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Comparing Cardiovascular Outcomes in New Users of Oral Semaglutide Versus Other Noninsulin Glucose-Lowering Therapies Among Adults with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease. 比较口服西马鲁肽与其他非胰岛素降糖治疗在2型糖尿病和动脉粥样硬化性心血管疾病成人患者中的心血管结局
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-17 DOI: 10.1007/s13300-026-01919-8
Xi Tan, Yuanjie Liang, Caichen Zhong, Lin Xie, Mico Guevarra, Caroline Swift, Adam de Havenon
{"title":"Comparing Cardiovascular Outcomes in New Users of Oral Semaglutide Versus Other Noninsulin Glucose-Lowering Therapies Among Adults with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease.","authors":"Xi Tan, Yuanjie Liang, Caichen Zhong, Lin Xie, Mico Guevarra, Caroline Swift, Adam de Havenon","doi":"10.1007/s13300-026-01919-8","DOIUrl":"https://doi.org/10.1007/s13300-026-01919-8","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical trials have found semaglutide reduces the risk of major adverse cardiovascular events (MACE) among people with type 2 diabetes (T2D) at high risk of MACE. Less is known about oral semaglutide's impact on real-world cardiovascular risk.</p><p><strong>Methods: </strong>This observational cohort study used administrative claims data from Optum's deidentified Clinformatics® Data Mart Database to compare 3-, modified 3-, 5-, modified 5-, and 2-point MACE, ischemic stroke (IS), myocardial infarction (MI), and all-cause and cardiovascular-related death rates among people with T2D and atherosclerotic cardiovascular disease (ASCVD) who initiated oral semaglutide vs other noninsulin glucose-lowering therapies (ONIGLTs). Cardiovascular outcomes were compared between new users of oral semaglutide and propensity score-matched new users of dipeptidyl peptidase 4 inhibitors (DPP4is) or sodium-glucose cotransporter 2 inhibitors (SGLT2is).</p><p><strong>Results: </strong>Oral semaglutide users (n = 10,878) had risk reductions of 17% and 21% in 3- and modified 3-point MACE, respectively, and significant risk reductions in 5-, modified 5-, and 2-point MACE, IS, and all-cause death vs ONIGLT users (n = 28,639). People who initiated oral semaglutide (n = 7218) had 22% and 24% lower risks of 3- and modified 3-point MACE, respectively, and significantly lower risks of 5- and modified 5-point MACE, IS, and all-cause death vs people who initiated DPP4is (n = 7218). Compared with SGLT2i users (n = 21,572), oral semaglutide users (n = 7491) had 21% and 22% lower risks of 3- and modified 3-point MACE, respectively, and significantly lower risks of 5-, modified 5-, and 2-point MACE.</p><p><strong>Conclusion: </strong>Consistent with clinical trial evidence, oral semaglutide was associated with a lower risk of cardiovascular outcomes among people with T2D and ASCVD in real-world settings.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148988405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Study Protocol for the TIGHTEN Study Comparing the Effects of Tofogliflozin and Glimepiride on Skeletal Muscle Mass in Patients with Type 2 Diabetes without Obesity: A Prospective, Multicenter, Open-Label, Randomized, Parallel Group Trial in Japan. 比较Tofogliflozin和格列美脲对2型糖尿病无肥胖患者骨骼肌质量影响的研究方案:一项在日本进行的前瞻性、多中心、开放标签、随机、平行组试验。
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-15 DOI: 10.1007/s13300-026-01920-1
Yasutaka Takeda, Tsubasa Ozawa, Maki Ikoma, Keiji Shimada, Reina Saito, Atsushi Nakagawa, Toshitaka Sawamura, Naoki Kumashiro
{"title":"Study Protocol for the TIGHTEN Study Comparing the Effects of Tofogliflozin and Glimepiride on Skeletal Muscle Mass in Patients with Type 2 Diabetes without Obesity: A Prospective, Multicenter, Open-Label, Randomized, Parallel Group Trial in Japan.","authors":"Yasutaka Takeda, Tsubasa Ozawa, Maki Ikoma, Keiji Shimada, Reina Saito, Atsushi Nakagawa, Toshitaka Sawamura, Naoki Kumashiro","doi":"10.1007/s13300-026-01920-1","DOIUrl":"https://doi.org/10.1007/s13300-026-01920-1","url":null,"abstract":"<p><strong>Introduction: </strong>Although sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with a lower risk of hypoglycemia, they may result in weight reduction, and provide additional benefits for cardiovascular disease, chronic kidney disease, and heart failure. However, their use in Japanese individuals with type 2 diabetes (T2D)-many of whom are older and without obesity-raises concerns regarding sarcopenia. This study aims to investigate the impact of the SGLT2 inhibitor tofogliflozin, compared with sulfonylurea glimepiride, on skeletal muscle mass in patients with T2D without obesity.</p><p><strong>Methods: </strong>This study is a prospective, multicenter, open-label, randomized, parallel group, comparative trial. Adult Japanese patients with T2D with a body mass index of < 25 kg/m<sup>2</sup> and a glycated hemoglobin (HbA1c) level of 7.0 to < 10.0% will be randomly assigned in a 1:1 ratio to receive tofogliflozin (20 mg orally/day) or glimepiride (0.5-4 mg orally/day) for 24 weeks. The primary endpoint is the change in total skeletal muscle mass to total body weight ratio from baseline to 24 weeks. The key secondary endpoints include the percentage change in total skeletal muscle mass to total body weight ratio and the change or percentage change in skeletal muscle mass index from baseline to 24 weeks. In total, 56 participants were calculated to be required, considering a dropout rate 15%, a two-sided alpha of 0.05, and a power of 0.9.</p><p><strong>Planned outcomes: </strong>Participant recruitment commenced in April 2024 and concluded in June 2025. The complete findings of this study are anticipated to be published in 2027. We expect that the results will elucidate the impact of SGLT2 inhibitors on skeletal muscle mass in individuals with T2D without obesity, thereby addressing concerns related to sarcopenia.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials (jRCT) (No. jRCTs041240011); registered 10 April 2024, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs041240011 .</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148976124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Performance of the i-SENS CareSens Air CGM System in Compliance with the European CGM (eCGM) Clinical Performance Criteria: A Pooled Analysis. i-SENS CareSens Air CGM系统符合欧洲CGM (eCGM)临床表现标准的性能:一项汇总分析
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-15 DOI: 10.1007/s13300-026-01917-w
Nina Jendrike, Kyung-Soo Kim, Seung-Hwan Lee, Won Sang Yoo, Cheol-Young Park, Sükrü Öter, Lorena Morent, Manuel Eichenlaub, Guido Freckmann
{"title":"Performance of the i-SENS CareSens Air CGM System in Compliance with the European CGM (eCGM) Clinical Performance Criteria: A Pooled Analysis.","authors":"Nina Jendrike, Kyung-Soo Kim, Seung-Hwan Lee, Won Sang Yoo, Cheol-Young Park, Sükrü Öter, Lorena Morent, Manuel Eichenlaub, Guido Freckmann","doi":"10.1007/s13300-026-01917-w","DOIUrl":"https://doi.org/10.1007/s13300-026-01917-w","url":null,"abstract":"<p><strong>Introduction: </strong>The eCGM designation is a recently proposed framework for the approval of continuous glucose monitoring (CGM) systems in Europe. The aim of this analysis was to assess whether the performance of the CareSens Air CGM system (i-SENS, Inc., Republic of Korea), derived from a pooled dataset comprising three clinical investigations, complies with eCGM requirements.</p><p><strong>Methods: </strong>A total of 164 participants (86% type 1 diabetes, 50% female, 66% on multiple daily injections) across the three studies contributed 17,655 data points to the data analysis. Meal and/or insulin challenges were implemented to obtain sufficient data points at comparator glucose concentrations <70 mg/dL (10.9%) and >300 mg/dL (5.7%). Measurement accuracy was assessed by applying eCGM accuracy requirements.</p><p><strong>Results: </strong>The CareSens Air CGM system complies with eCGM accuracy requirements in this data analysis. Approximately 91.0% of the CGM readings <70 mg/dL were found within ±15 mg/dL from the paired comparator value. At eu- (70-180 mg/dL) and hyperglycemic (>180 mg/dL) CGM readings, 78.6% and 84.4% of CGM readings exhibited differences ≤ ±15%. Overall, 90.3% of CGM readings were found within ±20% of the paired comparator values across the measuring range. Accuracy remained stable throughout the sensor lifetime.</p><p><strong>Conclusions: </strong>The CareSens Air CGM system is suitable for nonadjunctive insulin dosing decisions and integration with automated insulin delivery systems.</p><p><strong>Trial registration: </strong>The three studies whose data were used in this pooled analysis were registered in the Republic of Korea's Clinical Research Information Service (KCT0009215) and the German Clinical Trials Register (DRKS00028739 and DRKS00037132).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148976120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Tirzepatide Benefit for Early Glycemic and Weight Management in People with T2D in Japan: Rationale, Design, and Baseline Characteristics of T-BEAT Study. 替西肽对日本T2D患者早期血糖和体重控制的益处:T-BEAT研究的基本原理、设计和基线特征
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-08 DOI: 10.1007/s13300-026-01916-x
Hironori Waki, Hideaki Kagitani, Satoshi Osaga, Mariko Inoue, Daisuke Yabe
{"title":"Tirzepatide Benefit for Early Glycemic and Weight Management in People with T2D in Japan: Rationale, Design, and Baseline Characteristics of T-BEAT Study.","authors":"Hironori Waki, Hideaki Kagitani, Satoshi Osaga, Mariko Inoue, Daisuke Yabe","doi":"10.1007/s13300-026-01916-x","DOIUrl":"https://doi.org/10.1007/s13300-026-01916-x","url":null,"abstract":"<p><strong>Introduction: </strong>Tirzepatide has demonstrated good efficacy and safety in the management of type 2 diabetes (T2D) in clinical trials. As the importance of early intensive intervention is known, the tirzepatide benefit for early glycemic and weight management (T-BEAT) study investigated the real-world effectiveness of tirzepatide in participants with early stage T2D in Japan.</p><p><strong>Methods: </strong>This in-progress, noninterventional, multicenter, observational study assesses the glycemic control of tirzepatide (5-15 mg once weekly) or oral semaglutide (7-14 mg once daily) in participants with T2D who were naive to oral antidiabetes drugs (OADs) (diet and exercise only) or received OAD monotherapy, excluding oral semaglutide. The primary endpoint is the mean change in glycated hemoglobin (HbA1c) from baseline after up to 12 months of treatment. Patient-reported treatment satisfaction and other secondary endpoints are also being investigated. Baseline characteristics of the participants are reported.</p><p><strong>Results: </strong>In the tirzepatide group (N = 290), mean participant age was 55.2 (standard deviation [SD] 13.4) years, 45.2% were female, and the mean body weight, body mass index (BMI), and baseline HbA1c were 79.6 (SD 13.2) kg, 29.3 (SD 3.5) kg/m<sup>2</sup>, and 8.0% (SD 0.8), respectively. In the oral semaglutide group (N = 279), the mean participant age was 58.8 (SD 13.3) years, 35.5% were female, and the mean body weight, BMI, and baseline HbA1c were 77.2 (SD 12.3) kg, 28.2 (SD 3.0) kg/m<sup>2</sup>, and 7.8% (SD 0.7), respectively. In both groups, dyslipidemia was the most common comorbidity (62.1% and 67.7%); 40.7% and 38.0% of participants, respectively, concomitantly used OADs; and sodium glucose co-transporter 2 inhibitors and biguanides were the most common OADs.</p><p><strong>Conclusions: </strong>The T-BEAT study assesses the real-world effectiveness of tirzepatide over a 12-month treatment period in participants with early stage T2D. This study's results are expected to provide valuable information to physicians, enabling them to make informed decisions in routine clinical practice.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148911150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Type 2 Diabetes Mellitus and Chronic Venous Disease of the Lower Extremities: A Narrative Review. 2型糖尿病和下肢慢性静脉疾病:一个叙述性的回顾。
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-01 Epub Date: 2026-08-10 DOI: 10.1007/s13300-026-01891-3
Juan Rosas Saucedo, David González Villordo, Hugo Laparra Escareño, Norma Areli Rivera García, Luis Fernando Flota Cervera, Isaac Sinay, Juan Rosas Guzmán, Daniel Zingg
{"title":"Type 2 Diabetes Mellitus and Chronic Venous Disease of the Lower Extremities: A Narrative Review.","authors":"Juan Rosas Saucedo, David González Villordo, Hugo Laparra Escareño, Norma Areli Rivera García, Luis Fernando Flota Cervera, Isaac Sinay, Juan Rosas Guzmán, Daniel Zingg","doi":"10.1007/s13300-026-01891-3","DOIUrl":"10.1007/s13300-026-01891-3","url":null,"abstract":"<p><p>Chronic venous disease (CVD) is a highly prevalent but often under-recognized condition, affecting up to 60% of the general population. In patients with diabetes mellitus, the burden of CVD appears to be higher, with more severe clinical manifestations, suggesting shared pathophysiological mechanisms between the two disorders. This narrative review explores the relationship between diabetes mellitus and CVD, focusing on underlying mechanisms, clinical implications, and management strategies. A comprehensive review of the literature was conducted, integrating evidence from clinical studies, mechanistic research, and current guidelines. Epidemiological data indicate that diabetes mellitus is more frequently observed in patients with CVD compared with the general population (17.8% versus 8.6%; P < 0.0001). Diabetes contributes to the development and progression of CVD through multiple interconnected mechanisms, including endothelial dysfunction, chronic inflammation, oxidative stress, and microangiopathy, leading to structural and functional alterations such as valvular incompetence, venous reflux, and sustained venous hypertension, which may exceed 60 mmHg at the capillary level in advanced stages. Patients with diabetes are more likely to develop advanced manifestations, including edema, skin changes, and venous ulceration. Impaired wound healing due to microangiopathy and immune dysfunction increases the risk of infection and ulcer chronicity. In addition, the coexistence of peripheral arterial disease further complicates diagnosis and management, often resulting in mixed-etiology ulcers. Chronic venous disease and diabetes mellitus share overlapping risk factors and pathophysiological pathways that contribute to disease progression and clinical complexity. Early recognition, accurate diagnosis, and a multidisciplinary management approach are essential to improve outcomes. Targeted strategies, including glycemic control, compression therapy, lifestyle modification, and appropriate pharmacological interventions, may help reduce complications and improve quality of life in this high-risk population.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1313-1331"},"PeriodicalIF":4.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13546241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148700649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Retrospective Study of Infections and Antibiotic Susceptibility in Diabetic Foot Ulcers. 糖尿病足溃疡感染及抗生素敏感性的回顾性研究。
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-01 Epub Date: 2026-07-20 DOI: 10.1007/s13300-026-01896-y
Shuai Wang, Zunjiang Zhao, Xiangjian Meng, Hongfei Guo, Yinqiao Sun, Dalun Lv
{"title":"A Retrospective Study of Infections and Antibiotic Susceptibility in Diabetic Foot Ulcers.","authors":"Shuai Wang, Zunjiang Zhao, Xiangjian Meng, Hongfei Guo, Yinqiao Sun, Dalun Lv","doi":"10.1007/s13300-026-01896-y","DOIUrl":"10.1007/s13300-026-01896-y","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to investigate the predominant pathogenic microorganisms, antimicrobial resistance patterns, and antibiotic sensitivity profiles of diabetic foot infections in the southern region of a province in central-eastern China, thereby providing evidence-based guidance for the rational use of antibiotics for treating foot infections in patients with diabetes.</p><p><strong>Methods: </strong>A retrospective analysis was performed on the clinical data from patients with diabetic foot infections who were treated at a large tertiary hospital between 1 July 2019 and 31 July 2024. Wound specimens were collected for bacterial culture and antimicrobial susceptibility testing, and both clinical and microbiological data were analyzed.</p><p><strong>Results: </strong>A variety of pathogenic microorganisms, predominantly Gram-positive (G<sup>+</sup>) and Gram-negative (G<sup>-</sup>) bacteria, were isolated. The top five pathogens identified were Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Streptococcus agalactiae (group B), and Proteus mirabilis. As the Wagner grade increased, there was a shift in pathogens from G<sup>+</sup> to G<sup>-</sup> bacteria, along with a rise in polymicrobial infections, primarily coinfections involving G<sup>+</sup> and G<sup>-</sup> bacteria. The G<sup>+</sup> bacteria exhibited high resistance to penicillin and certain cephalosporins but remained highly sensitive to vancomycin and linezolid. G<sup>-</sup> bacteria showed increased resistance to quinolones, carbapenems, and aminoglycosides while maintaining relative sensitivity to tigecycline and polymyxins. Fungal infections were highly sensitive to commonly used antifungal agents. Overall, significant variations in resistance to antimicrobials were observed among different strains, with some exhibiting notable multidrug resistance, underscoring the high risk of empirical monotherapy.</p><p><strong>Conclusions: </strong>The issue of antimicrobial resistance in foot infections associated with diabetes mellitus is becoming increasingly severe. Clinical treatment should be guided by antimicrobial susceptibility testing to ensure rational antibiotic use, improve therapeutic outcomes, reduce the emergence of resistant bacteria, and lower recurrence rates.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1333-1354"},"PeriodicalIF":4.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13546395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148520188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trajectory of Kidney Function in T1D over Time: A Scoping Review. T1D患者肾功能随时间的变化轨迹:范围综述。
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-01 Epub Date: 2026-07-15 DOI: 10.1007/s13300-026-01899-9
Favian Co, Reid Whitlock, Arvind Katta, Carolina Aldworth, Jon Mares, Zihe Zheng, Mauricio Ferri, Nicole Askin, Navdeep Tangri
{"title":"Trajectory of Kidney Function in T1D over Time: A Scoping Review.","authors":"Favian Co, Reid Whitlock, Arvind Katta, Carolina Aldworth, Jon Mares, Zihe Zheng, Mauricio Ferri, Nicole Askin, Navdeep Tangri","doi":"10.1007/s13300-026-01899-9","DOIUrl":"10.1007/s13300-026-01899-9","url":null,"abstract":"<p><strong>Introduction: </strong>Type 1 diabetes (T1D) is associated with chronic kidney disease (CKD) and major adverse cardiovascular events (MACE). Contemporary data on the natural history of kidney function decline and the effect of therapies on slowing disease progression in T1D-related CKD are limited. We conducted a scoping review to describe the natural trajectory of kidney function and its effects in individuals with T1D in the USA.</p><p><strong>Methods: </strong>In our scoping review of observational studies and grey literature, we searched EMBASE (Ovid), Cumulative Index to Nursing and Allied Health Literature [CINAHL; Elton B. Stephens Company (EBSCO)], MEDLINE (Ovid), Scopus (Elsevier), Global Health (Ovid), and the Food and Drug Administration from inception to 25 April 2025. The study population included adults (age ≥ 18 years) with T1D in the USA. Our outcomes were change in estimated glomerular filtration rate (eGFR), urine albumin-to-creatinine ratio (UACR), MACE (myocardial infarction, ischemic stroke, cardiovascular death, unstable angina, or heart failure hospitalization), and healthcare resource use (HCRU). We screened 6437 abstracts and selected 22 texts that matched our criteria.</p><p><strong>Results: </strong>In one cohort, more than 50.0% of individuals with T1D developed moderately increased albuminuria (UACR > 30-299 mg/g) after 20 years and two cohort studies in T1D observed a progressive annual eGFR decline of 3 mL/min/1.73 m<sup>2</sup>. Five cohort studies found higher proportions of individuals with T1D experienced MACE or kidney failure versus those without T1D. Cross-sectional studies estimated total annual cost of HCRU in the USA at $17-27.8 billion for those with T1D, with annual per-patient costs ranging from $73,534-$112,833 for kidney failure and $40,889-$86,417 for components of MACE.</p><p><strong>Conclusions: </strong>T1D is associated with a high burden of CKD, MACE, and healthcare costs. A clearer understanding of the trajectory of kidney function decline in T1D would help providers and policymakers understand the impact potential therapies to treat T1D-related CKD may have on reducing the risk of kidney failure, MACE, and HCRU.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1251-1268"},"PeriodicalIF":4.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13546246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148444763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Insulin Efsitora Versus Degludec in Adults with Type 2 Diabetes Using Basal Insulin: QWINT-3 Japan Subgroup Analysis. 使用基础胰岛素的成人2型糖尿病患者的胰岛素Efsitora vs Degludec: QWINT-3日本亚组分析
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-01 Epub Date: 2026-08-07 DOI: 10.1007/s13300-026-01902-3
Hideaki Jinnouchi, Mariko Inoue, Yasushi Takita, Risa Nasu, Rebecca Threlkeld
{"title":"Insulin Efsitora Versus Degludec in Adults with Type 2 Diabetes Using Basal Insulin: QWINT-3 Japan Subgroup Analysis.","authors":"Hideaki Jinnouchi, Mariko Inoue, Yasushi Takita, Risa Nasu, Rebecca Threlkeld","doi":"10.1007/s13300-026-01902-3","DOIUrl":"10.1007/s13300-026-01902-3","url":null,"abstract":"<p><strong>Introduction: </strong>The phase 3 QWINT-3 study demonstrated that once-weekly insulin efsitora (efsitora) was noninferior to once-daily insulin degludec (degludec) in reducing glycated hemoglobin A1c (HbA1c) at week 26 (primary end point) in adults with type 2 diabetes (T2D) who had previously received insulin. A subgroup analysis of QWINT-3 participants from Japan is presented.</p><p><strong>Methods: </strong>QWINT-3 was a phase 3, multicenter, randomized, parallel-design, open-label study. Participants were randomized in a 2:1 ratio to receive efsitora or degludec. All participants from Japan were included in this preplanned subgroup analysis. End points investigated included changes in HbA1c from weeks 0 to 26 and throughout the treatment period (weeks 0-78), time spent in the glucose range from weeks 22 to 26 and during the initial dosing period (weeks 0-12), fasting blood glucose from weeks 0 to 78, and incidence and rate of hypoglycemia from weeks 0 to 78.</p><p><strong>Results: </strong>Overall, 131 participants from Japan were randomized to efsitora (n = 87) or degludec (n = 44). Demographics and baseline characteristics were balanced between treatment groups. From weeks 0 to 26, HbA1c decreased from 7.64% to 6.82% in the efsitora group and from 7.56% to 7.13% in the degludec group (estimated treatment difference: -0.31% [95% confidence interval (CI), -0.57 to -0.05]). Rates of level 2 or level 3 hypoglycemic events were generally low and similar between efsitora and degludec. From weeks 0 to 78, one severe hypoglycemic event was reported for efsitora; none were reported for degludec.</p><p><strong>Conclusions: </strong>Once-weekly efsitora was similar to once-daily degludec in lowering HbA1c in Japanese QWINT-3 participants with T2D already receiving daily basal insulin. Efficacy and safety were consistent with the overall QWINT-3 study population. This subgroup analysis suggests that efsitora is well tolerated and effective as a once-weekly basal insulin in Japanese adults with T2D inadequately controlled with daily basal insulin.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT05275400.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1407-1418"},"PeriodicalIF":4.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13546185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148683762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effects of Long-Term Lobeglitazone Treatment on Renal Function and Albuminuria in Korean Patients with Type 2 Diabetes Mellitus: A Multicenter Retrospective Observational Study (LUCKY). 洛贝列酮长期治疗对韩国2型糖尿病患者肾功能和蛋白尿的影响:一项多中心回顾性观察研究(LUCKY)
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-01 Epub Date: 2026-07-28 DOI: 10.1007/s13300-026-01898-w
Hee-Sung Kim, Chang Hee Jung, Jung-Hyun Noh, Eun-Jung Rhee, Heung-Yong Jin, In-Kyung Jeong
{"title":"Effects of Long-Term Lobeglitazone Treatment on Renal Function and Albuminuria in Korean Patients with Type 2 Diabetes Mellitus: A Multicenter Retrospective Observational Study (LUCKY).","authors":"Hee-Sung Kim, Chang Hee Jung, Jung-Hyun Noh, Eun-Jung Rhee, Heung-Yong Jin, In-Kyung Jeong","doi":"10.1007/s13300-026-01898-w","DOIUrl":"10.1007/s13300-026-01898-w","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to evaluate the long-term effects of lobeglitazone on renal function, glycemic control, metabolic parameters, and safety in Korean patients with type 2 diabetes mellitus (T2DM) treated for over 1 year.</p><p><strong>Methods: </strong>This retrospective, non-interventional, multicenter observational study was conducted at 30 institutions in South Korea. Patients with T2DM who had received lobeglitazone for at least 1 year and had available estimated glomerular filtration rate (eGFR) data were included. Primary outcomes were changes in eGFR and urinary albumin-creatinine ratio (UACR). Secondary outcomes included changes in HbA1c, body weight, lipid profiles, insulin resistance, β-cell function, and adverse events (AEs).</p><p><strong>Results: </strong>Of the 2743 enrolled patients, 2648 and 2500 were analyzed for safety and efficacy, respectively. Of 2648 patients analyzed for safety, 1655 (62.5%) were male and 993 (37.5%) were female. Baseline eGFR (82.0 ± 22.0 ml/min/1.73 m<sup>2</sup>) remained stable over 6 years across all chronic kidney disease (CKD) stages. UACR was unchanged in 77-83% of patients throughout follow-up. HbA1c significantly decreased from baseline (- 0.99% at year 1 to - 0.93% at year 6; all p < 0.0001), indicating sustained glycemic control. Lipid profiles and HOMA-IR improved, while HOMA- β remained stable. Overall, 1165 AEs occurred in 531 patients (20.05%), mostly consistent with the established safety profile; events of special interest were rare (< 1%).</p><p><strong>Conclusions: </strong>Long-term lobeglitazone treatment was not associated with deterioration of renal function or worsening of albuminuria status across all CKD stages, while demonstrating sustained glycemic efficacy and a favorable safety profile in real-world clinical practice. These findings support lobeglitazone as a clinically relevant long-term treatment option for patients with T2DM, including those with pre-existing CKD.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1355-1367"},"PeriodicalIF":4.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13546226/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148600155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Role of the Notch1 Signaling Pathway in the Pathogenesis and Treatment of Diabetic Foot: A Review. Notch1信号通路在糖尿病足发病及治疗中的作用综述
IF 4.2 3区 医学
Diabetes Therapy Pub Date : 2026-09-01 Epub Date: 2026-07-24 DOI: 10.1007/s13300-026-01893-1
Yang Zhi, Hong Weiqi, Zhou Caibo, Chen Binqi, Zeng Duo, Liu Lang
{"title":"The Role of the Notch1 Signaling Pathway in the Pathogenesis and Treatment of Diabetic Foot: A Review.","authors":"Yang Zhi, Hong Weiqi, Zhou Caibo, Chen Binqi, Zeng Duo, Liu Lang","doi":"10.1007/s13300-026-01893-1","DOIUrl":"10.1007/s13300-026-01893-1","url":null,"abstract":"<p><p>Diabetic foot (DF) is a severe and common complication of diabetes mellitus, involving peripheral neuropathy, vascular disease, immune-inflammatory disorders, and impaired tissue repair, with high amputation rates and a heavy medical burden. The Notch1 signaling pathway is highly conserved and participates in regulating cell proliferation, differentiation, apoptosis, angiogenesis, and inflammatory responses. Emerging evidence indicates that dysregulated Notch1 signaling is closely associated with the pathological progression of diabetic foot ulcers (DFU). This review systematically summarizes the role of Notch1 signaling in angiogenesis, inflammation, peripheral neuropathy, and cell fate regulation during DF pathogenesis, and discusses the potential therapeutic strategies targeting Notch1 pathway for DFU. We aim to provide new insights into the molecular mechanism and targeted therapy of DF.Infographic available for this article.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1289-1312"},"PeriodicalIF":4.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13546267/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148577509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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