient and HCP understanding and adaptability; and 5) patient-physician dialogues will be critical in incorporating GLP-1 RAs earlier in the treatment paradigm for effective T2DM management. Conclusions: The recommendations on using GLP-1 RAs and the associated benefits and risks of these drugs comprise essential considerations for using such medications in the Indian population. (Clin Diabetol 2022, 11; 4: 269–293)","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79423496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Roya Mehdizade Tazangi, M. Bijani, Shahnaz Karimi, M. Naghizadeh, A. K. Jeihooni, Mohammadhossein Rahimzahedi
Objective: The present study was aimed at investigat-ing the effect of peer group-based training (PGBT) using the health belief model (HBM) on the quality of life (QOL) and foot ulcer self-care behavior in patients with type 2 diabetes. Materials and methods: The present study was a randomized controlled clinical trial performed on patients with type 2 diabetes who were referred to the Diabetic Care Clinic in Shiraz (Iran) from September 2019 to June 2020. A total of 70 patients participated in the study and were randomly assigned to peer training (n = 35) and control groups (n = 35). Diabetes Quality of Life, and diabetes self-care behaviors, which were completed by both groups before, immediately, 1 month, and 3 months after the intervention. The data were analyzed using the Chi-square test, paired t-test, independent t-test, ANOVA, and descriptive statistical methods. P < 0.05 was considered statistically significant. Results: The results showed that mean scores of QOL, constructs of HBM (awareness, perceived susceptibility, perceives severity, perceived benefit, self-care behavior, and foot care) before the intervention did not reveal a significant difference between the two groups, but immediately one month after the educational intervention, the mean values for the intervention group were significantly higher than the control group (p < 0.05). Conclusion: PGBT using HBM was effective in increasing the mean score of QOL and self-care behavior in patients with type 2 diabetes. Thus, this method is recommended to be utilized alongside other methods to train patients. (Clin Diabetol 2022, 11; 4: 251–261)
{"title":"The Effect of Peer Group-Based Training Using Health Belief Model on Quality of Life and Foot Ulcer Self-Care Behaviour in Patients with Type 2 Diabetes: A Randomized Controlled Clinical Trial","authors":"Roya Mehdizade Tazangi, M. Bijani, Shahnaz Karimi, M. Naghizadeh, A. K. Jeihooni, Mohammadhossein Rahimzahedi","doi":"10.5603/dk.a2022.0031","DOIUrl":"https://doi.org/10.5603/dk.a2022.0031","url":null,"abstract":"Objective: The present study was aimed at investigat-ing the effect of peer group-based training (PGBT) using the health belief model (HBM) on the quality of life (QOL) and foot ulcer self-care behavior in patients with type 2 diabetes. Materials and methods: The present study was a randomized controlled clinical trial performed on patients with type 2 diabetes who were referred to the Diabetic Care Clinic in Shiraz (Iran) from September 2019 to June 2020. A total of 70 patients participated in the study and were randomly assigned to peer training (n = 35) and control groups (n = 35). Diabetes Quality of Life, and diabetes self-care behaviors, which were completed by both groups before, immediately, 1 month, and 3 months after the intervention. The data were analyzed using the Chi-square test, paired t-test, independent t-test, ANOVA, and descriptive statistical methods. P < 0.05 was considered statistically significant. Results: The results showed that mean scores of QOL, constructs of HBM (awareness, perceived susceptibility, perceives severity, perceived benefit, self-care behavior, and foot care) before the intervention did not reveal a significant difference between the two groups, but immediately one month after the educational intervention, the mean values for the intervention group were significantly higher than the control group (p < 0.05). Conclusion: PGBT using HBM was effective in increasing the mean score of QOL and self-care behavior in patients with type 2 diabetes. Thus, this method is recommended to be utilized alongside other methods to train patients. (Clin Diabetol 2022, 11; 4: 251–261)","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84321037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Vitamin D and Diabetes: Association vs. Causation?","authors":"A. V. Raveendran","doi":"10.5603/dk.a2022.0038","DOIUrl":"https://doi.org/10.5603/dk.a2022.0038","url":null,"abstract":"","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85183419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
F. Afsharpour, M. Javadi, S. Hashemipour, Y. Koushan, Hossein Khadem Haghighian
{"title":"Changes in Lipid Profile, Liver Enzymes and Inflammatory Factors Following Oral Supplementation with Propolis in Patients with Type 2 Diabetes","authors":"F. Afsharpour, M. Javadi, S. Hashemipour, Y. Koushan, Hossein Khadem Haghighian","doi":"10.5603/dk.a2022.0033","DOIUrl":"https://doi.org/10.5603/dk.a2022.0033","url":null,"abstract":"","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72926653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
I. Paulus, Jourdan Wirasugianto, N. L. P. P. Sanjiwani, I. Supadmanaba, I. Semadi, K. Suastika
{"title":"Association between Hyperglycemic Crisis with Major Cardiovascular Events in Patients with Diabetes: A Single Center Retrospective Cohort Study","authors":"I. Paulus, Jourdan Wirasugianto, N. L. P. P. Sanjiwani, I. Supadmanaba, I. Semadi, K. Suastika","doi":"10.5603/dk.a2022.0019","DOIUrl":"https://doi.org/10.5603/dk.a2022.0019","url":null,"abstract":"","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80852416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gemigliptin (LC15-0444) is a competitive, reversible (fast association and slow dissociation), selective (> 3000-fold against DPP-8/9), and long-acting (halflife 30.8 hours) dipeptidyl peptidase-4 (DPP-4) inhibitor, first approved for clinical use by the Korean Food and Drug Administration (FDA) in 2012. It has been approved to be taken orally, with or without food, at a dose of 50 mg once daily, either as monotherapy or in combination with other drugs, and no dose adjustment is required in patients with renal or hepatic impairment. While DPP-4 inhibition with gemigliptin in experimental animal studies was found to be 80%, the fast association and slow dissociation kinetics of DPP-4 inhibition with gemigliptin were found to be albeit different compared with sitagliptin (fast on and fast off rate) and vildagliptin (slow on and slow off rate). Although the originator LG Life Sciences initially signed a licensing agreement with developers such as Sanofi (France) and Stendhal (Mexico) for 104 countries, gemigliptin has been currently approved in 11 countries including India, Columbia, Costa Rica, Panama, Ecuador, Russia, Mexico, and Thailand beside South Korea. In this issue of Clinical Diabetology, a real-world, 12-week, small study (n = 60), of gemigliptin by Sarkar et al. [1] from the Eastern part of India conducted during 2016–2017, reported a robust –1.25% (95% confidence interval, –1.59 to –0.92) HbA1c reduction with gemigliptin in people with type 2 diabetes (median age 52.2 years with a mean HbA1c of 9.5% and duration of diabetes of 8.6 years) on a background antidiabetic (mono, dual, triple combination) therapy but majorly (65%) on background metformin monotherapy. Moreover, 57% of patients achieved a target HbA1c of < 7% with the addition of gemigliptin. The larger HbA1c lowering effect of gemigliptin in this real-world study could be due to a higher baseline mean HbA1c of 9.5% but this appears to be > 2-fold higher than the HbA1c lowering effect observed in the randomized controlled trials (RCTs) conducted in Indian patients. In the subgroup analysis of a double-blind RCT [2], the HbA1c lowering effect of gemigliptin was lower in 108 Indian patients compared with 74 Korean patients (–0.55% vs. –0.94%, respectively) against placebo, despite a higher mean baseline HbA1c (including a higher percentage of patients with baseline HbA1c of > 8.5%) in Indians compared to the Koreans. This suggests real-world studies could often overestimate the effect size related to its inherent bias. Interestingly, the sojourn of gemigliptin did not last long (launched in India in April 2016) and it was withdrawn from India in July 2018 by the Sanofi for unknown or perhaps commercial reasons related to its cost. Notably, the cost of gemigliptin (not approved by the USA FDA and with no cardiovascular (CV) outcome trial (CVOT) conducted) was nearly similar to another DPP-4 inhibitor sitagliptin (US FDA-approved) with clean cardiovascular (CV) safety data shown in
{"title":"Sojourn of Gemigliptin: A Hidden Gem?","authors":"A. Singh","doi":"10.5603/dk.a2022.0027","DOIUrl":"https://doi.org/10.5603/dk.a2022.0027","url":null,"abstract":"Gemigliptin (LC15-0444) is a competitive, reversible (fast association and slow dissociation), selective (> 3000-fold against DPP-8/9), and long-acting (halflife 30.8 hours) dipeptidyl peptidase-4 (DPP-4) inhibitor, first approved for clinical use by the Korean Food and Drug Administration (FDA) in 2012. It has been approved to be taken orally, with or without food, at a dose of 50 mg once daily, either as monotherapy or in combination with other drugs, and no dose adjustment is required in patients with renal or hepatic impairment. While DPP-4 inhibition with gemigliptin in experimental animal studies was found to be 80%, the fast association and slow dissociation kinetics of DPP-4 inhibition with gemigliptin were found to be albeit different compared with sitagliptin (fast on and fast off rate) and vildagliptin (slow on and slow off rate). Although the originator LG Life Sciences initially signed a licensing agreement with developers such as Sanofi (France) and Stendhal (Mexico) for 104 countries, gemigliptin has been currently approved in 11 countries including India, Columbia, Costa Rica, Panama, Ecuador, Russia, Mexico, and Thailand beside South Korea. In this issue of Clinical Diabetology, a real-world, 12-week, small study (n = 60), of gemigliptin by Sarkar et al. [1] from the Eastern part of India conducted during 2016–2017, reported a robust –1.25% (95% confidence interval, –1.59 to –0.92) HbA1c reduction with gemigliptin in people with type 2 diabetes (median age 52.2 years with a mean HbA1c of 9.5% and duration of diabetes of 8.6 years) on a background antidiabetic (mono, dual, triple combination) therapy but majorly (65%) on background metformin monotherapy. Moreover, 57% of patients achieved a target HbA1c of < 7% with the addition of gemigliptin. The larger HbA1c lowering effect of gemigliptin in this real-world study could be due to a higher baseline mean HbA1c of 9.5% but this appears to be > 2-fold higher than the HbA1c lowering effect observed in the randomized controlled trials (RCTs) conducted in Indian patients. In the subgroup analysis of a double-blind RCT [2], the HbA1c lowering effect of gemigliptin was lower in 108 Indian patients compared with 74 Korean patients (–0.55% vs. –0.94%, respectively) against placebo, despite a higher mean baseline HbA1c (including a higher percentage of patients with baseline HbA1c of > 8.5%) in Indians compared to the Koreans. This suggests real-world studies could often overestimate the effect size related to its inherent bias. Interestingly, the sojourn of gemigliptin did not last long (launched in India in April 2016) and it was withdrawn from India in July 2018 by the Sanofi for unknown or perhaps commercial reasons related to its cost. Notably, the cost of gemigliptin (not approved by the USA FDA and with no cardiovascular (CV) outcome trial (CVOT) conducted) was nearly similar to another DPP-4 inhibitor sitagliptin (US FDA-approved) with clean cardiovascular (CV) safety data shown in ","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82490332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Tripathi, S. Jindal, M. Chawla, Arvind Gupta, S. Jha, U. Phadke, T. Lathia
Introduction: In recent times, traditional self-monitor-ing of blood glucose (SMBG) using fingerstick capillary samples is moving to continuous glucose monitoring (CGM) due to inherent limitations of the traditional methods. CGM displays current glucose level, trends, rate of change, time-in-range (TIR), and glucose variability (GV) over a period of several days. It detects episodes of hyperglycemia and hypoglycemia, which allows immediate response to prevent these episodes. It also allows physicians to provide a personalized glycemic response to the patients. Materials and methods: Though CGM systems have been available for more than 20 years, their use is quite low. It is challenging for clinicians to invest time in learning and understanding the diverse reports of the various CGM devices. Moreover, there is a lack of consensus on the frequency of TIR measurement. Hence. a review of the literature was performed and existing guidelines from India and abroad were reviewed for a need for CGM and its frequency of measurements in DM patients. Results: TIR is inversely correlated to the risk of mi crovascular and macrovascular complications. CGM is recommended by expert clinician consensus and national and international medical organizations. For the patients use of CGMs involves cost. Besides, there is the discomfort and inconvenience of wearing the device. Hence, defining the implications of using CGM in practice is important. According to the 2020 recommendations by the Research Society for the Study of Diabetes in India (RSSDI) — Endocrine Society of India (ESI) and the 2019 recommendations by an expert group of endocrinologists and diabetologists, in the Indian context, CGM could be suggested for patients with Type 2 Diabetes who encounter severe hyper glycemia or hypoglycemia, repeated hypoglycemia, asymptomatic hypoglycemia, nocturnal hypoglyce -mia, refractory hyperglycemia, or large blood glucose excursions. Conclusions: The role of CGM to achieve better glyce mic control and prevention of complications in T1D and T2D is well established. Significant education and awareness on CGM needs to be provided to physicians as well as patients with high GV and those on insulin therapy. (Clin Diabetol 2022, 11; 3: 192–199) diabetes in clinical practice, particularly patients not adherent to medications and lifestyle modifications
{"title":"The Implication of Time-in-Range for the Management of Diabetes in India: A Narrative Review","authors":"S. Tripathi, S. Jindal, M. Chawla, Arvind Gupta, S. Jha, U. Phadke, T. Lathia","doi":"10.5603/dk.a2022.0018","DOIUrl":"https://doi.org/10.5603/dk.a2022.0018","url":null,"abstract":"Introduction: In recent times, traditional self-monitor-ing of blood glucose (SMBG) using fingerstick capillary samples is moving to continuous glucose monitoring (CGM) due to inherent limitations of the traditional methods. CGM displays current glucose level, trends, rate of change, time-in-range (TIR), and glucose variability (GV) over a period of several days. It detects episodes of hyperglycemia and hypoglycemia, which allows immediate response to prevent these episodes. It also allows physicians to provide a personalized glycemic response to the patients. Materials and methods: Though CGM systems have been available for more than 20 years, their use is quite low. It is challenging for clinicians to invest time in learning and understanding the diverse reports of the various CGM devices. Moreover, there is a lack of consensus on the frequency of TIR measurement. Hence. a review of the literature was performed and existing guidelines from India and abroad were reviewed for a need for CGM and its frequency of measurements in DM patients. Results: TIR is inversely correlated to the risk of mi crovascular and macrovascular complications. CGM is recommended by expert clinician consensus and national and international medical organizations. For the patients use of CGMs involves cost. Besides, there is the discomfort and inconvenience of wearing the device. Hence, defining the implications of using CGM in practice is important. According to the 2020 recommendations by the Research Society for the Study of Diabetes in India (RSSDI) — Endocrine Society of India (ESI) and the 2019 recommendations by an expert group of endocrinologists and diabetologists, in the Indian context, CGM could be suggested for patients with Type 2 Diabetes who encounter severe hyper glycemia or hypoglycemia, repeated hypoglycemia, asymptomatic hypoglycemia, nocturnal hypoglyce -mia, refractory hyperglycemia, or large blood glucose excursions. Conclusions: The role of CGM to achieve better glyce mic control and prevention of complications in T1D and T2D is well established. Significant education and awareness on CGM needs to be provided to physicians as well as patients with high GV and those on insulin therapy. (Clin Diabetol 2022, 11; 3: 192–199) diabetes in clinical practice, particularly patients not adherent to medications and lifestyle modifications","PeriodicalId":10386,"journal":{"name":"Clinical Diabetology","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2022-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75629459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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