Diabetes, Obesity & Metabolism最新文献

{"title":"Fotagliptin add-on therapy to metformin in patients with uncontrolled type 2 diabetes: A randomised, multicentre, double-blind, placebo-controlled, phase 3 trial.","authors":"Nan Yu, Wenjie Xu, Xiaohui Guo, Mingtong Xu, Wei Zhang, Chaoli Yan, Shuguang Pang, Xiuhai Shu, Wei Zhang, Weixia Peng, Yawei Zhang, Gaixian Li, Xin Zhang, Dongmei Zhou","doi":"10.1111/dom.16427","DOIUrl":"https://doi.org/10.1111/dom.16427","url":null,"abstract":"<p><strong>Aim: </strong>Fotagliptin is a novel dipeptidyl peptidase-4 inhibitor for glycaemic control in patients with type 2 diabetes (T2D). This trial aimed to assess the efficacy and safety of fotagliptin add-on to metformin in patients with T2D.</p><p><strong>Materials and methods: </strong>In this phase 3 randomised, double-blind, placebo-controlled study, patients with T2D who had inadequate glycaemic control using metformin alone were randomly allocated to fotagliptin or placebo at a 2:1 ratio for 24-week double-blind treatment period, followed by an open-label treatment with fotagliptin for all patients, making up a total of 52 weeks. All eligible patients were treated with a stable dose of metformin (≥1500 mg per day). The primary endpoint was the change in HbA1c level from baseline to week 24. Safety was assessed in all patients who received at least one dose of the study drug.</p><p><strong>Results: </strong>After 24 weeks, LS mean change of HbA1c from baseline was -0.81% with fotagliptin versus -0.28% with placebo. Estimated treatment difference for fotagliptin versus placebo of HbA1c was -0.53% (95% confidence interval [CI] -0.68% to -0.39%; p < 0.001). Significantly more patients on fotagliptin than on placebo achieved HbA1c < 7.0% after 24 weeks (38.7% vs. 16.9%; p < 0.001). The incidence of adverse events was similar between the two groups. No severe hypoglycaemia events were reported in patients treated with fotagliptin and metformin combined therapy.</p><p><strong>Conclusions: </strong>In patients with T2D who experienced inadequate glycaemic control with metformin, fotagliptin achieved a superior and clinically meaningful improvement in glycaemic control compared with placebo.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143951666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to Dr. Field on 'The BIG D-FOOT randomized, double-blinded, controlled trial of bio-absorbable antibiotic delivery in calcium sulphate granules for the treatment of diabetic foot osteomyelitis'.","authors":"Matteo Monami, Edoardo Mannucci","doi":"10.1111/dom.16428","DOIUrl":"https://doi.org/10.1111/dom.16428","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143957193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The BIG D-FOOT randomized, double-blinded, controlled trial of bio-absorbable antibiotic delivery in calcium sulphate granules for the treatment of diabetic foot osteomyelitis.","authors":"Benjamin C T Field","doi":"10.1111/dom.16423","DOIUrl":"https://doi.org/10.1111/dom.16423","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Social disadvantage and technology use among adults with type 1 diabetes in Quebec: A cross-sectional study using data from the Canadian T1D (BETTER) Registry.","authors":"Parisa Khodabandehloo, Patience Fakembe, Joyeuse Senga, Rayzel Shulman, Lorraine L Lipscombe, Holly O Witteman, Ananya Banerjee, Justin Presseau, Meranda Nakhla, Maman Joyce Dogba, Leif Erik Lovblom, Rémi Rabasa-Lhoret, Anne-Sophie Brazeau, Adhiyat Najam, Wajeeha Cheema, Christine MacGibbon, Alanna Weisman","doi":"10.1111/dom.16426","DOIUrl":"https://doi.org/10.1111/dom.16426","url":null,"abstract":"<p><strong>Aims: </strong>We evaluated associations between social disadvantage and insulin pump and continuous glucose monitor (CGM) use among adults with type 1 diabetes (T1D) in Quebec, Canada, where public funding is available for CGM but not for insulin pumps.</p><p><strong>Materials and methods: </strong>We conducted a cross-sectional analysis using self-reported survey data collected from April 2019 to October 2023. Primary exposures were social disadvantage indicators (Race, income, education, employment, insurance, immigration, rural/urban location). Primary outcomes were insulin pump and CGM use. Logistic regression was used to assess associations between social disadvantage indicators and the odds of insulin pump and CGM use.</p><p><strong>Results: </strong>Among 2380 adults with T1D, 37.4% used insulin pumps and 82.5% used CGM. Insulin pump use was lower among those with income <$80 000 (odds ratio [OR] 0.64 [95% confidence interval 0.50-0.82]), no post-secondary education (OR 0.62 [0.46-0.85]), non-White Race (OR 0.47 [0.30-0.73]) and public insurance (OR 0.47 [0.35-0.62]). CGM use was lower only among those with income <$80 000 (OR 0.61 [0.45-0.83]) and public insurance (OR 0.61 [0.45-0.83]). Odds of insulin pump and CGM use were successively lower with an increasing number of social disadvantage indicators. Insulin pump and CGM use were both associated with lower HbA1c but not severe hypoglycaemia or diabetes hospitalisation.</p><p><strong>Conclusions: </strong>Social disadvantage is associated with lower uptake of insulin pumps and CGM among Quebec adults with T1D, though public funding partially mitigates disparities in CGM use. Given the benefits and increasing recommendations for automated insulin delivery, strategies to increase the uptake of diabetes technologies among socially disadvantaged individuals are required.</p><p><strong>Plain language summary: </strong>Social disadvantage is linked to lower use of insulin pumps and CGM in adults with T1D in Quebec. Public funding narrows CGM disparities, but broader equity strategies are needed.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinically meaningful improvements in treatment satisfaction in insulin-naïve people with type 2 diabetes post initiation of insulin glargine 300 U/mL: A post hoc analysis of real-world ATOS study.","authors":"Frank Snoek, Gagik Galstyan, Niaz Khan, Amir Tirosh, Jothydev Kesavadev, Hernando Vargas-Uricoechea, Houssem Baghous, Maria Aileen Mabunay, Natasa Grulovic, Valerie Corp Dit Genti, Jerome Msihid, Stewart Harris","doi":"10.1111/dom.16415","DOIUrl":"https://doi.org/10.1111/dom.16415","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143951545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between the body mass index and risk of cardiovascular events in sodium-glucose cotransporter 2 inhibitor users compared with dipeptidyl-peptidase 4 inhibitor users: A nationwide cohort study in Korea.","authors":"Hwa Yeon Ko, Kyungyeon Jung, Yongtai Cho, Sungho Bea, Jae Hyun Bae, Young Min Cho, Sang Youl Rhee, Ju-Young Shin","doi":"10.1111/dom.16416","DOIUrl":"https://doi.org/10.1111/dom.16416","url":null,"abstract":"<p><strong>Aims: </strong>There is limited evidence regarding whether obesity modifies the association between the use of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and the risk of cardiovascular events. We assessed whether baseline body mass index (BMI) modifies the association between SGLT2i use and the risk of major adverse cardiovascular events (MACE) and heart failure (HF) in patients with type 2 diabetes (T2D).</p><p><strong>Materials and methods: </strong>We used the nationwide claims data of Korea (September 2014-December 2022) to construct an active-comparator, new-user cohort of patients with T2D stratified by the Asian BMI categories: normal weight, 18.5-23 kg/m²; overweight, 23-25 kg/m²; and obesity, ≥25 kg/m². New-users of SGLT2i were propensity score (PS)-matched with new-users of dipeptidyl peptidase 4 inhibitor (DPP4i) in a 1:1 ratio. The co-primary outcomes were 4-point MACE and hospitalization for HF (HHF). Patients were followed up using an as-treated exposure definition. PS-matched hazard ratios (HR) with 95% confidence intervals (CI) were estimated using the Cox model.</p><p><strong>Results: </strong>New-users of SGLT2i and DPP4i were PS-matched in a 1:1 ratio (n = 231 332 pairs; normal weight, 21 285 pairs; overweight, 35 372 pairs; and obesity, 174 675 pairs). The overall HR for the risk of MACE with SGLT2i versus DPP4i use was 0.90 (95% CI: 0.86-0.95), with no evidence of effect modification by baseline BMI (p for homogeneity = 0.27). The risk of HHF decreased in the overall cohort (HR: 0.53, 95% CI: 0.44-0.64), as well as in the obesity (HR: 0.47, 95% CI: 0.37-0.58) and overweight (HR: 0.49, 95% CI: 0.31-0.78) groups but not in the normal-weight (HR: 0.88, 95% CI: 0.59-1.31) group, with evidence of effect modification by the BMI (p for homogeneity = 0.01).</p><p><strong>Conclusions: </strong>The association between SGLT2i use and the risk of MACE and HHF was significant in patients with obesity. Baseline BMI was an effect modifier in the association between SGLT2i use and the risk of HHF, with a more pronounced association observed with increasing BMI and with no significant effect modification of the association noted in patients with normal weight.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143961341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Proposed minimum requirements for market approval of continuous glucose monitoring (CGM) systems: A viewpoint from the IFCC working group on CGM.","authors":"Stefan Pleus, Manuel Eichenlaub, Elisabet Eriksson Boija, Peter Diem, Marion Fokkert, Rolf Hinzmann, Johan Jendle, David C Klonoff, Konstantinos Makris, James H Nichols, John Pemberton, Elizabeth Selvin, Robbert J Slingerland, Andreas Thomas, Nam K Tran, Lilian Witthauer, Guido Freckmann","doi":"10.1111/dom.16420","DOIUrl":"https://doi.org/10.1111/dom.16420","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143951995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Remnant cholesterol trajectories and diabetes risk: A letter to the editor commenting on \"Changes in remnant cholesterol and the incidence of diabetes: Results from two large prospective cohort studies\".","authors":"Juan He","doi":"10.1111/dom.16430","DOIUrl":"https://doi.org/10.1111/dom.16430","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143951725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world use of liraglutide for weight management according to label in the United Kingdom: A cohort study using the Clinical Practice Research Datalink primary care databases.","authors":"Tarita Murray-Thomas, John M Dcruz, Nina M Harder-Lauridsen, Anne H Olsen, Rachael Williams, Atheline Major-Pedersen","doi":"10.1111/dom.16393","DOIUrl":"https://doi.org/10.1111/dom.16393","url":null,"abstract":"<p><strong>Aims: </strong>To assess real-world use of Saxenda® (liraglutide 3.0 mg) and off-label use of Victoza® (liraglutide 1.2 mg/1.8 mg) for weight management and Saxenda® posology in the United Kingdom. Their similar doses and formulation pose a risk of inadvertent use due to their use for different indications.</p><p><strong>Materials and methods: </strong>This retrospective, non-interventional drug utilization cohort study (DUS), based on anonymized patient data from the Clinical Practice Research Datalink databases (CPRD Aurum, GOLD), included adult liraglutide initiators without prior prescription 12 months before the index date. Descriptive statistics were used to characterize Saxenda® and Victoza® user demographics and drug utilization.</p><p><strong>Results: </strong>Totally 604 Saxenda® and 4853 Victoza® patients were included. Approximately half of the Saxenda® initiators (Si's) (N = 306) had available body weight, of which 96.4% initiated treatment according to the weight loss indication. Si's were more likely female than Victoza® initiators (Vi's) (86.4% vs. 52.1%), younger (mean age ± SD: 46.5 ± 11.7 years) versus (57.5 ± 12.0 years) and with shorter duration of follow-up observation (18.8 ± 13.9 months) versus (32.9 ± 15.9 months). N < 5 of 16 patients with 24-weeks body mass index (BMI) data did not adhere to the Saxenda® stopping rule. N < 5 of 92 patients with valid dose used Victoza® outside the diabetes indication.</p><p><strong>Conclusions: </strong>This DUS provides descriptive data for initiators of liraglutide in the initial 5-year period following the launch of Saxenda® in the United Kingdom. Real-world use of Saxenda® and Victoza® raised no new safety concerns. Where assessment was possible, Saxenda® and Victoza® were mostly prescribed by physicians according to their approved indications.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143956560","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Liraglutide improves peripheral perfusion and markers of angiogenesis and inflammation in people with type 2 diabetes and peripheral artery disease: An 18-month follow-up of a randomized clinical trial.","authors":"Paola Caruso, Maria Ida Maiorino, Miriam Longo, Antonietta Maio, Lorenzo Scappaticcio, Nicole Di Martino, Carla Carbone, Mariluce Barrasso, Mariangela Caputo, Maurizio Gicchino, Giuseppe Bellastella, Dario Giugliano, Katherine Esposito","doi":"10.1111/dom.16419","DOIUrl":"https://doi.org/10.1111/dom.16419","url":null,"abstract":"<p><strong>Aims: </strong>In a six-month randomized clinical trial, improved peripheral perfusion has been shown with liraglutide, associated with favourable vascular effects in people with type 2 diabetes and peripheral artery disease (PAD). We aimed to evaluate the durability of these benefits and to elucidate some mechanisms underlying liraglutide's effect over an 18-month follow-up.</p><p><strong>Methods: </strong>STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD. We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters. TcPO₂ was assessed with transcutaneous oximetry. Circulating levels of angiogenic progenitor cells and serum inflammation markers were evaluated by flow cytometry and enzyme-linked immunosorbent assay, respectively.</p><p><strong>Results: </strong>Compared with the control group, significant differences favouring the liraglutide group were observed at 18 months for TcPO₂ [estimated treated difference (95% CI), 10.9 mmHg (7.6 to 14.1 mmHg), p < 0.001]. At 18 months of follow-up, participants in the liraglutide group, as compared with those in the control group, had a significant reduction in urine albumin to creatinine ratio (estimated difference, -103.9 mg/g Cr, 95%CI, -170.8 to -37.1, p = 0.003), C-reactive protein (-0.5 mg/dL, 95%CI, -0.8 to -0.2, p = 0.002), as well as interleukin-6 (-32.6 pg/mL, 95%CI, -54.6 to -10.5, p = 0.004). Compared with the control group, participants in the liraglutide group showed significantly higher concentrations of circulating progenitor cells and endothelial progenitor cells at both 6 and 18 months, for CD34⁺, CD133⁺, KDR⁺, CD34⁺/KDR⁺ and CD34⁺/CD133⁺/KDR⁺. Liraglutide was also associated with a higher increase in vascular endothelial growth factor A at 18 months (70.1 pg/mL, 95%CI, 44.7 to 95.4, p < 0.001).</p><p><strong>Conclusions: </strong>In people with type 2 diabetes and PAD, liraglutide increased peripheral perfusion, with amelioration of markers of angiogenesis and inflammation over an 18-month follow-up.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143956299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}