Diabetes TherapyPub Date : 2025-03-01Epub Date: 2025-01-30DOI: 10.1007/s13300-025-01696-w
Hong Wang, Quannan Zu, Ming Lu, Rongfa Chen, Zhangui Tang, Zhiren Yang
{"title":"Cardiovascular Outcomes in Patients with Complex Type 2 Diabetes Mellitus Treated with the Dual SGLT Inhibitor Sotagliflozin: A Meta-analysis.","authors":"Hong Wang, Quannan Zu, Ming Lu, Rongfa Chen, Zhangui Tang, Zhiren Yang","doi":"10.1007/s13300-025-01696-w","DOIUrl":"10.1007/s13300-025-01696-w","url":null,"abstract":"<p><strong>Introduction: </strong>Scientific publications have shown sodium-glucose co-transporter-2 (SGLT2) inhibitors to have several beneficial effects in patients with complex type 2 diabetes mellitus (T2DM). However, sodium-glucose co-transporter-1 (SGLT-1) inhibitor is still under investigation in clinical trials. Recently, a dual inhibitor of sodium-glucose co-transporter (SGLT1/2), sotagliflozin, has been approved for use in patients with T2DM. In this analysis, we aimed to systematically compare the cardiovascular outcomes in patients with complex T2DM who were treated with the newly approved dual (SGLT 1 and 2) inhibitor sotagliflozin.</p><p><strong>Methods: </strong>Electronic databases, including Embase, MEDLINE, http://www.</p><p><strong>Clinicaltrials: </strong>gov , Web of Science, Google Scholar, the Cochrane database, and reference lists of relevant publications, were searched for publications comparing the novel SGLT1/2 inhibitor versus placebo for the treatment of patients with complex T2DM. The primary endpoint, including total number of deaths from cardiovascular causes, hospitalization for heart failure, and urgent visits for heart failure, death from cardiovascular causes, cardiac mortality, hospitalization for heart failure, non-fatal myocardial infarction, and total number of cardiac events, were considered as the endpoints in this analysis. The RevMan software version 5.4 was used to carry out the statistical analysis. Risk ratios (RR) with 95% confidence intervals (CI) were used to represent the data following analysis.</p><p><strong>Results: </strong>A total of 13,054 participants enrolled between 2017 and 2020 were included in this analysis, with 6734 participants assigned to sotagliflozin and 6320 assigned to placebo. The results of this analysis showed that the primary endpoint was significantly in favor of sotagliflozin with (RR: 0.73, 95% CI 0.67-0.80; P = 0.00001). Hospitalization for heart failure (RR: 0.67, 95% CI 0.60-0.75; P = 0.00001) and the total number of cardiac events (RR: 0.73, 95% CI 0.67-0.79; P = 0.00001) were also significantly lower with sotagliflozin when compared to placebo in these patients with complex T2DM. However, the risk for cardiovascular mortality and non-fatal myocardial infarction were not significantly different with (RR: 0.91, 95% CI 0.76-1.09; P = 0.31) and (RR: 0.92, 95% CI 0.27-3.12; P = 0.89), respectively.</p><p><strong>Conclusions: </strong>Cardiovascular outcomes, including the total number of adverse cardiac events and hospitalization for heart failure, were significantly reduced with the newly approved SGLT1/2 inhibitor sotagliflozin apparently showing its cardiovascular efficacy in patients with complex T2DM. Future trials with larger sample sizes and a longer follow-up time could possibly confirm this hypothesis.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"485-498"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064410","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}
Diabetes TherapyPub Date : 2025-03-01Epub Date: 2025-02-10DOI: 10.1007/s13300-025-01692-0
Daphne S L Gardner, Banshi Saboo, Jothydev Kesavadev, Norlaila Mustafa, Michael Villa, Edward Mahoney, Shailendra Bajpai
{"title":"Digital Health Technology in Diabetes Management in the Asia-Pacific Region: A Narrative Review of the Current Scenario and Future Outlook.","authors":"Daphne S L Gardner, Banshi Saboo, Jothydev Kesavadev, Norlaila Mustafa, Michael Villa, Edward Mahoney, Shailendra Bajpai","doi":"10.1007/s13300-025-01692-0","DOIUrl":"10.1007/s13300-025-01692-0","url":null,"abstract":"<p><p>Diabetes is a growing global health concern with a high prevalence in the Asian and Western Pacific regions. Effective diabetes management mainly relies on self-care practices. However, glycemic control remains poor, especially in developing nations where healthcare access is limited. Low physician density and minimal healthcare funding exacerbate the challenges faced by people with diabetes in Asia. Digital health technologies offer promising solutions to bridge these gaps. These technologies enhance patient engagement, improve medication adherence, and promote healthier lifestyles. Mobile apps provide tools for self-management, such as monitoring physical activity and dietary intake, while telemedicine platforms and electronic medical records facilitate patient data management and remote consultations. Despite the advantages provided by digital health technologies in managing diabetes, barriers to their adoption include infrastructure limitations, regulatory challenges, and issues with data security. Some Asian countries have made major strides in the adoption of digital health tools with national strategies and regulatory bodies to manage digital health options; however, disparities in digital health readiness persist. Effective implementation of these technologies requires addressing these barriers, including enhancing infrastructure, improving app usability, and ensuring regulatory compliance. While digital health solutions present significant opportunities, their impact depends on overcoming current challenges and ensuring equitable access and effective use in managing diabetes. Future directions should focus on prioritizing app acceptance and efficacy, as well as integrating machine learning and artificial intelligence-powered digital solutions.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"349-369"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868478/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381835","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":"Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes.","authors":"Risa Nasu, Tomonori Oura, Kenji Ohwaki, Makoto Imori, Kenichi Furihata","doi":"10.1007/s13300-025-01695-x","DOIUrl":"10.1007/s13300-025-01695-x","url":null,"abstract":"<p><strong>Introduction: </strong>This analysis aimed to assess the safety and tolerability of insulin efsitora alfa (efsitora, basal insulin Fc, LY3209590) and characterize the pharmacokinetic and pharmacodynamic profiles of efsitora in Japanese patients with type 2 diabetes.</p><p><strong>Methods: </strong>The single-dose escalation study assessed once-weekly efsitora administration in three patient cohorts: 5 mg for cohort 1; 10 mg for cohort 2 or placebo under double-blind conditions; and 20 mg for cohort 3 under open-label conditions. In the 6-week, multiple-dose study, patients started or continued using insulin degludec during the lead-in period, followed by randomization to efsitora (individualized fixed weekly dose) or insulin degludec (individualized fixed daily dose). Pharmacokinetics, pharmacodynamics, and safety were examined.</p><p><strong>Results: </strong>The mean age was 58.3 and 58.4 years, and mean body mass index was 25.6 and 26.8 kg/m<sup>2</sup> in the single-dose escalation (n = 31) and multiple-dose studies (n = 28), respectively. The pharmacokinetic profile showed a prolonged half-life of 15 to 16 days, with a low peak-to-trough ratio of 1.13 after the last dose with little fluctuation. All doses of efsitora (5, 10, and 20 mg) decreased mean fasting glucose levels from baseline to day 15 (single-dose study), with no notable changes observed after switching from insulin degludec (multiple-dose study). All treatment-emergent adverse events were mild and unrelated to the study drug. No severe hypoglycemic events were reported.</p><p><strong>Conclusions: </strong>Efsitora was well tolerated, and the pharmacokinetic and pharmacodynamic profiles were consistent with findings in prior global studies, supporting the participation of Japanese patients in phase 3 studies.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT03603704; NCT04276428.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"513-526"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381837","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":"The Long-Term Cost-Effectiveness of Tirzepatide 5 mg versus Dulaglutide 0.75 mg for the Treatment of People with Type 2 Diabetes in Japan.","authors":"Toshihiko Aranishi, Ataru Igarashi, Kazuo Hara, Beatrice Osumili, Zhihong Cai, Aska Mizogaki, Manaka Sato, Masakazu Takeuchi, Alice Minghetti, Barnaby Hunt, Takashi Kadowaki","doi":"10.1007/s13300-024-01675-7","DOIUrl":"10.1007/s13300-024-01675-7","url":null,"abstract":"<p><strong>Introduction: </strong>This analysis aimed to evaluate the long-term cost-effectiveness of tirzepatide 5 mg versus dulaglutide 0.75 mg (both administered once weekly) in people not achieving glycemic control on metformin, based on the results of the head-to-head SURPASS J-mono trial from a Japanese healthcare payer perspective.</p><p><strong>Methods: </strong>A cost-utility analysis was performed over a 50-year time horizon using an implementation of the UKPDS Outcomes Model 2 developed in Microsoft Excel. Baseline cohort characteristics, treatment effects and adverse event rates were sourced from the SURPASS J-mono trial. Simulated patients were assumed to receive either tirzepatide 5 mg or dulaglutide 0.75 mg until HbA1c exceeded 8.0%, at which point treatment was discontinued and basal insulin was initiated. Direct costs were derived from the Japan Medical Data Center claims database. Future costs and clinical benefits were discounted at 2% annually.</p><p><strong>Results: </strong>In this cost-utility modeling analysis, tirzepatide 5 mg was associated with lower diabetes-related complication rates, improved life expectancy, improved quality-adjusted life expectancy and higher direct costs versus dulaglutide 0.75 mg. This resulted in an incremental cost-effectiveness ratio (ICER) of JPY (Japanese yen) 1,302,240 per quality-adjusted life year (QALY) gained for tirzepatide 5 mg versus dulaglutide 0.75 mg (JPY 140 = USD 1). Tirzepatide remained cost-effective versus dulaglutide over a range of sensitivity analyses.</p><p><strong>Conclusions: </strong>In this analysis, tirzepatide 5 mg was associated with an ICER below the commonly quoted willingness-to-pay threshold of JPY 5,000,000 per QALY gained, suggesting that tirzepatide is a cost-effective treatment option for adult patients with type 2 diabetes mellitus, compared with dulaglutide 0.75 mg.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"431-445"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868005/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871662","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}
Diabetes TherapyPub Date : 2025-03-01Epub Date: 2025-02-06DOI: 10.1007/s13300-025-01698-8
Laurence Kessler, Charles Thivolet, Alfred Penfornis, Didier Gouet, Christine Coffin, Myriam Moret, Sophie Borot, Saïd Bekka, Emmanuel Sonnet, Michael Joubert, Sandrine Lablanche, Geoffrey Burtin, Fabio Di Piazza, Tim van den Heuvel, Ohad Cohen
{"title":"Correction to: Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study.","authors":"Laurence Kessler, Charles Thivolet, Alfred Penfornis, Didier Gouet, Christine Coffin, Myriam Moret, Sophie Borot, Saïd Bekka, Emmanuel Sonnet, Michael Joubert, Sandrine Lablanche, Geoffrey Burtin, Fabio Di Piazza, Tim van den Heuvel, Ohad Cohen","doi":"10.1007/s13300-025-01698-8","DOIUrl":"10.1007/s13300-025-01698-8","url":null,"abstract":"","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"429-430"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255210","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}
Diabetes TherapyPub Date : 2025-03-01Epub Date: 2025-01-11DOI: 10.1007/s13300-024-01689-1
Tianzuo Wang, Yuying Cui, Lin Liao
{"title":"Comparative Efficacy and Safety of Oral Semaglutide in Asians and Non-Asians Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.","authors":"Tianzuo Wang, Yuying Cui, Lin Liao","doi":"10.1007/s13300-024-01689-1","DOIUrl":"10.1007/s13300-024-01689-1","url":null,"abstract":"<p><strong>Introduction: </strong>More than half of diabetes patients are Asians, and their tolerance to antidiabetic drugs may differ from that of non-Asians. Oral semaglutide has recently gained attention for its advantages in glycemic and body weight control. However, its effects across different ethnic groups remain unknown.</p><p><strong>Methods: </strong>All available databases of randomized controlled trials (RCTs) on oral semaglutide in patients with type 2 diabetes mellitus were included. These databases provided detailed patient information, including HbA1c levels, body weight, and adverse events (AEs and serious adverse events [SAEs]).</p><p><strong>Results: </strong>Ten randomized controlled trials involving 7817 patients were included: six conducted in European and American populations and four in East Asian populations. In both the Asian and non-Asian patients' subgroups, oral semaglutide 3, 7, and 14 mg was more effective in reducing HbA1c than placebo, and between-subgroups analysis showed that semaglutide 3, 7, and 14 mg was more effective in reducing HbA1c in the Asian patients' subgroup than in the non-Asian patients' subgroup. There were no significant differences between subgroups in the number of patients achieving HbA1c < 5%. Non-Asian patients with type 2 diabetes showed significant weight reduction with 7 mg and 14 mg oral semaglutide, and Asian patients reduced body weight only with 14 mg oral semaglutide. Between-subgroups analysis showed that 7 mg oral semaglutide was more effective for weight reduction in non-Asian patients than in Asian patients. In the analysis of the efficacy of oral semaglutide at weeks 26 and 52 in Asian and non-Asian patients, in Asian patients, the hypoglycemic efficacy of oral semaglutide at 3-, 7-, and 14-mg doses at week 52 was significantly lower than that at week 26. In non-Asian patients, there was no significant difference in the reducing HbA1c efficacy of these doses of oral semaglutide at weeks 26 and 52. The weight-reduction efficacy of all doses of oral semaglutide did not change significantly with treatment duration in either Asian or non-Asian patients. Compared with sitagliptin, oral semaglutide was more effective in HbA1c reduction and weight reduction in both Asian and non-Asian patients. Subgroup analysis showed that compared with sitagliptin, Asian patients received oral semaglutide to achieve greater efficacy (HbA1c and weight reduction) than non-Asian patients. In the analysis of adverse events, oral semaglutide, as compared with placebo, was not associated with serious adverse events in either subgroup. The incidence of other (not including series) adverse events was significantly higher in non-Asian patients receiving 7 mg and 14 mg oral semaglutide.</p><p><strong>Conclusions: </strong>Oral semaglutide demonstrates superior efficacy in reducing HbA1c levels and a rapid onset of action in Asian patients. However, its efficacy appears to diminish with prolonged treatment in ","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"449-470"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868037/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142964030","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}
Diabetes TherapyPub Date : 2025-02-28DOI: 10.1007/s13300-025-01711-0
Neda Rasouli, John P H Wilding, Anita Y M Kwan, Jim S Paik, Palash Sharma, Jennifer Peleshok
{"title":"Tirzepatide for Older Adults with Type 2 Diabetes and Without Obesity: A Post Hoc Analysis of the SURPASS Clinical Trials.","authors":"Neda Rasouli, John P H Wilding, Anita Y M Kwan, Jim S Paik, Palash Sharma, Jennifer Peleshok","doi":"10.1007/s13300-025-01711-0","DOIUrl":"https://doi.org/10.1007/s13300-025-01711-0","url":null,"abstract":"<p><strong>Introduction: </strong>Tirzepatide, a once-weekly glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonist approved in the US for treating type 2 diabetes (T2D) and obesity, has demonstrated significant improvements in glycated hemoglobin A1c (HbA1c) and clinically meaningful weight loss in the SURPASS-1 to -5 clinical trials. This post hoc analysis examined the safety and efficacy results for tirzepatide in older participants with T2D who do not have obesity.</p><p><strong>Methods: </strong>A post hoc analysis was conducted on a subgroup of participants aged ≥ 65 years with a body mass index (BMI) < 30 kg/m<sup>2</sup> amongst the pooled SURPASS-1 through -5 clinical trial populations. Primary efficacy endpoints and safety were assessed for both this subgroup and overall pooled populations.</p><p><strong>Results: </strong>Participants aged ≥ 65 years with BMI < 30 kg/m<sup>2</sup> treated with tirzepatide experienced clinically meaningful HbA1c reduction (- 1.97 to - 2.10%) regardless of the assigned randomized maintenance dose. In contrast, a dose-proportional HbA1c decrease was observed in the overall population. Weight reduction in this subgroup was dose-proportional but numerically lower than in the overall population. Older participants without obesity were more likely to discontinue treatment due to adverse events (AEs), although the overall incidence of AEs was low in this subgroup. The incidence of hypoglycemia in this group was consistent with that of the overall cohort, regardless of concurrent insulin or sulfonylurea use.</p><p><strong>Conclusions: </strong>Tirzepatide may be an effective treatment for older adults without obesity, and in this post hoc analysis, it was associated with clinically relevant HbA1c reduction and dose-proportional weight loss without increasing hypoglycemic risk.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522947","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}
Diabetes TherapyPub Date : 2025-02-28DOI: 10.1007/s13300-025-01702-1
Mohamed Hassanein, Fatheya Alawadi, Ibrahim AlKadhim, Hazem Aly, Dalila Bajawi, Tarhan Cinar, Dinesh Dhanwal, Abdul Jabbar, Said Khader, Khaled Khudadah, Talal Muzaffar, Mary Ngome, Jalal Nafach, Amna Shaghouli
{"title":"O-SEMA-FAST: A Prospective, Non-interventional Study Investigating Oral Semaglutide Use in Adults with Type 2 Diabetes Mellitus During Ramadan.","authors":"Mohamed Hassanein, Fatheya Alawadi, Ibrahim AlKadhim, Hazem Aly, Dalila Bajawi, Tarhan Cinar, Dinesh Dhanwal, Abdul Jabbar, Said Khader, Khaled Khudadah, Talal Muzaffar, Mary Ngome, Jalal Nafach, Amna Shaghouli","doi":"10.1007/s13300-025-01702-1","DOIUrl":"https://doi.org/10.1007/s13300-025-01702-1","url":null,"abstract":"<p><strong>Introduction: </strong>Oral semaglutide, a glucagon-like peptide 1 receptor agonist, requires administration on an empty stomach with up to 120 mL of water, followed by no intake of food, beverages, or other oral medications for at least 30 min to ensure optimal absorption. These instructions can be challenging to adhere to during Ramadan when patients fast for extended periods. The O-SEMA-FAST study assessed the impact of fasting on adherence to oral semaglutide dosing instructions and its subsequent effects on glycaemic control and body weight.</p><p><strong>Methods: </strong>O-SEMA-FAST was a non-interventional, prospective study conducted in 2023 in people with type 2 diabetes mellitus (T2DM) who fasted during Ramadan and were on oral semaglutide treatment in the United Arab Emirates, Saudi Arabia, and Kuwait. Patients were followed for 20 weeks. Glycated haemoglobin (HbA1c) and body weight were measured at baseline and at the end of the study (EOS); changes were analysed by mixed models for repeated measures.</p><p><strong>Results: </strong>Among the 257 patients included in the final analysis, there was a significant reduction in HbA1c (- 0.2%-points, p = 0.01) and a notable decrease in body weight (- 2.6 kg, p < 0.0001) from baseline to EOS. Of the 215 patients who recorded administration details in their diaries, 68.4% (n = 147) adhered to dosing instructions for ≥ 80% of diary days. Baseline mean HbA1c was 6.7% in adherent patients and 7.0% in non-adherent patients. At EOS, the change in HbA1c was - 0.3%-points (95% confidence interval, CI - 0.4, - 0.2; p < 0.0001) for adherent patients and - 0.1%-points (95% CI - 0.4, 0.1; p = 0.3) for non-adherent patients. The change in body weight was - 3.2 kg (95% CI - 4.0, - 2.4; p < 0.0001) for adherent patients and - 1.6 kg (95% CI - 2.5, - 0.8; p = 0.0001) for non-adherent patients. An increase in self-reported hypoglycaemic events (HEs) was observed, but no severe events were reported. Gastrointestinal disorders were the most common adverse effects. Among patients with available data on self-reported HEs (n = 216), 67 (31.0%) experienced HEs. The mean age, HbA1c levels and T2DM duration of patients with vs without HEs were 51.0 vs 53.3 years, 6.99 vs 6.66% and 9.2 vs 7.9 years. A greater proportion of patients experiencing HEs were treated with oral antidiabetic drugs like biguanides (90.6% vs 86.7%), sodium glucose cotransporter 2 inhibitors (85.9% vs 80.7%), sulfonylureas (32.8% vs 25.9%) and dipeptidyl peptidase 4 inhibitors (20.3% vs 11.1%).</p><p><strong>Conclusion: </strong>The O-SEMA-FAST study demonstrated that most participants adhered to oral semaglutide instructions and experienced significant reductions in HbA1c and body weight. Overall, baseline characteristics were similar regardless of HEs; however, patients reporting HEs were younger, had higher HbA1c levels, longer T2DM duration and were under polypharmacy. Oral semaglutide is a suitable choice for individuals who fa","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522932","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}
Diabetes TherapyPub Date : 2025-02-28DOI: 10.1007/s13300-025-01703-0
Alejandra de Torres-Sánchez, Francisco J Ampudia-Blasco, Serafín Murillo, Virginia Bellido, Antonio J Amor, Pedro Mezquita-Raya
{"title":"Proposed Practical Guidelines to Improve Glycaemic Management by Reducing Glycaemic Variability in People with Type 1 Diabetes Mellitus.","authors":"Alejandra de Torres-Sánchez, Francisco J Ampudia-Blasco, Serafín Murillo, Virginia Bellido, Antonio J Amor, Pedro Mezquita-Raya","doi":"10.1007/s13300-025-01703-0","DOIUrl":"https://doi.org/10.1007/s13300-025-01703-0","url":null,"abstract":"<p><strong>Introduction: </strong>For decades, glycaemic variability (GV) was ignored in clinical practice because its precise assessment was challenging and there were no specific recommendations to reduce it. However, the current widespread use of continuous glucose monitoring (CGM) systems has changed this situation. Associations between high GV and risk of hypoglycaemia, onset of macro- and microvascular complications and mortality have been described in type 1 diabetes (T1D). It is therefore important to identify the causes of excessive glycaemic excursions and make recommendations for people with T1D to achieve better glycaemic management by minimising GV in both the short term and the long term.</p><p><strong>Methods: </strong>To achieve these aims, a panel comprising four endocrinologists, one diabetes nurse educator and one nutritionist worked together to reach a consensus on the detection of triggers of GV and propose clinical guidelines to reduce GV and improve glycaemic management by reducing the risk of hypoglycaemias.</p><p><strong>Results and conclusions: </strong>In total, four different areas of interest were identified, in which the insufficient education and/or training of people with T1D could lead to higher GV: physical activity; dietary habits; insulin therapy, especially when pump-based systems are not used; and other causes of GV increase. Practical, easy-to-follow recommendations to reduce GV in daily activities were then issued, with the aim of enabling people with T1D to reduce either hypoglycaemia or hyperglycaemia episodes. By doing this, their quality of life may be improved, and progression of chronic complications may be prevented or delayed.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522939","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":"Evaluation of the Regulatory Effect of the Pan-PPAR Agonist Chiglitazar on the Dawn Phenomenon.","authors":"Wenxuan Li, Yangang Wang, Chuanfeng Liu, Yongzhuo Yu, Lili Xu, Bingzi Dong","doi":"10.1007/s13300-025-01708-9","DOIUrl":"https://doi.org/10.1007/s13300-025-01708-9","url":null,"abstract":"<p><strong>Introduction: </strong>The dawn phenomenon (DP), characterized by early morning hyperglycemia, poses a significant challenge in diabetes management and is associated with increased glycemic variability and long-term complications. Despite its clinical impact, effective therapeutic strategies remain limited. Chiglitazar, a novel pan-PPAR agonist, has demonstrated benefits in improving lipid metabolism and insulin sensitivity, but its potential role in mitigating DP remains unexplored. This study evaluates the regulatory effect of chiglitazar on DP and investigates its possible mechanisms beyond lipid modulation.</p><p><strong>Methods: </strong>This retrospective observational study included 22 hospitalized diabetic patients who received chiglitazar (20 mg). Blood glucose levels at 3:00 a.m. and fasting glucose levels over three consecutive days were measured pre- and post-treatment, and the dawn phenomenon intensity was calculated. Lipid profiles were assessed to explore potential correlations with glucose changes.</p><p><strong>Results: </strong>Following chiglitazar administration, significant reductions were observed in LDL-C (43.82 ± 18.27 vs. 36.97 ± 16.90, p < 0.05), FFA (6.00 ± 2.38 vs. 5.06 ± 1.77, p < 0.05), mean 3:00 a.m. blood glucose (Z = - 2.03, p < 0.05), and fasting blood glucose (Z = - 2.96, p < 0.05). DP intensity also significantly improved (Z = - 3.48, p < 0.01). However, no significant correlation was found between glucose improvements and lipid profile changes (p > 0.05), suggesting an alternative mechanism of action.</p><p><strong>Conclusions: </strong>Chiglitazar effectively reduces DP intensity and improves glycemic control, independent of its effects on lipid metabolism. These findings suggest a potential link between chiglitazar's mechanism and circadian rhythm regulation, possibly through the modulation of REV-ERB nuclear receptors. Further research is needed to confirm this hypothesis and evaluate the long-term clinical benefits of chiglitazar in diabetes management.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522871","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}