Diabetes Therapy最新文献

{"title":"Intentional Insulin Overdose and Depression in Subjects with and Without Diabetes Mellitus: A Commentary.","authors":"Evanthia Gouveri, Aikaterini Gkouveri, Djordje S Popovic, Dimitrios Papazoglou, Nikolaos Papanas","doi":"10.1007/s13300-024-01623-5","DOIUrl":"10.1007/s13300-024-01623-5","url":null,"abstract":"<p><p>Insulin is an essential medication for people with type 1 diabetes mellitus and for some people with type 2 diabetes. Interestingly, insulin abuse has been reported as a mode of suicide, not only among people with diabetes, but also among their relatives, and among medical and paramedical personnel who have access to insulin. The aim of the present commentary was to raise awareness of potential depression-related intentional insulin overdose and its complications, as well as of the diagnosis and treatment of this entity. Insulin overdose may lead to severe and prolonged hypoglycemia, hypoglycemic coma, and death. Moreover, hypokalemia, hypomagnesemia, hypophosphatemia, and elevated liver enzymes are common. Insulin overdose should be suspected among people with diabetes in case of unexplained prolonged hypoglycemia and among people without diabetes who exhibit hypoglycemia and may have access to diabetic medications. The ratio of insulin to C-peptide helps distinguish exogenous insulin administration from endogenous secretion. The cornerstone of therapy is prompt administration of concentrated glucose infusions for days with simultaneous oral intake, when possible, and intense glucose monitoring to prevent hypoglycemia. Moreover, monitoring of serum electrolyte levels is recommended. Finally, psychiatric evaluation aiming at early identification of depression and suicidality is of paramount importance.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330432/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PIONEER REAL Sweden: A Multicentre, Prospective, Real-World Observational Study of Oral Semaglutide Use in Adults with Type 2 Diabetes in Swedish Clinical Practice.","authors":"Sergiu-Bogdan Catrina, Hanan Amadid, Uffe C Braae, Jonatan Dereke, Neda Rajamand Ekberg, Boris Klanger, Stefan Jansson","doi":"10.1007/s13300-024-01614-6","DOIUrl":"10.1007/s13300-024-01614-6","url":null,"abstract":"<p><strong>Introduction: </strong>The study was designed to assess outcomes with once-daily oral semaglutide in adults with type 2 diabetes (T2D) naïve to injectable glucose-lowering agents, in Swedish clinical practice.</p><p><strong>Methods: </strong>In this non-interventional, multicentre study, participants initiated oral semaglutide and were followed for 34-44 weeks. The primary endpoint was glycated haemoglobin (HbA_1c) change from baseline to end of study (EOS). Secondary endpoints included body weight (BW) change from baseline to EOS, proportion of participants achieving HbA_1c < 7%, and proportion achieving both a HbA_1c reduction ≥ 1% and BW reduction of ≥ 3% or ≥ 5%, at EOS. Participants completed Diabetes Treatment Satisfaction Questionnaires (DTSQ status/change) and a dosing conditions questionnaire.</p><p><strong>Results: </strong>A total of 187 participants (mean age 62.5 years) initiated oral semaglutide. Baseline mean HbA_1c and BW were 7.8% (n = 177) and 96.9 kg (n = 165), respectively. Estimated mean changes in HbA_1c and BW were - 0.88%-points (95% confidence interval [CI] - 1.01 to - 0.75; P < 0.0001) and - 4.72% (95% CI - 5.58 to - 3.86; P < 0.0001), respectively. At EOS, 64.6% of participants had HbA_1c < 7%, and 22.9% achieved HbA_1c reduction of ≥ 1% and BW reduction of ≥ 5%. DTSQ status and change scores improved by 1.44 (P = 0.0260) and 12.3 points (P < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 86.4% of participants. Most common adverse events (AEs) were gastrointestinal disorders; nine participants (4.8%) had serious AEs; one (0.5%) experienced severe hypoglycaemia.</p><p><strong>Conclusion: </strong>In this real-world study population, we observed significant reductions in HbA_1c and BW in people living with T2D when prescribed semaglutide tablets as part of routine clinical practice in Sweden, with improved treatment satisfaction among participants and no new safety concerns.</p><p><strong>Trial registration: </strong>NCT04601753.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330427/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757743","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":"Efficacy and Safety of Escalating the Dose of Oral Semaglutide from 7 to 14 mg: A Single-Center, Retrospective Observational Study.","authors":"Genki Sato, Hiroshi Uchino, Takahisa Hirose","doi":"10.1007/s13300-024-01631-5","DOIUrl":"10.1007/s13300-024-01631-5","url":null,"abstract":"<p><strong>Introduction: </strong>The efficacy and safety of oral semaglutide, the first glucagon-like peptide 1 receptor agonist available in tablet form for the treatment of type 2 diabetes, were established in the phase 3a PIONEER program. However, evidence regarding the titration of oral semaglutide in real-world clinical settings remains insufficient. This study aimed to elucidate the therapeutic advantages of escalating the dose of oral semaglutide from 7 to 14 mg through clinical data analysis.</p><p><strong>Methods: </strong>This retrospective observational study was conducted at a single center in Japan, focusing on adults with type 2 diabetes who were initiated on 14 mg oral semaglutide. The primary endpoint was the alteration in HbA1c levels 24 weeks after the initial prescription of 14 mg oral semaglutide. Secondary endpoints included changes in metabolic parameters and the incidence of adverse events.</p><p><strong>Results: </strong>Data from 66 patients who met the inclusion criteria were analyzed. The mean change in HbA1c levels from baseline to 24 weeks following dose escalation was - 0.5 ± 0.8% [from 7.4 ± 1.0% at baseline to 7.0 ± 0.9% at 24 weeks (p < 0.01)]. Moreover, a significant reduction in body weight of - 2.0 ± 4.4 kg was observed at 24 weeks [from 90.0 ± 20.5 kg at baseline to 88.2 ± 21.4 kg at 24 weeks (p < 0.01)], with 41% of patients achieving at least a 3% reduction compared to baseline. Gastrointestinal disorders emerged as the most prevalent adverse event (10.6%), particularly nausea (7.6%), although predominantly of mild or moderate severity, with no instances of serious adverse events necessitating drug discontinuation.</p><p><strong>Conclusion: </strong>Escalating the dose of oral semaglutide to 14 mg could be an effective approach for enhancing glycemic control and managing body weight in individuals with type 2 diabetes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330422/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897056","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":"Modern Management of Cardiometabolic Continuum: From Overweight/Obesity to Prediabetes/Type 2 Diabetes Mellitus. Recommendations from the Eastern and Southern Europe Diabetes and Obesity Expert Group.","authors":"Andrej Janez, Emir Muzurovic, Pawel Bogdanski, Leszek Czupryniak, Lubomira Fabryova, Zlatko Fras, Cristian Guja, Martin Haluzik, Peter Kempler, Nebojsa Lalic, Dana Mullerova, Anca Pantea Stoian, Nikolaos Papanas, Dario Rahelic, José Silva-Nunes, Tsvetalina Tankova, Volkan Yumuk, Manfredi Rizzo","doi":"10.1007/s13300-024-01615-5","DOIUrl":"10.1007/s13300-024-01615-5","url":null,"abstract":"<p><p>The increasing global incidence of obesity and type 2 diabetes mellitus (T2D) underscores the urgency of addressing these interconnected health challenges. Obesity enhances genetic and environmental influences on T2D, being not only a primary risk factor but also exacerbating its severity. The complex mechanisms linking obesity and T2D involve adiposity-driven changes in β-cell function, adipose tissue functioning, and multi-organ insulin resistance (IR). Early detection and tailored treatment of T2D and obesity are crucial to mitigate future complications. Moreover, personalized and early intensified therapy considering the presence of comorbidities can delay disease progression and diminish the risk of cardiorenal complications. Employing combination therapies and embracing a disease-modifying strategy are paramount. Clinical trials provide evidence confirming the efficacy and safety of glucagon-like peptide 1 receptor agonists (GLP-1 RAs). Their use is associated with substantial and durable body weight reduction, exceeding 15%, and improved glucose control which further translate into T2D prevention, possible disease remission, and improvement of cardiometabolic risk factors and associated complications. Therefore, on the basis of clinical experience and current evidence, the Eastern and Southern Europe Diabetes and Obesity Expert Group recommends a personalized, polymodal approach (comprising GLP-1 RAs) tailored to individual patient's disease phenotype to optimize diabetes and obesity therapy. We also expect that the increasing availability of dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists will significantly contribute to the modern management of the cardiometabolic continuum.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141579201","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":"Tirzepatide: A Double Agonist for Various People Living with Type 2 Diabetes.","authors":"Felice Strollo, Giuseppina Guarino, Ersilia Satta, Sandro Gentile","doi":"10.1007/s13300-024-01624-4","DOIUrl":"10.1007/s13300-024-01624-4","url":null,"abstract":"<p><p>Tirzepatide is the first ever once-weekly, injectable gastric inhibitory peptide/glucagon-like peptide 1 (GIP/GLP-1) dual agonist approved by the European Medicines Agency for type 2 diabetes. The efficacy and safety of tirzepatide have been evaluated in five global, randomized, double-blind or open-label, phase 3 studies which enrolled over 7000 people living with type 2 diabetes, across various stages of disease and with different characteristics at baseline. In this short commentary we report the salient data of the most recent trials on tirzepatide and GLP-1 receptor agonists from a clinical point of view, with the aim of highlighting similarities and mutual differences.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859328","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":"Epidemiology and Burden of Peripheral Artery Disease in People With Type 2 Diabetes: A Systematic Literature Review.","authors":"Subodh Verma, Lawrence A Leiter, Kamal K Mangla, Nick F Nielsen, Yasemin Hansen, Marc P Bonaca","doi":"10.1007/s13300-024-01606-6","DOIUrl":"10.1007/s13300-024-01606-6","url":null,"abstract":"<p><p>Type 2 diabetes (T2D) and lower-extremity peripheral artery disease (PAD) are growing global health problems associated with considerable cardiovascular (CV) and limb-related morbidity and mortality, poor quality of life and high healthcare resource use and costs. Diabetes is a well-known risk factor for PAD, and the occurrence of PAD in people with T2D further increases the risk of long-term complications. As the available evidence is primarily focused on the overall PAD population, we undertook a systematic review to describe the burden of comorbid PAD in people with T2D. The MEDLINE, Embase and Cochrane Library databases were searched for studies including people with T2D and comorbid PAD published from 2012 to November 2021, with no restriction on PAD definition, study design or country. Hand searching of conference proceedings, reference lists of included publications and relevant identified reviews and global burden of disease reports complemented the searches. We identified 86 eligible studies, mostly observational and conducted in Asia and Europe, presenting data on the epidemiology (n = 62) and on the clinical (n = 29), humanistic (n = 12) and economic burden (n = 12) of PAD in people with T2D. The most common definition of PAD relied on ankle-brachial index values ≤ 0.9 (alone or with other parameters). Incidence and prevalence varied substantially across studies; nonetheless, four large multinational randomised controlled trials found that 12.5%-22% of people with T2D had comorbid PAD. The presence of PAD in people with T2D was a major cause of lower-limb and CV complications and of all-cause and CV mortality. Overall, PAD was associated with poor quality of life, and with substantial healthcare resource use and costs. To our knowledge, this systematic review provides the most comprehensive overview of the evidence on the burden of PAD in people with T2D to date. In this population, there is an urgent unmet need for disease-modifying agents to improve outcomes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330435/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632900","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":"Summary of Research: Cardiovascular and Kidney Outcomes with Finerenone in Patients with Type 2 Diabetes and Chronic Kidney Disease-The FIDELITY Pooled Analysis.","authors":"Karin Humle, Boris Klanger, Peter Kolkhof, Sylvia E Rosas, Peter Rossing, Eugene Wright, Nichole Jefferson","doi":"10.1007/s13300-024-01591-w","DOIUrl":"10.1007/s13300-024-01591-w","url":null,"abstract":"<p><p>People living with type 2 diabetes (T2D) and chronic kidney disease (CKD) are at risk of CKD progression and kidney failure. This is a summary of the FIDELITY pooled analysis where two clinical trials (FIDELIO-DKD and FIGARO-DKD) were performed to investigate the safety and efficacy of finerenone in people with T2D and CKD. The data from these two studies were combined and analyzed and it was found that those who took finerenone on top of standard-of-care medicine had a 14% reduced risk of having a cardiovascular event and 23% reduced risk of having a kidney event versus those who took placebo. Those who took finerenone were also more likely to have high blood potassium, but this was mostly manageable.A graphical abstract and translations of all content (Chinese, Japanese, German, Spanish, Brazilian-Portuguese, French) are available for this article.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330426/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141723285","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":"Impact of Initial Treatment Policies on Long-term Complications and Costs in Japanese Patients with Type 2 Diabetes: A Real-World Database Study.","authors":"Hiroshi Yoshihara, Tohru Tonoike, Hiromitsu Ohno, Susumu Nishiuchi, Ataru Igarashi","doi":"10.1007/s13300-024-01611-9","DOIUrl":"10.1007/s13300-024-01611-9","url":null,"abstract":"<p><strong>Introduction: </strong>Type 2 diabetes (T2D) represents a remarkable disease burden in Japan, and the cost-effectiveness of pharmacotherapy is an important consideration. In this study, we compared the long-term effects of the type of initial medication, as well as the initial frequency of clinic visits, on the occurrence of T2D-related complications. Additionally, we compared the medical costs associated with each treatment pattern.</p><p><strong>Methods: </strong>We analyzed electronic health record data collected from multiple primary care clinics in Japan. Patients were selected based on being primarily prescribed either biguanides (BG) or DPP-4 inhibitors (DPP-4i) during a 3-month baseline period, both of which are commonly used as first-choice medications in Japan. We then followed the onset of T2D-related complications and conducted survival analyses. Additionally, we calculated the accumulated medical costs up to the onset of an event or loss to follow-up, and summarized the annual costs per patient for each treatment pattern.</p><p><strong>Results: </strong>A total of 416 Japanese patients with T2D who initiated treatment between January 2015 and September 2021 were included. The median follow-up period was 2.69 years. The survival analysis showed that the use of DPP-4is and frequent visits from the beginning of treatment did not offer a benefit in suppressing the onset of complications later on. On the other hand, it was found that the annual medical costs for the group using DPP-4i with frequent visits were about 1.9 times higher than for the group using BGs with less frequent visits.</p><p><strong>Conclusions: </strong>The results suggest that for Japanese patients with T2D, the use of BGs along with relatively long follow-up intervals in the beginning of treatment can remarkably reduce medical costs while providing a level of complication suppression equivalent to that of the use of DPP-4is or frequent visits.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141445825","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 of Urogenital Bacterial Infection with Sodium-Glucose Cotransporter-2 Inhibitors: A Retrospective Cohort Study Using a Claims Database.","authors":"Takanori Imai, Naoto Kato, Naoki Kanda, Hideki Hashimoto, Hayato Yamana, Shuji Hatakeyama","doi":"10.1007/s13300-024-01613-7","DOIUrl":"10.1007/s13300-024-01613-7","url":null,"abstract":"<p><strong>Introduction: </strong>The association between sodium-glucose cotransporter-2 (SGLT2) inhibitors and the risk of urogenital infections remains controversial. This study aimed to investigate the association between SGLT2 inhibitors and the incidence of perineal soft tissue infections, including Fournier's gangrene (FG), genital bacterial infections, and urinary tract infections (UTIs), using administrative claims data in Japan.</p><p><strong>Methods: </strong>In this retrospective cohort study, we utilized the JMDC Claims Database. The study included patients aged 18 years or older diagnosed with type 2 diabetes mellitus, identified by a diagnostic code, who received new prescriptions for SGLT2 inhibitors or dipeptidyl peptidase 4 (DPP-4) inhibitors between April 2014 and August 2020. Using one-to-one propensity score (PS) matching, we compared the incidence of perineal soft tissue infections, including FG, genital bacterial infection, and UTIs between groups treated with SGLT2 and DPP-4 inhibitors. Hazard ratios (HR) and their 95% confidence intervals (CI) were estimated using the Cox proportional hazards model.</p><p><strong>Results: </strong>We identified 34,897 patients in the SGLT2 inhibitor group and 135,311 patients in the DPP-4 inhibitor group. After one-to-one PS matching, 31,665 pairs were generated. The mean age of the patients was 51 years, with approximately 70% being male. The use of SGLT2 inhibitors was associated with a decreased risk of UTI (HR 0.90, 95% CI 0.83-0.98) and an increased risk of genital bacterial infection (HR 1.23, 95% CI 1.03-1.46) compared to DPP-4 inhibitors. However, no significant association was observed with perineal soft tissue infection (HR 1.05, 95% CI 0.61-1.81).</p><p><strong>Conclusions: </strong>SGLT2 inhibitors were associated with a reduced risk of UTI and an increased risk of genital bacterial infection. They showed no significant association with perineal soft tissue infection when compared to DPP-4 inhibitors. Future research should explore broader demographics, focusing on the elderly and achieving gender balance, to gain a comprehensive understanding of infection risks.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141491263","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":"Responses to Basal Insulin Glargine (300 U/mL and 100 U/mL) with or Without Pre-prandial Insulin in Pre-treated Subphenotypes of Type 2 Diabetes: Insights from a Post Hoc Analysis.","authors":"Wolfgang Landgraf, David R Owens, Brian M Frier, Geremia B Bolli","doi":"10.1007/s13300-024-01608-4","DOIUrl":"10.1007/s13300-024-01608-4","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to evaluate glycemic outcomes in subphenotypes of type 2 diabetes (T2D) with HbA1c > 7.0%, previously on basal insulin (pre-BI) alone (≥ 42 U/day) or on basal-bolus therapy (pre-BB), and who were switched to either basal insulin glargine 300 U/mL (IGlar-300) or 100 U/mL (IGlar-100), with or without pre-prandial insulin.</p><p><strong>Methods: </strong>Participants from EDITION 2 (pre-BI, n = 785), and EDITION 1 (pre-BB, n = 792) trials were assigned retrospectively to subphenotypes of T2D: severe insulin deficient diabetes (SIDD), mild age-related diabetes (MARD), mild obesity diabetes (MOD), and severe insulin resistant diabetes (SIRD). Key efficacy and safety parameters were analyzed at baseline, and after 26 weeks, for IGlar-300 and IGlar-100 pooled groups according to subphenotypes. Outcomes were also compared with insulin-naïve subphenotypes on oral antihyperglycemic drugs (OADs) from the EDITION 3 trial (pre-OAD, n = 858).</p><p><strong>Results: </strong>Pre-BI and pre-BB treated subphenotypes with SIDD had a higher mean HbA1c (8.9% and 9.1%) at baseline compared to those of MARD (7.7% and 7.8%) and MOD (8.1% and 8.2%) and after 26 weeks remained above target HbA1c (7.7% and 8.0%) despite mean glargine doses of 0.7 to 1.0 U/kg/day and pre-prandial insulin use in the pre-BB SIDD subgroup. Pre-BB treated individuals with MARD and MOD achieved lower HbA1c levels (6.9% and 7.2%) than the pre-BI groups (7.3% and 7.5%) despite similar mean FPG levels (123-130 mg/dL). Only 19-22% of participants with SIDD achieved HbA1c < 7.0% compared to 33-51% with MARD and MOD, respectively. Pre-BI and pre-BB treated subphenotypes experienced more hypoglycemia than pre-OAD treated subphenotypes.</p><p><strong>Conclusion: </strong>Individuals with T2D assigned post hoc to the SIDD subphenotype achieved suboptimal glycemic control with glargine regimens including basal-bolus therapy, alerting clinicians to improve further diabetes treatment, particularly post-prandial glycemic control, in individuals with SIDD.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263304/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327379","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}