Diabetes Therapy最新文献

{"title":"Preferences, Expectations and Attitudes on Basal Insulin from Patient-Physician-Payer Perspective: A Multi-stakeholder Survey by the Italian Diabetes Society (ITA4P Study).","authors":"Gian Paolo Fadini, Stefano Ciardullo, Gianluca Perseghin, Carla Giordano, Ernesto Maddaloni, Raffaella Buzzetti, Mariangela Ghiani, Angelo Avogaro","doi":"10.1007/s13300-025-01729-4","DOIUrl":"10.1007/s13300-025-01729-4","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes management often involves complex insulin regimens, posing significant challenges for patients and healthcare systems. Weekly basal insulin formulations aim to simplify treatment, reduce injection frequency, and improve adherence and quality of life. This study explored the beliefs, preferences and attitudes of patients, physicians and payers regarding current basal insulin therapy and weekly insulin formulations.</p><p><strong>Methods: </strong>An online survey with structured questionnaires was developed for multiple stakeholders: patients with type 1 or type 2 diabetes, physicians and payers. Participants provided self-reported insights into basal insulin therapy and perceptions of weekly formulations. Results are presented in a descriptive non-analytical way.</p><p><strong>Results: </strong>A total of 1094 patients, 468 physicians and 100 payers participated. Patients reported moderate satisfaction with current insulin therapy, with lower satisfaction in type 2 diabetes (T2D). The major burdens identified were daily injections and fear of hypoglycaemia, with weekly insulin seen as a promising alternative. Physicians prioritized glycaemic control goals, while patients emphasized independence and quality of life. Payers valued adherence and hypoglycaemia avoidance but raised concerns about costs and education needs.</p><p><strong>Conclusions: </strong>According to this multi-stakeholder survey, weekly basal insulin offers a promising approach to reduce treatment burden and improve adherence and quality of life. Addressing concerns about safety, efficacy and cost will be critical to its successful adoption in clinical practice.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1241-1254"},"PeriodicalIF":3.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735780","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}

{"title":"Amylin: From Mode of Action to Future Clinical Potential in Diabetes and Obesity.","authors":"Špela Volčanšek, Andrijana Koceva, Mojca Jensterle, Andrej Janež, Emir Muzurović","doi":"10.1007/s13300-025-01733-8","DOIUrl":"10.1007/s13300-025-01733-8","url":null,"abstract":"<p><p>Precision diabetology is increasingly becoming diabetes phenotype-driven, whereby the specific hormonal imbalances involved are taken into consideration. Concomitantly, body weight-favorable therapeutic approaches are being dictated by the obesity pandemic, which extends to all diabetes subpopulations. Amylin, an anorexic neuroendocrine hormone co-secreted with insulin, is deficient in individuals with diabetes and plays an important role in postprandial glucose homeostasis, with additional potential cardiovascular and neuroprotective functions. Its actions include suppressing glucagon secretion, delaying gastric emptying, increasing energy expenditure and promoting satiety. While amylin holds promise as a therapeutic agent, its translation into clinical practice is hampered by complex receptor biology, the limitations of animal models, its amyloidogenic properties and pharmacokinetic challenges. In individuals with advanced β-cell dysfunction, supplementing insulin therapy with pramlintide, the first and currently only approved injectable short-acting selective analog of amylin, has demonstrated efficacy in enhancing both postprandial and overall glycemic control in both type 2 diabetes (T2D) and type 1 diabetes (T1D) without increasing the risk of hypoglycemia or weight gain. Current research focuses on several key strategies, from enhancing amylin stability by attaching polyethylene glycol or carbohydrate molecules to amylin, to developing oral amylin formulations to improve patients' convenience, as well as developing various combination therapies to enhance weight loss and glucose regulation by targeting multiple receptors in metabolic pathways. The novel synergistically acting glucagon-like peptide-1 (GLP-1) receptor agonist combined with the amylin agonist, CagriSema, shows promising results in both glucose regulation and weight management. As such, amylin agonists (combined with other members of the incretin class) could represent the elusive drug candidate to address the multi-hormonal dysregulations of diabetes subtypes and qualify as a precision medicine approach that surpasses the long overdue division into T1DM and T2DM. Further development of amylin-based therapies or delivery systems is crucial to fully unlock the therapeutic potential of this intriguing hormone.Graphical abstract available for this article.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1207-1227"},"PeriodicalIF":3.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958172","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}

{"title":"Association Between Type 2 Diabetes Mellitus and Heart Failure: A Retrospective Study from a Tertiary Care Diabetes Centre in India.","authors":"Rajendra Pradeepa, Thyparambil Aravindakshan PramodKumar, Ranjit Mohan Anjana, Saravanan Jebarani, Abdul Subhan Naziyagulnaaz, Sadasivam Ganesan, Natarajan Premananth, Abraham Oomman, Soumitra Kumar, Pathiyil Balagopalan Jayagopal, Gurpreet Singh Wander, Ajit Mullasari, Jagat Narula, Sanjay Jain, Onkar C Swami, Viswanathan Mohan","doi":"10.1007/s13300-025-01746-3","DOIUrl":"10.1007/s13300-025-01746-3","url":null,"abstract":"<p><strong>Introduction: </strong>The study aimed to explore the association between type 2 diabetes (T2D) and heart failure (HF) using echocardiography and NT-proBNP. The study also derived an NT-proBNP cut-off for diagnosing HF by echo in Asian Indians with T2D.</p><p><strong>Methods: </strong>A retrospective study was performed using data from individuals with T2D, aged ≥ 18 years, who visited diabetes clinics in India between March 2019 and December 2023. NT-proBNP levels were quantified by chemiluminescence, and left ventricular ejection fraction (LVEF) was assessed from echo using two-dimensional (2D) echocardiography. Heart failure was classified based on the European Society of Cardiology (ESC) guidelines. Receiver operating characteristic (ROC) curve was performed to determine the optimal NT-proBNP cut-off for diagnosing HF by echo.</p><p><strong>Results: </strong>Among the 1189 study individuals included in the study (714 men and 475 women), 5.9% were identified as having HF with reduced ejection fraction (HFrEF), 5.5% had mildly reduced ejection fraction (HFmrEF), and 14.1% had HF with preserved ejection fraction (HFpEF) while the rest (74.5%) had LVEF > 50%. Elevated NT-proBNP levels were observed in those with reduced ejection fraction. ROC analysis identified an optimal NT-proBNP threshold of 398 pg/mL for diagnosing HF, with 87% sensitivity and 78% specificity. HF prevalence increased with age, peaking at 30.6% in individuals aged 61-70 years. Women with HF had higher NT-proBNP levels than men.</p><p><strong>Conclusions: </strong>In this diabetes clinic population, 11.5% of individuals with T2D had moderate to reduced LVEF. Early identification of HF using echocardiography and NT-proBNP in a diabetes clinic could help improve prognosis.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988948","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}

{"title":"Combining GLP-1 Receptor Agonists and SGLT2 Inhibitors in Type 2 Diabetes Mellitus: A Scoping Review and Expert Insights for Clinical Practice Utilizing the Nominal Group Technique.","authors":"Carlos A Yepes-Cortés, Isabel C Cardenas-Moreno, Rodrigo Daza-Arnedo, Karen M Feriz-Bonelo, Erica Yama-Mosquera, Alex H Ramirez-Rincón, Gilberto A Castillo-Barrios, Andres F Suarez-Rodriguez, Johanna Carreño-Jiménez, Carlos E Builes-Montaño","doi":"10.1007/s13300-025-01722-x","DOIUrl":"10.1007/s13300-025-01722-x","url":null,"abstract":"<p><strong>Introduction: </strong>Treating type 2 diabetes has shifted from a gluco-centric approach to broader cardio-renal-metabolic strategy, driven by the use of disease-modifying medications. Traditionally, diabetes management has relied on stepwise medication addition based on failures in glucose control. However, the benefits and risks of combining glucagon-like peptide-1 receptor agonists (GLP1-RAs) and sodium-glucose cotransporter 2 inhibitors (SGLT2is) remain inadequately understood.</p><p><strong>Methods: </strong>This study conducted a scoping review to examine the available clinical research on the benefits and risks of combining GLP1-RAs and SGLT2is. Additionally, the nominal group technique was used to gather insights from medical experts from different areas regarding the combined therapy's daily clinical use, concerns, and limitations. The review followed the guidelines outlined in the Joanna Briggs Institute Reviewer's Manual and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews).</p><p><strong>Results: </strong>The final report includes 50 studies. The most common designs are observational studies. The median (IQR) number of patients across studies was 355 (1295). Studies reporting metabolic outcomes were the most common. The follow-up time ranges from 1.5 to 60 months. Although limited, the available evidence seems to support the combined use of GLP1-RAs and SGLT2is. The experts agreed that the underlying mechanisms appear synergistic rather than antagonistic for most outcomes.</p><p><strong>Conclusions: </strong>Combining medical therapy is common in diabetes treatment and may occur naturally in everyday practice. Limited evidence suggests that combined SGLT2is/GLP1-RAs therapy can potentially improve most but not all outcomes. Quality evidence and better-defined outcomes are paramount to guide the selection of patients for combined therapy.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"813-849"},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006584/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699973","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}

{"title":"Long- and Short-Term Cost-Effectiveness of Once-Weekly Semaglutide versus Dulaglutide for the Treatment of Type 2 Diabetes in China: A Hypothetical Modeling Exercise.","authors":"Ying Hu, Huimin Zou, Yang Shen, Qi Ni, Yijun Li, Hao Zhang, Xianwen Chen, Carolina Oi Lam Ung, Hao Hu, Yiming Mu","doi":"10.1007/s13300-025-01716-9","DOIUrl":"10.1007/s13300-025-01716-9","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to evaluate the long- and short-term cost-effectiveness of once-weekly semaglutide versus dulaglutide for treating patients with type 2 diabetes uncontrolled with metformin after the renewal of China's national reimbursement drug list.</p><p><strong>Methods: </strong>This analysis was conducted using the Institute of Health Economics Diabetes Cohort Model (IHE-DCM) to evaluate the long-term health and economic outcomes of semaglutide 0.5 mg, 1.0 mg, and dulaglutide 1.5 mg. It was performed from the perspective of the Chinese healthcare systems over a 40-year time horizon, with an annual discount rate of 5%. Baseline cohort characteristics and treatment effects were sourced from the head-to-head clinical trial SUSTAIN 7, which compared the efficacy and safety of semaglutide and dulaglutide. The analysis included direct medical costs regarding antidiabetic treatment and complication treatment. The long-term cost-effectiveness analysis used quality-adjusted life years (QALYs) as the primary health outcome. The robustness of the results was evaluated through one-way sensitivity analyses and probabilistic sensitivity analyses. The short-term cost-effectiveness analysis, focusing on the proportion of patients achieving clinical targets as the health outcome, compared the control costs of successfully treating a patient to meet clinical treatment goals between semaglutide 0.5 mg, 1.0 mg, and dulaglutide 1.5 mg over a 40-week study period.</p><p><strong>Results: </strong>Compared with dulaglutide 1.5 mg, once-weekly semaglutide 0.5 mg demonstrated an improvement of 0.08 QALYs and a reduction in total direct medical costs of 5476 Chinese yuan (CNY); Once-weekly semaglutide 1.0 mg showed an increase of 0.19 QALYs, and a decrease in total direct medical costs of 6711 CNY. Sensitivity analyses confirmed the robustness of these results. In the short-term cost-of-control study, once-weekly semaglutide 0.5 mg demonstrated lower treatment costs for all targets: the costs of control for dulaglutide 1.5 mg were 1.2-2.1 times as much as that of semaglutide 0.5 mg once weekly. Semaglutide 1.0 mg achieved similar treatment costs for the good glycemic control goal (HbA_1c < 7%) to dulaglutide 1.5 mg. However, when looking at tight glycemic control, weight management targets, and composite targets relating to weight loss, once-weekly semaglutide 1.0 mg showed lower treatment costs compared to dulaglutide 1.5 mg to bring at least one patient to achieve these targets.</p><p><strong>Conclusions: </strong>Compared to dulaglutide 1.5 mg, once-weekly semaglutide remains cost-effective for treating type 2 diabetes uncontrolled on metformin in China under the new negotiation price. However, limitations exist, including the reliance on SUSTAIN-7 data and the lack of specific utility data for the Chinese population.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"915-929"},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006588/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662760","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}

{"title":"Diabetes Educators: Understanding the Role of Finerenone in Chronic Kidney Disease Associated with Type 2 Diabetes Mellitus.","authors":"Anne M Komé, Anita Yang, Patrick Gee, Klara R Klein","doi":"10.1007/s13300-025-01705-y","DOIUrl":"10.1007/s13300-025-01705-y","url":null,"abstract":"<p><p>People living with type 2 diabetes mellitus (T2DM) are at risk of developing diabetes-related complications such as chronic kidney disease (CKD). Screening for CKD is considered the standard of diabetes care, but less than half of people living with diabetes in the United States receive guideline-directed kidney disease testing. Despite recent pharmacologic advances for the treatment of this condition, insufficient screening delays both diagnosis and treatment of diabetes-related CKD and increases the risk of poor outcomes. The nonsteroidal mineralocorticoid receptor antagonist finerenone is an orally administered drug that, when taken with the maximum tolerated dose of a renin-angiotensin-aldosterone system inhibitor, can provide kidney and cardiovascular benefits for people living with T2DM-related CKD. Yet, uptake of this drug has been slow. Increasing awareness of finerenone may encourage its use in clinical practice. Diabetes educators are healthcare professionals (HCPs) with extensive diabetes care experience who encourage diabetes self-management and provide patients with education on the prevention of diabetes-related complications. Diabetes educators bridge knowledge and care gaps among other HCPs by facilitating communication between members of the care team and raising awareness on the importance of CKD prevention and screening. Additionally, diabetes educators reinforce the clinical evidence behind available treatments to promote adherence to guidelines. Here, the evidence for finerenone in T2DM-related CKD and the role of the diabetes educator from both patient and HCP perspectives are reviewed.Graphical abstract available for this article.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"763-784"},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006591/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540523","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}

{"title":"PIONEER REAL Italy: Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes.","authors":"Roberta Manti, Salvatore De Cosmo, Paolo Desenzani, Lidia Ferrara, Angela Girelli, Giuseppe Memoli, Alessandro Bisio, Uffe Christian Braae, Alisa Deinega, Cesare Berra","doi":"10.1007/s13300-025-01719-6","DOIUrl":"10.1007/s13300-025-01719-6","url":null,"abstract":"<p><strong>Introduction: </strong>The PIONEER REAL Italy study examined the clinical outcomes associated with oral semaglutide in real-world settings.</p><p><strong>Methods: </strong>This was a multicenter, prospective, non-interventional, single-arm study in adults with type 2 diabetes (T2D) who were treatment-naive to injectable glucose-lowering medications. Participants initiated oral semaglutide at doses of 3, 7, or 14 mg, and were followed for 34-44 weeks. The primary endpoint was the change in glycated hemoglobin (HbA_1c) from baseline to the end of study (EoS). Secondary endpoints were the change in body weight (BW), the percentage of participants attaining HbA_1c < 7%, composite endpoints of HbA_1c reduction ≥ 1%-point plus BW reduction (≥ 3%/ ≥ 5%), and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.</p><p><strong>Results: </strong>Of 445 eligible participants, 398 completed the study; 351 (78.9%) remained on oral semaglutide at EoS. The median time of treatment follow-up was 40 weeks for each participant. At baseline, participants had a mean (standard deviation [SD]) age of 62.9 (10.2) years, HbA_1c of 7.8% (1.3), T2D duration of 8.0 (6.9) years, and BW of 87.8 (19.0) kg. The estimated changes (95% confidence interval) from baseline to EoS in HbA_1c and BW were - 0.9%-points (- 1.01 to - 0.82; p < 0.0001) and - 3.8 kg (- 4.45 to - 3.24; p < 0.0001), respectively. At EoS, 65.1% achieved HbA_1c < 7%; 25.5% and 19.1% reached HbA_1c reduction ≥ 1%-point plus ≥ 3% and ≥ 5% reduction in BW, respectively. DTSQ status improved significantly at EoS (estimated change + 5.24; 95% CI, 5.24 to 6.61, p < 0.0001). Of participants who remained on oral semaglutide at EoS, 72.6% received a 7-mg dose. No new safety signals were observed.</p><p><strong>Conclusions: </strong>In Italy, the real-world clinical outcomes associated with oral semaglutide in adults with T2D complemented the findings from clinical trials. This reassures oral semaglutide usage in routine clinical practice.</p><p><strong>Trial registration: </strong>NCT05230615.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1019-1032"},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006614/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699975","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}

{"title":"Knowledge, Attitudes, and Practices in Neonatal Diabetes Mellitus Management: the JEnious-NeOnatal-DIabetes (JENODI) Survey.","authors":"Maurizio Delvecchio, Claudia Piona, Agata Chobot, Laura Cudizio, Asma Deeb, Nancy Elbarbary, Tiago J Dos Santos, Abdelhadi Habeb","doi":"10.1007/s13300-025-01714-x","DOIUrl":"10.1007/s13300-025-01714-x","url":null,"abstract":"<p><strong>Introduction: </strong>We aimed to explore the knowledge, attitude, and management of neonatal diabetes mellitus (NDM) among members of the International Society for Pediatric and Adolescent Diabetes (ISPAD).</p><p><strong>Methods: </strong>Members of the society were invited to complete an online questionnaire posted on the ISPAD website.</p><p><strong>Results: </strong>We received 108 responses from 45 different countries. Of these, 103 were involved in NDM management. 87.9% of participants would start insulin at diagnosis, and 11% would prefer sulfonylurea (SU); 54.6% would start with an insulin pump, and 80.6% would use continuous glucose monitoring. Genetic testing was suggested by 97.2% (50.9% when diagnosis occurs up to 6 months, 15.7% up to 9 months, and 30.6% up to 12 months of age), while 79.6% routinely request it in clinical practice. Of the participants, 96.3% consider genetic testing necessary to identify children who can be treated with SU, and 26.9% would try SU before testing/obtaining results. Only 37% received specific training on NDM, while 44.5% felt less confident in managing patients with NDM. Incidence in the country of practice, participant's age, years of experience in the field, number of patients registered in the clinic, and number of patients with NDM followed up were associated with differences in answers.</p><p><strong>Conclusions: </strong>This survey offers the possibility of informing health providers about the awareness of different aspects of NDM management. Our results provide the opportunity to compare various aspects of diagnosis and treatment of NDM in different geographic areas. Continuous education is needed to boost physicians' confidence in managing patients with this rare form of diabetes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"885-897"},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662716","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}

{"title":"A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus.","authors":"Xuejun Victor Peng, Georgeanna Klingensmith, Daniel S Hsia, Yunlong Xie, Richard Czerniak, William V Tamborlane, Amy S Shah","doi":"10.1007/s13300-025-01700-3","DOIUrl":"10.1007/s13300-025-01700-3","url":null,"abstract":"<p><strong>Introduction: </strong>There is an unmet need for pharmacological therapies for children with type 2 diabetes mellitus (T2DM). We assessed the efficacy and safety of an oral dipeptidyl peptidase-4 inhibitor, alogliptin, 25 mg once daily (QD), as a potential treatment for pediatric patients with T2DM.</p><p><strong>Methods: </strong>This phase 3, 52-week, multicenter, randomized, double-blind, placebo-controlled trial was conducted in children and adolescents (10-17 years old) with T2DM. Participants had glycosylated hemoglobin (HbA1c) ≥ 6.5% at baseline (≥ 6.5% to < 11% without treatment or on metformin alone; ≥ 7.0% to < 11% on insulin alone or in combination with metformin). Where required, participants underwent prerandomization stabilization of their background metformin and/or insulin therapy. All received diabetes education and home glucose-monitoring training (during screening, prerandomization stabilization, and specified visits through week 26). Participants were then stratified based on previous antihyperglycemic therapy for 12 weeks before screening into schedule A (antihyperglycemic treatment-naïve) or B (metformin and/or insulin). The primary efficacy endpoint was change in HbA1c levels from baseline at week 26. Safety was assessed as a secondary endpoint at week 52.</p><p><strong>Results: </strong>Overall, 152 participants (median age, 14 years; 68.9% female) were randomized (1:1) to receive either alogliptin (n = 75) or placebo (n = 77). The majority were white (58.3%), had a body mass index of ≥ 30 kg/m² (60.3%), and had received previous antihyperglycemic therapy (82.1%). The difference in HbA1c levels from baseline to week 26 between the alogliptin and placebo groups (least squares mean change [95% confidence interval]) was 0.10 (- 0.63, 0.83; p = 0.78). There was no difference in efficacy endpoints between alogliptin and placebo across both subgroups. No new safety concerns were observed with alogliptin treatment.</p><p><strong>Conclusion: </strong>Alogliptin 25 mg QD did not significantly improve glycemic control versus placebo in pediatric patients with T2DM. Alogliptin treatment was safe and well tolerated, and no new safety concerns were observed in this study.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT02856113; EudraCT: 2015-000208-25.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"865-883"},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006607/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540522","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}

{"title":"Systematic Literature Review of the Impact of Type 2 Diabetes and Heart Failure Guideline Adherence on Clinical and Economic Outcomes.","authors":"Elena Vianini, Anuja Pandey, Catherine Rolland, Nomxolisi Ngubane, Dirk Mueller-Wieland, Jeremy Gilbert, Alhussein Ahmad","doi":"10.1007/s13300-025-01725-8","DOIUrl":"10.1007/s13300-025-01725-8","url":null,"abstract":"<p><strong>Introduction: </strong>Type 2 diabetes mellitus (T2DM) is associated with comorbidities, particularly in the cardiovascular, renal, and metabolic (CVRM) spectrum. Given the complexity of CVRM spectrum diseases and the treatment landscape, treatment guidelines have been established to assist physicians in selecting the most appropriate treatment based on not only patients' primary disease but also their comorbidities. However, the impact of adherence to treatment guidelines on associated outcomes remains unclear.</p><p><strong>Methods: </strong>A systematic literature review was conducted to evaluate the impact of guideline-based treatment on clinical, economic, and quality-of-life (QoL) outcomes and related comorbidities in the CVRM spectrum or heart failure (HF) alone in individuals with T2DM. The MEDLINE, MEDLINE In-Process, Embase, Cochrane Central Register of Controlled Trials, and EconLit electronic databases were searched to identify relevant peer-reviewed studies published in the United States, Canada, or Germany. The studies were screened and selected for inclusion or exclusion based on populations, interventions, comparators, and study design (PICOS) criteria.</p><p><strong>Results: </strong>Of the 622 records identified, 28 publications met the inclusion criteria. In total, 11 and 16 studies reported adherence to clinical guidelines for T2DM and HF management, respectively. Adherence to T2DM and HF treatment guidelines decreased all-cause mortality and all-cause hospitalizations; furthermore, adherence to T2DM guidelines decreased hospitalizations due to HF, myocardial infarction, and stroke, and reduced T2DM-related long-term complications, while adherence to HF guidelines reduced hospitalizations due to HF. Evidence gaps were identified, including the need to assess the impact of guideline adherence on economic outcomes, the impact of adherence to diagnosis and monitoring guidelines, and the impact of guideline adherence on QoL outcomes.</p><p><strong>Conclusions: </strong>Adherence to disease management guidelines improves the outcomes of patients with T2DM or HF and reduces disease-related complications and hospitalizations; however, key evidence gaps exist, particularly regarding patients with T2DM along with comorbidities in the CVRM spectrum.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"851-864"},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006579/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718306","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}