Diabetes Therapy最新文献

{"title":"A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.","authors":"Mette Søndergaard Nielsen, Lise Brøndsted, Martin Kankam, Gaetano Morelli, David Nguyen, Trine Vang Skjøth, Usha Rani Patted, Marloes van Hout","doi":"10.1007/s13300-024-01674-8","DOIUrl":"10.1007/s13300-024-01674-8","url":null,"abstract":"<p><strong>Introduction: </strong>The glucagon-like peptide-1 (GLP-1) analogue semaglutide is approved as an oral formulation for the treatment of type 2 diabetes. This study aimed to confirm bioequivalence between a new, second-generation (2G) oral semaglutide formulation (1.5, 4 and 9 mg) and the initially approved first-generation (1G) formulation (3, 7 and 14 mg).</p><p><strong>Methods: </strong>This was a randomised, multicentre, open-label, full replicate crossover study to confirm bioequivalence between 2G and 1G oral semaglutide formulations at steady-state (SS) in healthy participants (NCT05227196). Participants were recruited to three groups. In each group, participants were randomised to one of two alternating sequences comparing once-daily oral semaglutide treatment of 9 and 14 mg (group 1), 4 and 7 mg (group 2) or 1.5 and 3 mg (group 3) at SS. Treatment duration was 20 weeks, comprising four 5-week steady-state periods on alternating formulations. Repeated 24-h blood sampling at the end of each steady-state period supported pharmacokinetic analysis. Co-primary endpoints were area under the semaglutide plasma concentration-time curve during a dosing interval at SS (AUC_0-24h,SS) and maximum semaglutide plasma concentration at SS (C_{max, 0-24h,SS}). Bioequivalence for co-primary endpoints was assessed using European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA) criteria. Safety was monitored.</p><p><strong>Results: </strong>A total of 222, 201 and 123 participants were recruited into groups 1, 2 and 3, respectively. The prespecified EMA, FDA and PMDA bioequivalence criteria were met for 2G versus 1G oral semaglutide for all three dose levels (1.5 vs 3 mg, 4 vs 7 mg and 9 vs 14 mg). The safety profile of 2G oral semaglutide was consistent with 1G oral semaglutide.</p><p><strong>Conclusions: </strong>The 2G oral semaglutide formulation was confirmed as bioequivalent to 1G oral semaglutide, with no new safety concerns identified.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05227196.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"269-287"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794934/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871658","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":"Experience of People with Diabetes Treated with Insulin Delivery Systems in France: A Comparative Analysis of Multiple Daily Injections, Tubeless Pumps, Tubed Pumps, and Hybrid Closed Loops.","authors":"Jacques Beltrand, Pierre-Yves Benhamou, Carine Choleau, Ben Braithwaite, Alice Bonin, Jean-Pierre Riveline","doi":"10.1007/s13300-024-01682-8","DOIUrl":"10.1007/s13300-024-01682-8","url":null,"abstract":"<p><strong>Introduction: </strong>While people with diabetes (PWD)'s experiences with their insulin delivery systems (IDS) are frequently reported in clinical trials, few real-world data exist on the subject. This study aimed to assess the real-world experience and satisfaction with IDS in PWD.</p><p><strong>Methods: </strong>This cross-sectional survey of PWD treated with tubed or tubeless insulin pumps, hybrid closed loop (HCL) systems, or multiple daily injections (MDI) for at least 3 months ran from 4 to 16 May 2023. The questionnaire containing bespoke questions and the Insulin Delivery System Rating Questionnaire (IDSRQ) satisfaction and interference subscales was answered by subscribers of the Aide aux Jeunes Diabétiques patient association and users of the MyDiabby Healthcare web platform.</p><p><strong>Results: </strong>Of 896 analysable respondents (552 children [age 10.7 ± 3.8 years, 46.9% female, all type 1] and 344 adults [age 43.1 ± 19.3 years, 61.9% female, 87.2% type 1]), HCL and pump users reported greater satisfaction with their IDS on the IDSRQ satisfaction subscale (HCL, 70.9 ± 17.7 [n = 208]; tubeless, 66.6 ± 19.1 [n = 272]; tubed, 64.1 ± 21.6 [n = 215]) than MDI users (53.1 ± 23.0 [n = 201]; all p < 0.001). Regarding the interference subscale, tubeless pumps (31.1 ± 24.8) performed similarly to HCLs (37.0 ± 25.5; p = 0.07) and significantly better than tubed pumps (38.6 ± 26.0; p < 0.001) and MDI (42.2 ± 24.3; p < 0.001). Furthermore, 84.6% of tubeless pump users would retain their style of pump for their ideal HCL, almost twice as often as tubed pump users.</p><p><strong>Conclusion: </strong>These results demonstrate a more positive person-reported experience with HCLs or tubeless pumps than with tubed pumps or MDI, primarily due to less interference with daily life, which most tubeless pump users would like to retain when transitioning to a HCL system. Overall, this pioneering study underscores the importance of patient preferences, providing valuable information for physicians prescribing IDS, and facilitating discussions about treatment options.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"289-306"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881510","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":"Treatment Patterns and Glycaemic Control Between 2015 and 2019 in Tianjin, China: A Real-World Study of Adults with Type 2 Diabetes.","authors":"Qiumei Zhang, Yaqing Fan, Xixi Liu, Minlu Zhang, Jiewen Zhang, Qin Du, Lei Kang, Liming Chen","doi":"10.1007/s13300-024-01661-z","DOIUrl":"10.1007/s13300-024-01661-z","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes is associated with a high economic burden in China; therefore, strategies to prevent diabetes, improve glycaemic control, delay disease-related complications and maintain quality of life are essential. This study was conducted to evaluate trends in treatment patterns and glycaemic control in people with type 2 diabetes (T2D) in real-world clinical practice in Tianjin, China.</p><p><strong>Methods: </strong>This retrospective, cross-sectional, multicentre study analysed data from adults with T2D living in Tianjin, China between 2015 and 2019, based on information obtained from a regional electronic medical record database. Temporal trends in treatment patterns and glycaemic control were assessed using linear regression (continuous variables), and Cochran-Armitage (two categories) or Cochran-Mantel-Haenszel (≥ 3 categories) tests.</p><p><strong>Results: </strong>Between 2015 and 2019, data from 312,203 individuals treated at 75 hospitals were included. Over this period, there was an upward trend in the prevalence of hypertension, hyperlipidaemia, obesity, cardiovascular disease, stroke and retinopathy each year (all P < 0.001). The use of metformin or dipeptidyl peptidase-4 inhibitors increased, while thiazolidinedione, alpha-glucosidase inhibitor and glinide use decreased; the use of basal insulin (BI), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), GLP-1 RAs + BI, bolus insulin and BI + bolus insulin increased, whereas the use of premixed insulin showed a downward trend (all P < 0.001). From 2015 to 2019, an increased proportion of individuals achieved glycated haemoglobin (HbA1c) < 7% (< 53 mmol/mol; 28.1-33.7%), fasting plasma glucose (FPG) < 7 mmol/l (21.7-26.9%) and postprandial glucose (PPG) < 10 mmol/l (22.0-48.2%; all P < 0.001). There was no change in the proportion of individuals with an FPG ≥ 7 mmol/l and a PPG ≥ 10 mmol/l, while the prevalence of residual hyperglycaemia increased (P < 0.001).</p><p><strong>Conclusions: </strong>Glycaemic control improved between 2015 and 2019 in people with T2D in Tianjin, China; however, there is an unmet need for more effective glycaemic control.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1-14"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564215","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":"Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies.","authors":"Gottfried Rudofsky, Hanan Amadid, Uffe Christian Braae, Sergiu-Bogdan Catrina, Anastas Kick, Kabirdev Mandavya, Klaus Roslind, Ponnusamy Saravanan, William van Houtum, Akshay B Jain","doi":"10.1007/s13300-024-01668-6","DOIUrl":"10.1007/s13300-024-01668-6","url":null,"abstract":"<p><strong>Introduction: </strong>Oral semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA) approved for improving glycemic control in adults with type 2 diabetes (T2D). The PIONEER REAL program evaluates clinical and patient-reported outcomes of oral semaglutide treatment as part of routine clinical practice across 13 countries. Here, data from Canada, Denmark, Italy, the Netherlands, Sweden, Switzerland, and the UK are pooled and analyzed to address treatment satisfaction as well as glycated hemoglobin (HbA_1C) and body weight changes in relevant subgroup analyses.</p><p><strong>Methods: </strong>This pooled analysis encompasses seven country-specific, non-interventional, multicenter, phase 4, prospective, single-arm clinical studies assessing the use of oral semaglutide in adults with T2D. Primary endpoint was the change in HbA_1C from baseline to end of study (EOS), and secondary endpoints included changes in body weight and treatment satisfaction. For the analyses, results were stratified by age, T2D duration, and oral semaglutide dose at EOS as well as baseline HbA_1C, body weight, and body mass index.</p><p><strong>Results: </strong>Oral semaglutide treatment was initiated by 1615 participants. At EOS, 1222 (76%) participants out of the 1483 (92%) who completed the study were on treatment. Estimated changes in HbA_1C and body weight from baseline to week 38 were - 1.0%-point (95% CI - 1.08 to - 0.97; P < 0.0001) and - 5.0% (CI - 5.37 to - 4.72; P < 0.0001). Treatment satisfaction increased significantly during the study. Shorter T2D duration interacted with higher HbA_1C reduction and body weight loss. Interaction was also observed between higher baseline HbA_1C and more pronounced decrease in HbA_1C. No significant interactions were detected between clinical outcomes and age or physician setting.</p><p><strong>Conclusion: </strong>The PIONEER REAL pooled analysis shows that people initiating oral semaglutide treatment experience improved glycemic control and body weight loss across age groups and T2D duration. This occurs regardless of specialist or primary care practice setting and is accompanied by an increased treatment satisfaction.</p><p><strong>Clinical trial registrations: </strong>NCT04559815 (Canada), NCT04537637 (Denmark), NCT05230615 (Italy), NCT04601740 (the Netherlands), NCT04601753 (Sweden), NCT04537624 (Switzerland), NCT04862923 (UK).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"73-87"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11760389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616531","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":"Cardiovascular Health Metrics of Spouses of Indian Women with a History of Gestational Diabetes and Diabetes in Pregnancy: Results from CHIP-F Study.","authors":"Yashdeep Gupta, Alpesh Goyal, Samita Ambekar, Mani Kalaivani, Neerja Bhatla, Nikhil Tandon","doi":"10.1007/s13300-024-01662-y","DOIUrl":"10.1007/s13300-024-01662-y","url":null,"abstract":"<p><strong>Introduction: </strong>There are limited data on the prevalence of cardiovascular risk factors/diseases (diabetes, obesity, hypertension, and dyslipidemia) and their composite scores reflecting overall cardiovascular health among young (< 50 years old) married couples.</p><p><strong>Methods: </strong>We have an established longitudinal prospective cohort of postpartum women with a history of hyperglycemia [pre-existing diabetes (PED; n = 101), overt diabetes in pregnancy (ODiP; n = 92), gestational diabetes (GDM; n = 643)], and normoglycemia (n = 183) in pregnancy and their spouses (n = 819). In this study, we report data from baseline cross-sectional evaluation of these 819 young couples regarding the burden of cardiovascular risk factors/diseases, their concordance and associations.</p><p><strong>Results: </strong>The mean (SD) age was 33.5 (4.9) years for women and 36.9 (5.4) years for men, and the evaluation was performed at a median (IQR) postpartum interval of 30 (20-45) months. Diabetes, hypertension, obesity, and dyslipidemia were present in 25.0%, 6.9%, 25.6%, and 4.0% of women and 15.8%, 20.2%, 14.3%, and 8.2% of men, respectively. Among men, dysglycemia (diabetes/prediabetes) and adverse cardiovascular score (average/poor) showed a significant trend in progression according to the antenatal categories of their partner (highest in DIP, intermediate in GDM, and lowest in normoglycemia). The concordance was higher for adverse cardiovascular score (58.5%), overweight/obesity (48.7%), and dysglycemia (42.4%) compared to prehypertension/hypertension (29.2%) and hypercholesterolemia (8.2%). The odds ratios were significant for all associations evaluated, except for elevated blood pressure, being strongest (OR > 2.0) for overweight/obesity and adverse cardiovascular score.</p><p><strong>Conclusions: </strong>Nearly three in five young couples evaluated in the study showed concordance for adverse cardiovascular scores. The cardiovascular risk in men increased in a graded manner across the increasing severity of antenatal glycemic categories of their partners.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"29-41"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759731/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616528","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":"Risk Evaluation of Progression of Proteinuria and Renal Decline Based on a Novel Subgroup Classification in Chinese Patients with Type 2 Diabetes.","authors":"Kai Wang, Qi Qian, Chencheng Bian, Pei Sheng, Lin Zhu, Shichao Teng, Xiaofei An","doi":"10.1007/s13300-024-01667-7","DOIUrl":"10.1007/s13300-024-01667-7","url":null,"abstract":"<p><strong>Introduction: </strong>Type 2 diabetes mellitus (T2DM) is a highly heterogeneous disease with a varying risk of complications. The recent novel subgroup classification using cluster analysis contributed to the risk evaluation of diabetic complications. However, whether the subgroup classification strategy could be adopted to predict the risk of onset and progression of diabetic kidney disease (DKD) in Chinese individuals with T2DM remains to be elucidated.</p><p><strong>Methods: </strong>In this retrospective study, 612 Chinese patients with T2DM were enrolled, and the median follow-up time was 3.5 years. The T2DM subgroups were categorized by a two-step cluster analysis based on five parameters, including age at onset of diabetes, body mass index (BMI), glycosylated hemoglobin (HbA1c), homeostasis model assessment 2 of insulin resistance (HOMA2-IR), and homeostasis model assessment 2 of β-cell function (HOMA2-β). Clinical characteristics across subgroups were compared using t-tests and chi-square tests. Furthermore, multivariate logistic regression models were adopted to assess the risk of albuminuria progression and renal function decline among different subgroups.</p><p><strong>Results: </strong>The cohort was categorized into four groups: severe insulin-deficient diabetes (SIDD), with 146 patients (23.9%); mild insulin resistance (MIRD), with 81 patients (13.2%); moderate glycemic control diabetes (MGCD), with 211 patients (34.5%); and moderate weight insulin deficiency diabetes (MWIDD), with 174 patients (28.4%). The MIRD group exhibited an increased risk of progression from non-albuminuria to albuminuria as compared with the MWIDD group, with an adjusted odds ratio (OR) and 95% confidence interval (CI) of 2.92 (1.06, 8.04). The SIDD group had a higher risk of progression from micro-albuminuria to macro-albuminuria as compared with the MGCD group, with an adjusted OR and 95% CI of 3.39 (1.01, 11.41). There was no significant difference in the glomerular filtration rate (GFR) decline among all groups.</p><p><strong>Conclusion: </strong>The present study offered the first evidence for risk evaluation of the development of DKD in the novel cluster-based T2DM Chinese subgroups. It suggested that the MIRD subgroup had a higher risk of DKD onset than the MWIDD subgroup. Meanwhile, the SIDD subgroup showed a higher risk of progression of albuminuria than the MGCD subgroup. This novel classification system could be effective in predicting the risk of DKD in Chinese patients with T2DM, which could facilitate the implementation of personalized therapeutic strategies.</p><p><strong>Trial registration: </strong>This study was registered in the Chinese Clinical Trial Registry (ChiCTR2300077183).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"89-102"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647653","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":"Cardiovascular, Metabolic, and Safety Outcomes with Semaglutide by Baseline Age: Post Hoc Analysis of SUSTAIN 6 and PIONEER 6.","authors":"Stephen C Bain, Nicolas Belmar, Søren T Hoff, Mansoor Husain, Søren Rasmussen, Tina Vilsbøll, Mark C Petrie","doi":"10.1007/s13300-024-01659-7","DOIUrl":"10.1007/s13300-024-01659-7","url":null,"abstract":"<p><strong>Introduction: </strong>The high risk of cardiovascular events in people with type 2 diabetes increases with age. The cardiovascular effects of once-weekly subcutaneous and once-daily oral semaglutide versus placebo in people with type 2 diabetes at high cardiovascular risk were investigated in the SUSTAIN 6 and PIONEER 6 cardiovascular outcomes trials, respectively. It is unknown whether the effects of semaglutide are age dependent.</p><p><strong>Methods: </strong>This post hoc analysis evaluated cardiovascular, metabolic, and safety outcomes with semaglutide versus placebo in age subgroups (≤ 60; > 60 to ≤ 65; > 65 to ≤ 70; and > 70 years) pooled from SUSTAIN 6 and PIONEER 6. Major adverse cardiovascular events (composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), changes from baseline in glycated hemoglobin A_1c (HbA_1c) and body weight, and adverse events were analyzed.</p><p><strong>Results: </strong>Semaglutide reduced major adverse cardiovascular events and its components versus placebo across age subgroups (most hazard ratios < 1.0; p_interaction > 0.05). The treatment difference in HbA_1c reduction was greater in those aged ≤ 60 years than in older subgroups (p_interaction = 0.01). Reductions in body weight with semaglutide versus placebo were consistent across age subgroups (p_interaction = 0.124). Serious adverse events or severe hypoglycemic episodes did not differ between semaglutide and placebo across age subgroups.</p><p><strong>Conclusion: </strong>Semaglutide consistently reduced major adverse cardiovascular events and body weight versus placebo across age subgroups; its safety profile did not differ with age. These results suggest that relaxing HbA_1c targets based solely on age may not always be required for people with type 2 diabetes.</p><p><strong>Trial registration: </strong>SUSTAIN 6 (NCT01720446) and PIONEER 6 (NCT02692716) are registered at ClinicalTrials.gov.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"15-28"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616529","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 Impact of Comorbid Dementia and Diabetes Mellitus on Hospital Patients' Outcomes: A Systematic Review and Meta-analysis.","authors":"Kieran Gadsby-Davis, Nikki Garner, Busra Donat Ergin, Ketan Dhatariya, Michael Hornberger","doi":"10.1007/s13300-024-01672-w","DOIUrl":"10.1007/s13300-024-01672-w","url":null,"abstract":"<p><strong>Introduction: </strong>Previous reviews have demonstrated that dementia and diabetes mellitus, separately, can worsen the hospital outcomes of patients. Unfortunately, there are no systematic evaluations regarding the hospital outcomes of patients with dementia and diabetes mellitus as a comorbidity. Therefore, our review aimed to determine any differences in hospital length of stay, hospital mortality, and hospital readmission between patients with the comorbidity and patients without.</p><p><strong>Methods: </strong>Searches were conducted of Medline, CINHAL, EMBASE, PsychINFO, Web of Science and Google Scholar for original studies. All studies were quality assessed using the Joanna Briggs Institute critical appraisal tools. Where possible, studies were pooled in a meta-analysis to generate odds ratios (OR) with 95% confidence intervals (CI).</p><p><strong>Results: </strong>Sixteen studies were included in this review. When comparing patients with the comorbidity to patients with dementia, the difference in length of stay was inconclusive, and there was no difference in the odds of hospital mortality (OR = 0.98, 95% CI 0.91-1.06). However, patients with the comorbidity had increased odds of 30-day readmission compared to patients with dementia alone (OR = 1.20, 95% CI 1.14-1.26). When comparing patients with the comorbidity to patients with diabetes, those with the comorbidity had a longer length of stay and but no difference in the odds of hospital mortality (OR = 1.48, 95% CI 0.84-2.62). Additionally, those with the comorbidity may have worse readmission outcomes than those with diabetes alone.</p><p><strong>Conclusions: </strong>Our findings suggest that patients with comorbid dementia and diabetes mellitus may have worse hospital outcomes. Therefore, we recommend further research to assess these patients' hospital outcomes to resolve the discrepancies found.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"103-120"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759732/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738739","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":"Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics.","authors":"Christophe De Block, Jennifer Peleshok, John P H Wilding, Anita Y M Kwan, Neda Rasouli, Juan M Maldonado, Carol Wysham, Minzhi Liu, Grazia Aleppo, Brian D Benneyworth","doi":"10.1007/s13300-024-01660-0","DOIUrl":"10.1007/s13300-024-01660-0","url":null,"abstract":"<p><strong>Introduction: </strong>Newer incretin-based therapies for type 2 diabetes (T2D) have the potential to substantially reduce glycated hemoglobin (HbA1c) and weight with a low associated risk of hypoglycemia. This study aimed to assess the percentage of participants randomized to tirzepatide or comparator who achieved the composite endpoint of HbA1c ≤ 6.5% and weight reduction ≥ 10% without hypoglycemia across prespecified baseline characteristics: T2D duration (≤ 5, > 5-10, or > 10 years), sex, HbA1c (≤ 8.5% or > 8.5%), age (< 65 or ≥ 65 years), and body mass index (< 30, 30 to < 35, or ≥ 35 kg/m²).</p><p><strong>Methods: </strong>This post hoc analysis of SURPASS-1 through -5 evaluated adult study participants with T2D treated with tirzepatide 5, 10, or 15 mg versus placebo or active comparator. Missing HbA1c and weight values were imputed from mixed models for repeated measures. Logistic regression was used to compare tirzepatide versus comparators for the percentage of participants reaching the composite endpoint.</p><p><strong>Results: </strong>Across subgroups, the composite endpoint was achieved by a median of approximately 30%, 45%, and 54% of participants who received tirzepatide 5, 10, and 15 mg, respectively; this was consistent across baseline subgroups, except that a greater percentage of women than men achieved the composite endpoint. The most common treatment-emergent adverse events were gastrointestinal in nature.</p><p><strong>Conclusions: </strong>In this post hoc analysis, tirzepatide achieved the composite outcome of glycemic control and weight loss with no hypoglycemia, irrespective of baseline characteristics. This may help clinicians as they select suitable treatment in diverse populations.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT03954834, NCT03987919, NCT03882970. NCT03730662, and NCT04039503.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"43-71"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616533","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":"Publisher Correction to: Criteria for Personalised Choice of a Continuous Glucose Monitoring System: An Expert Opinion.","authors":"Sergio Di Molfetta, Antonio Rossi, Federico Boscari, Concetta Irace, Luigi Laviola, Daniela Bruttomesso","doi":"10.1007/s13300-024-01666-8","DOIUrl":"10.1007/s13300-024-01666-8","url":null,"abstract":"","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"135"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616534","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}