Diabetes Therapy最新文献

{"title":"Forecasting Trial Milestones: A Predictive Analysis for Early Termination of the SOUL Study.","authors":"Binayak Sinha, Samit Ghosal","doi":"10.1007/s13300-024-01635-1","DOIUrl":"10.1007/s13300-024-01635-1","url":null,"abstract":"<p><strong>Introduction: </strong>Semaglutide, a glucagon-like peptide 1 receptor agonist (GLP1RA), is available in both parenteral and oral preparations. Studies of injectable preparations have convincingly demonstrated its beneficial effect on major adverse cardiac events (MACE). This predictive analysis was undertaken to forecast early termination of the SOUL trial (oral semaglutide) as well as the primary events.</p><p><strong>Methods: </strong>SOUL is a multicenter, double-blind, placebo-controlled randomized controlled trial (RCT) evaluating the reduction in MACE associated with oral semaglutide versus placebo in patients with type 2 diabetes (T2D) and cardiovascular (CV) disease. A sample of 9642 participants will be followed for 5 years and 5 months. A random-effects model meta-analysis, pooling hazard ratios from previous RCTs, was conducted using R software to inform the predictive model. The background CV event rates from the placebo arms of previous RCTs with semaglutide were matched with the pre-adjudicated assumptions of the SOUL trial to create the predictive model. The truncated trial duration, MACE, and its individual components in the intervention and placebo arms were estimated. The predicted difference between the two groups was estimated using the chi-squared test.</p><p><strong>Results: </strong>A pooled analysis of 10,013 patients revealed a significant reduction in the number of MACEs associated with semaglutide (HR 0.79, 95% CI 0.69-0.91). Predictive analysis indicated that 1225 events would be achieved by 3.78 years, suggesting premature termination.</p><p><strong>Conclusion: </strong>The mathematical model based on the meta-analysis predicts that the SOUL study on oral semaglutide will be terminated early, with oral semaglutide showing benefits in terms of MACE compared to placebo. If the SOUL study corroborates the findings of this model, it may not only form the basis for the calculation of power but also define the duration of such studies, reducing costs and easing the process of designing cardiovascular outcome trials (CVOTs).</p><p><strong>Protocol registration: </strong>INPLASY202460061.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11411018/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901269","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":"Transition from Paediatric to Adult Diabetes Care in People with Type 1 Diabetes: An Online Survey from France.","authors":"Juliette Eroukhmanoff, Claire Ballot Schmit, Sabine Baron, Amar Bahloul, Jacques Beltrand, Zeina Salame, Sophie Borot, Fabienne Dalla Vale, Helen Mosnier Pudar, Marc Nicolino, Alfred Penfornis, Eric Renard","doi":"10.1007/s13300-024-01630-6","DOIUrl":"10.1007/s13300-024-01630-6","url":null,"abstract":"<p><strong>Introduction: </strong>The transition from paediatric to adult diabetes care (TPA) of children/adolescents with type 1 diabetes (T1D) represents a unique challenge and remains a critical phase in the T1D care pathway. This study aims to describe and understand the experience of the transition process from a participant's perspective in young adults who are living in France with T1D and to measure their satisfaction.</p><p><strong>Methods: </strong>An online questionnaire was presented to people with T1D in France on a global online participant community platform. The questionnaire was developed by a scientific committee including paediatric and adult diabetologists and refined by a group of participants. Thematic qualitative analysis was performed on the responses.</p><p><strong>Results: </strong>A total of 104 respondents were included in the survey (mean age 24.4 years [95% CI 23.8-25.0]; 61.5% female). The mean age at the time of transition was 18.4 years (95% CI 17.8-18.9), and 56% of respondents had their first adult diabetology follow-up in the same institution. During TPA, of the 76 participants who experienced personal issues, 74% experienced at least one issue with their diabetes management in the months following the transition. In the following months, 61% experienced new or unexpected problems in monitoring their diabetes after transition and 44% reported unusual glycaemic imbalances, including hypoglycaemia (8%) and hyperglycaemia (9%) requiring hospitalisation. Presence of personal issues during TPA was significantly associated with occurrence of problems with diabetes management or glycaemic imbalance. Three factors identified for a successful transition were (i) early meeting with the 'adult' diabetes care team, (ii) letting the participants choose the right age to leave paediatric clinic and (iii) having good diabetes control at the beginning of the TPA process.</p><p><strong>Conclusion: </strong>Most young adults with T1D report experiencing issues around TPA with significant consequences on their disease management. Hence, it is necessary to identify these issues to better support them and improve diabetes management during this phase.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11411039/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141912195","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":"Insights into Knowledge and Attitudes About Autoantibody Screening from People Affected by Type 1 Diabetes: A Brief Report.","authors":"Caitlin S Kelly, Wendy A Wolf, Emilee M Cornelius, Megan E Peter, Katherine S Chapman, Jessica L Dunne","doi":"10.1007/s13300-024-01637-z","DOIUrl":"10.1007/s13300-024-01637-z","url":null,"abstract":"<p><strong>Introduction: </strong>Screening for islet-specific autoantibodies can identify individuals at risk for type 1 diabetes (T1D). Despite calls for increased nationwide autoantibody screening efforts, it is unclear how many individuals have participated in screening among people who may benefit from it. Moreover, knowledge and perceptions of autoantibody screening in real-world samples are not well understood.</p><p><strong>Methods: </strong>We surveyed a sample of individuals (aged 18+ years old) from T1D Exchange Registry with a personal or family history of T1D to assess their self-reported T1D autoantibody knowledge, experiences, and attitudes. Participants belonged to one of three groups: adults with T1D who had a biological child without T1D or future plans for a child (PWD); parents without T1D who had a biological child with T1D and one or more biological children without T1D (Caregivers); and first-degree adult children or siblings to a person with T1D (Relatives). Descriptive analyses (means, standard deviations, frequencies) are presented by participant groups.</p><p><strong>Results: </strong>A total of 510 participants enrolled in the study. Across groups, participants reported feeling a little to somewhat knowledgeable about autoantibody screening and positive perceptions of autoantibody screening in general. However, few participants had screened their child without T1D (PWDs, 21.94%; Caregivers, 46.30%) or themselves (Relatives, 19.23%). Among those who had screened, participants reported generally positive experiences. Among those who had not screened, many participants were \"undecided\" about autoantibody screening (PWD, 38.46%; Caregivers, 40.52%; Relatives, 44.44%). Influences reported for participants' decisions to screen, not screen, or their current indecision differed by group: PWDs (21.70%) and Caregivers (26.87%) most often reported self-initiated research as an influence and Relatives reported they had not previously considered screening (48.28%).</p><p><strong>Conclusion: </strong>Results highlight the need for more accessible information about screening, including real experiences from those who have screened.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11410738/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142072327","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":"Targeting Autophagy: A Promising Therapeutic Strategy for Diabetes Mellitus and Diabetic Nephropathy.","authors":"Qi-Rui Li, Hui-Ying Xu, Rui-Ting Ma, Yuan-Yuan Ma, Mei-Juan Chen","doi":"10.1007/s13300-024-01641-3","DOIUrl":"10.1007/s13300-024-01641-3","url":null,"abstract":"<p><p>Diabetes mellitus (DM) significantly impairs patients' quality of life, primarily because of its complications, which are the leading cause of mortality among individuals with the disease. Autophagy has emerged as a key process closely associated with DM, including its complications such as diabetic nephropathy (DN). DN is a major complication of DM, contributing significantly to chronic kidney disease and renal failure. The intricate connection between autophagy and DM, including DN, highlights the potential for new therapeutic targets. This review examines the interplay between autophagy and these conditions, aiming to uncover novel approaches to treatment and enhance our understanding of their underlying pathophysiology. It also explores the role of autophagy in maintaining renal homeostasis and its involvement in the development and progression of DM and DN. Furthermore, the review discusses natural compounds that may alleviate these conditions by modulating autophagy.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11410753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016691","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 Association of HbA_1c Variability with 12 Week and 12 Month Outcomes on Diabetes Related Foot Ulcer Healing.","authors":"Georgia Thomason, Catherine Gooday, Ian Nunney, Ketan Dhatariya","doi":"10.1007/s13300-024-01640-4","DOIUrl":"10.1007/s13300-024-01640-4","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to determine the relationship between HbA_1c variability and foot ulcer healing at 12 weeks and 12 months.</p><p><strong>Methods: </strong>Using National Diabetic Foot Care Audit (NDFA) and hospital records, demographics, baseline ulcer characteristics and healing outcomes for subjects presenting with a foot ulcer between 2017-2022 were collected at 12 weeks and 12 months. Subjects had diabetes duration > 3 years and ≥ 3 HbA_1c recordings in the 5 years prior to presentation.</p><p><strong>Results: </strong>At 12 weeks, factors associated with an active ulcer were presence on hind foot (adjusted odds ratios) (2.1 [95% CI 1.3-3.7]), ischaemia (2.1 [95% CI:1.4-3.2]), area > 1 cm² (2.7 [95% CI:1.7-4.2]) and diabetes duration > 24 years vs 3-10 (AOR 2.0 [95% CI 1.2-3.5]). After adjustment, HbA_1c variability 6-10 mmol/mol and > 14.5 mmol/mol had AOR of 1.76 (95% CI 1.1-2.8; p = 0.0192) and 1.5 (95% CI 0.9-2.6; p = 0.1148) of an active ulcer at 12 weeks vs variability < 6 mmol/mol. At 12 months, ischaemia (AOR 2.4 [95% CI 1.5-3.8]) and diabetes duration > 24 years vs 3-10 years (AOR 3.3 [95% CI 1.7-6.4] were significant factors. HbA_1c variability was not significant at 12 months.</p><p><strong>Conclusion: </strong>In keeping with the national NDFA data, in our cohort ulcer characteristics, but not HbA_1c variability, were the key factors associated with ulcer healing at 12 weeks and 12 months.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11411040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995486","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":"12-Month Time in Tight Range Improvement with Advanced Hybrid-Closed Loop System in Adults with Type 1 Diabetes.","authors":"Laura Nigi, Maria De Los Angeles Simon Batzibal, Dorica Cataldo, Francesco Dotta","doi":"10.1007/s13300-024-01656-w","DOIUrl":"https://doi.org/10.1007/s13300-024-01656-w","url":null,"abstract":"<p><strong>Introduction: </strong>Time in tight range (TITR) is an emerging and valuable metric for assessing normoglycemia. The latest advancement in automated insulin delivery (AID) systems, the advanced hybrid closed-loop (AHCL) systems, are particularly noteworthy for managing type 1 diabetes (T1D) and enhancing glycemic control.</p><p><strong>Methods: </strong>In a real-world clinical setting, we carried out a retrospective evaluation of TITR in 42 adult subjects with T1D using the AHCL Minimed™ 780G system over a 12-month period.</p><p><strong>Results: </strong>Within just 14 days of activating the automatic mode, the AHCL Minimed™ 780G system showed rapid improvement in TITR, and in the other continuous glucose monitoring (CGM) metrics. This improvement persisted over 12 months, achieving the proposed 45-50% range for effective glycemic control.</p><p><strong>Conclusion: </strong>The AHCL Minimed™ 780G system significantly enhances TITR, demonstrating continuous improvement throughout a 12-month follow-up period.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343443","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":"Rationale and Design of the Study to Investigate the Metabolic Action of Imeglimin on Patients with Type 2 Diabetes Mellitus (SISIMAI).","authors":"Tsubasa Tajima, Hideyoshi Kaga, Naoaki Ito, Toshiki Kogai, Hitoshi Naito, Saori Kakehi, Satoshi Kadowaki, Yuya Nishida, Ryuzo Kawamori, Yoshifumi Tamura, Hirotaka Watada","doi":"10.1007/s13300-024-01655-x","DOIUrl":"https://doi.org/10.1007/s13300-024-01655-x","url":null,"abstract":"<p><strong>Introduction: </strong>Imeglimin is a first-in-class, novel, oral glucose-lowering agent for the treatment of type 2 diabetes mellitus. The efficacy and safety of imeglimin as an antidiabetic agent have been investigated in clinical trials. However, its metabolic effects in humans have not yet been fully elucidated.</p><p><strong>Methods: </strong>The Study to InveStIgate the Metabolic Action of Imeglimin on patients with type 2 diabetes mellitus (SISIMAI) is a single-arm intervention study. In this study, we have recruited 25 patients with type 2 diabetes to receive 2000 mg/day imeglimin for 20 weeks. We perform a 75-g oral glucose tolerance test (OGTT) with double-glucose tracers, a two-step hyperinsulinemic-euglycemic clamp with glucose tracer, ectopic fat measurement by proton magnetic resonance spectroscopy, visceral/subcutaneous fat area measurement by magnetic resonance imaging, muscle biopsy, and evaluation of fitness level by cycle ergometer before and after imeglimin administration.</p><p><strong>Planned outcomes: </strong>The primary outcome is the change in area under the curve of glucose levels during the OGTT after 20 weeks of imeglimin treatment. We also calculate the endogenous glucose production, rate of oral glucose appearance, and rate of glucose disappearance from the data during the 75-g OGTT and compare them between pre- and post-treatment. Additionally, we will compare other parameters, such as the changes in tissue-specific insulin sensitivity, ectopic fat accumulation, visceral/subcutaneous fat area accumulation, and fitness level between each point. This is the first study to investigate the organ-specific metabolic action of imeglimin in patients with type 2 diabetes mellitus using the 75-g OGTT with the double tracer method. The results of this study are expected to provide useful information for drug selection based on the pathophysiology of individual patients with type 2 diabetes mellitus.</p><p><strong>Trial registration: </strong>jRCTs031210600.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343459","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":"Insulin Delivery Technology for Treatment of Infants with Neonatal Diabetes Mellitus: A Systematic Review","authors":"Raffaella Panza, Valentina Cattivera, Jacopo Colella, Maria Elisabetta Baldassarre, Manuela Capozza, Luca Zagaroli, Maria Laura Iezzi, Nicola Laforgia, Maurizio Delvecchio","doi":"10.1007/s13300-024-01653-z","DOIUrl":"https://doi.org/10.1007/s13300-024-01653-z","url":null,"abstract":"<p>Neonatal diabetes mellitus is a rare disorder of glucose metabolism with onset within the first 6 months of life. The initial treatment is based on insulin infusion. The technologies for diabetes treatment can be very helpful, even if guidelines are still lacking. The current study aimed to provide a comprehensive review of the literature about the safety and efficacy of insulin treatment with technology for diabetes to support clinicians in the management of infants with neonatal diabetes mellitus. A total of 22 papers were included, most of them case reports or case series. The first infants with neonatal diabetes mellitus treated with insulin pumps were described nearly two decades ago. Over the years, continuous glucose monitoring systems were added to treat these individuals, allowing for a better customization of insulin administration. Insulin was diluted in some cases to further minimize the doses. Improvement in technology for diabetes prompted clinicians to use new devices and algorithms for insulin delivery in infants with neonatal diabetes as well. These systems are safe and effective, may shorten hospital stay, and help clinicians weaning insulin during the remission phase in the transient forms or switching from insulin to sulfonylurea when suggested by the molecular diagnosis. New technologies for insulin delivery in infants with neonatal diabetes can be used safely and closed-loop algorithms can work properly in these situations, optimizing blood glucose control.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142251862","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":"Efficacy and Safety of Pioglitazone/Metformin Fixed-Dose Combination Versus Uptitrated Metformin in Patients with Type 2 Diabetes without Adequate Glycemic Control: A Randomized Clinical Trial","authors":"Li-xin Guo, Lian-wei Wang, De-zeng Tian, Feng-mei Xu, Wei Huang, Xiao-hong Wu, Wei Zhu, Jun-Qiu Chen, Xin Zheng, Hai-Yan Zhou, Hong-Mei Li, Zhong-Chen He, Wen-Bo Wang, Li-Zhen Ma, Jun-Ting Duan","doi":"10.1007/s13300-024-01638-y","DOIUrl":"https://doi.org/10.1007/s13300-024-01638-y","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>We aim to evaluate the efficacy and safety of pioglitazone/metformin fixed-dose combination (FDC) versus uptitrated metformin in patients with type 2 diabetes mellitus (T2DM) without adequate glycemic control.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>A total of 304 patients were recruited from 15 hospitals in China and randomly assigned (1:1) to the test group (pioglitazone/metformin FDC, 15/500 mg) or the control group (uptitrated metformin, 2000–2500 mg/day). The primary endpoint was the proportion of patients with glycated hemoglobin A1c (HbA1c) ≤ 6.5% and ≤ 7.0% at week 16. The secondary outcomes included the change from baseline in glucose, serum lipids, and liver function. Full analysis set (FAS) and per-protocol set (PPS) were used for analyses.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>In the test group, 103 (69.59%) patients reached HbA1c ≤ 7.0% (FAS, <i>P</i> = 0.009), with 68 (45.95%) patients achieved HbA1c ≤ 6.5 (FAS, <i>P</i> = 0.043). More reduction in HbA1c, homeostatic model assessment for insulin resistance, and diastolic pressure was found. Bodyweight, body mass index, and high-density lipoprotein cholesterol increased markedly. The changes of triglycerides, alanine transaminase, aspartate aminotransferase, and high-sensitivity C-reactive protein decreased noticeably. There were no significant differences in rates of adverse events between the two groups.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Pioglitazone/metformin FDC was superior to uptitrated metformin among patients with T2DM without adequate glycemic control.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration Number</h3><p>This trial is registered with the Chinese Clinical Trial Registry (ChiCTR1900028606).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142251861","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":"Real-Life Effectiveness of iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) in People with Type 2 Diabetes (T2D) According to Baseline HbA1c and BMI","authors":"Janos T. Kis, Jochen Seufert, Martin Haluzík, Mireille Bonnemaire, Carine Vera, Mathilde Tournay, Nick Freemantle, Cristian Guja","doi":"10.1007/s13300-024-01644-0","DOIUrl":"https://doi.org/10.1007/s13300-024-01644-0","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>This study aimed to evaluate the effect of baseline body mass index (BMI) and glycated hemoglobin (HbA1c) on the effectiveness and safety of initiating iGlarLixi (insulin glargine 100 U/ml and lixisenatide) in people with type 2 diabetes (T2D) in routine clinical practice.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We pooled patient-level data from 1406 people with inadequately controlled T2D, initiating a 24-week iGlarLixi treatment. Analysis sets were based on baseline BMI and HbA1c. In the BMI set, 894 (64%) people had a BMI ≥ 30 kg/m² and 510 (36%) a BMI &lt; 30 kg/m²; in the HbA1c set, 615 (44%) people had an HbA1c &gt;9%, 491 (35%) between 8 and 9%, and 298 (21%) &lt; 8%.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>After initiating iGlarLixi, HbA1c decreased in all participants, with the greatest least-squares mean reduction at 2.15% from baseline to week 24 in those with baseline HbA1c &gt; 9% (using a mixed model for repeated measures). Overall, mean ± standard deviation body weight decreased by 1.9 ± 4.8 kg, with the most prominent loss of 2.6 ± 4.9 kg recorded in people presenting with obesity. Reported hypoglycemia rates were low across all groups.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Initiation of iGlarLixi in people with uncontrolled T2D is effective and safe in clinical practice, across different baseline HbA1c and BMI categories.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142251859","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}