Stehen wir am Anfang vom Ende der Adipositas- und der Typ-2-Diabetes-Epidemie, da die Wirksamkeit und Sicherheit der Inkretin-Rezeptoragonisten alle bisherigen therapeutischen Ansätze bei weitem übertreffen, noch effektivere Substanzen in der pipeline sind und auch die Versorgungsprobleme gelöst werden können? Eine spannende Frage, die Patienten, Ärzte und Diabetesforschende gleichermaßen betrifft. In einigen Jahren wird man feststellen können, ob wirklich ein neues Zeitalter in der Adipositas- und Diabetestherapie mit der Zulassung dieser Substanzen begonnen hat.

Introduction and Objective: No head-to-head studies compare daily Gla-300 vs weekly insulin Icodec. This analysis compared these two basal insulins in insulin-naïve PWT2D on OADs. Methods: MEDLINE®, Embase, and CENTRAL databases were searched on July 3, 2025 for RCTs evaluating once-daily Gla-300 or once-weekly Icodec in insulin-naïve PWT2D. Treatment effects at ~6 months were estimated using Bayesian and frequentist models. Results: Five RCTs (n=3,246; Gla-300 n=2,411; Icodec n=835) with comparable baseline characteristics were included (Table). Gla-300 was consistently associated with lower risk and event rates of 24-hour hypoglycemia vs Icodec, including level 1, level 2, and combined level 2/3 hypoglycemia. No significant differences were observed for level 3 hypoglycemia. Glycemic outcomes were generally similar, with no significant differences in HbA1c or body weight change. Gla-300 patients were less likely to attain HbA1c <7%, and FPG reduction was smaller vs Icodec; final daily insulin dose (U/day) was higher, with no difference per U/kg. Non-hypoglycemia safety outcomes were comparable. Frequentist analyses were broadly concordant (data not shown). Conclusion: In insulin-naïve PWT2D on OADs, Gla-300 was associated with lower level 1 and 2 hypoglycemia risk vs Icodec, with broadly comparable glycemic measures and overall safety at ~6 months. Disclosure R. Ritzel: Other - Advisory board/speaker bureau/honoraria; Current; Novo Nordisk, Sanofi, Merck & Co., Inc., AstraZeneca, Lilly, Novartis Pharmaceuticals Corporation, Pfizer Inc. F. Gomez-Peralta: Research Support; Ended; Abbott Diabetes, Novo Nordisk. Research Support; Current; Eli Lilly and Company. Speaker's Bureau; Ended; AstraZeneca. Advisory Panel; Current; Insulcloud SL, Sanofi. Speaker's Bureau; Ended; Sanofi. R. Napoli: None. A. Ratzki-Leewing: Advisory Panel; Current; Sanofi. Consultant; Current; Vertex Pharmaceuticals Incorporated, Dexcom, Inc. Research Support; Current; Sanofi. Other - Paid presentation; Ended; Abbott. Consultant; Current; Sanofi. M. N. Mabunay: Employee; Current; Sanofi. M. Szigeti: Employee; Current; Sanofi. S. Sanyal: Employee; Current; Sanofi. A. Alvarez: Employee; Current; Sanofi. V. Wan: Consultant; Current; Sanofi. F. Giorgino: Advisory Panel; Current; Abbott. Consultant; Current; Lilly, Novo Nordisk. Advisory Panel; Current; AstraZeneca, Medtronic. Research Support; Current; Roche Diabetes Care. Advisory Panel; Current; LifeScan, Sanofi. Advisory Panel; Ended; Merck Sharp & Dohme Corp. Advisory Panel; Current; Boehringer Ingelheim International GmbH. Funding This study was funded by Sanofi

Tirzepatide is recommended as a first-line injectable for people with type 2 diabetes (T2D), but there is a paucity of data on the use of basal insulin after tirzepatide in this population. This study aimed to evaluate glycemic control in people with T2D newly intensified with insulin glargine 300 U/ml (Gla-300) who had suboptimal HbA1c after treatment with tirzepatide. DELIVER-T was a retrospective analysis of the US Optum’s Clinformatics® Data Mart from January 1, 2022 to August 31, 2024. People with T2D were included if they were insulin naïve and were previously treated with tirzepatide and then intensified with Gla-300. The primary analysis (Gla-300 switch/add-on group) included all those with a HbA1c > 7.0

Aims: To evaluate treatment advancement with insulin glargine 300 U/mL (Gla-300), with or without prior glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy in type 2 diabetes (T2D). Methods: Efficacy and safety outcomes of insulin-na & iuml;ve patients intensifying with Gla-300, with/without prior GLP-1 RA therapy, were evaluated in three analyses (N = 3562): a pooled analysis of seven interventional studies, a subanalysis comparing participants who stopped GLP-1 RA therapy and initiated Gla-300 with those who received add-on Gla-300, and an expanded analysis including two observational studies. Results: Glycaemic outcomes, including HbA1c improvement and fasting plasma glucose, were similar between groups with/without prior GLP-1 RA use. HbA1c least squares mean change from baseline was - 1.7 % and 1.6 % with and without prior GLP-1 RA, respectively. Glycaemic outcomes were similar between participants who stopped GLP-1 RA therapy when initiating Gla-300 and those who received add-on Gla-300, although more participants receiving add-on Gla-300 achieved HbA1c targets. The expanded analysis yielded similar results. Incidence of hypoglycaemia was low with no clinically relevant weight changes in all analyses. Conclusions: Treatment advancement with Gla-300 in patients with T2D, with/without prior GLP-1 RA therapy, improved glycaemic outcomes with no relevant impact on weight, while maintaining a low hypoglycaemia risk.

fast die Hälfte der Teilnehmer einer aktuellen Statista-Umfrage gaben jeweils "Mehr Sport treiben" und "Gesünder ernähren" als ihre guten Vorsätze für das Jahr 2024 an.

Fragestellung Die SoliMix-Studie zeigte für iGlarLixi vs. BIAsp 30 einen besseren HbA1c mit Gewichtsvorteil und geringerem Hypoglykämierisiko bei Menschen mit Typ-2-Diabetes, die von einer basalunterstützten oralen Therapie (BOT) umgestellt wurden. In dieser explorativen Analyse wurde untersucht, ob Hypoglykämien Einfluss auf die Insulintitration und das Erreichen der Nüchternplasmaglukose-Ziele bei den beiden Therapieoptionen hatten.

das Jahr 2023 neigt sich dem Ende zu und Sie erhalten die letzte Ausgabe dieses Jahres von Diabetologie und Stoffwechsel, die noch einmal wichtige Neuigkeiten, Beiträge, Nachrichten und Diskussionsbeiträge für Sie bietet.

For older adults (>65 years) with type 2 diabetes (T2D), iGlarLixi can be a simple and effective therapeutic option. We aimed to identify factors associated with achieving target HbA1c <7% and derived Time in Range (dTIR) ≥70% in this population in response to once daily iGlarLixi. This post-hoc, pooled analysis of 4 randomized trials included 465 people advancing from oral (LixiLan-O), GLP-1 RA (LixiLan-G), or insulin (LixiLan-L; SoliMix) therapies to iGlarLixi for 26 or 30 weeks. HbA1c and dTIR responses were assessed at baseline (BL) and end of treatment (EOT) for each participant and classified as attained (<7.0% or dTIR ≥70%) or unattained (≥7.0% or <70%). dTIR was calculated from 7-point self-monitored plasma glucose profiles from the three LixiLan studies (LixiLan-O. G, and L). Potential predictive factors were analyzed by univariable and multivariable stepwise logistic regression. Overall, 60% of participants achieved HbA1c <7.0% and 87.5% achieved dTIR ≥70%. Predictors of attained HbA1c response (p<0.05) included lower BL HbA1c and lower BL insulin dose. Predictor of attained dTIR response (p<0.05) was higher BL fasting plasma glucose (FPG; Table), while sex, T2D duration, and obesity had no predictive value. To conclude, in older people with T2D treated with iGlarLixi, consideration of BL HbA1c and FPG, as well as BL insulin dose may improve achieving individualized glycemic targets. Disclosure M.Munshi: Consultant; Sanofi. R.Ritzel: Consultant; Novo Nordisk, Sanofi, Speaker's Bureau; Novo Nordisk, Sanofi, Pfizer Inc., Merck Sharp & Dohme Corp., Lilly. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. I.Hramiak: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi, Speaker's Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS), Insulet Corporation, Medtronic, Merck & Co., Inc., Bayer Inc. F.Lauand: Employee; Sanofi. L.Melas-melt: None. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. J.Rosenstock: Advisory Panel; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Intarcia Therapeutics, Inc., Hanmi Pharm. Co., Ltd., Research Support; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis, Novo Nordisk, Pfizer Inc., Sanofi, Intarcia Therapeutics, Inc. Funding Sanofi

Aim To compare the efficacy and safety of insulin glargine-300 once daily (Gla-300) with insulin degludec/aspart (IDegAsp) once daily in patients with type 2 diabetes (T2D) inadequately controlled on oral anti-diabetic drugs (OADs).Materials and methods A systematic literature review of randomized controlled trials was followed by an indirect treatment comparison of studies involving insulin naive adults, inadequately controlled [glycated haemoglobin (HbA1c) = 7.0%] on OADs, who received Gla-300 or IDegAsp once daily. Outcomes of interest were change in HbA1c, blood glucose, weight and insulin dose, as well as incidence and event rate of hypoglycaemia and other adverse events.Results Four trials with broadly similar baseline patient characteristics were included in the meta-analyses and indirect treatment comparison. At 24-28 weeks, the indirect comparison of Gla-300 to IDegAsp once daily estimated no statistically significant difference for change in HbA1c (%) from baseline [mean difference of 0.10% (95% CI: -0.20, 0.39; p = .52)]; a statistically significant mean difference of -1.31 kg (95% CI: -1.97, -0.65; p < .05) for change in body weight from baseline; statistically significant odds ratios of 0.62 (95% CI: 0.41, 0.93; p < .05) for incidence of any hypoglycaemia; and 0.47 (95% CI: 0.25, 0.87; p < .05) for incidence of anytime confirmed hypoglycaemia (plasma glucose <3.0-3.1 mmol/L). No significant differences were observed for insulin dose and adverse events.Conclusion In insulin-naive patients with T2D inadequately controlled on OADs, commencing Gla-300 shows a comparable HbA1c reduction, but with significantly less weight gain and a lower incidence of any and confirmed hypoglycaemia compared with commencing IDegAsp.

Fragestellung Indirekte Vergleiche deuten an, dass iGlarLixi bei der Typ-2-Diabetes-Behandlung ebenso wirksam sein kann wie Basalinsulin + rasch wirkendes Insulin (BI+RAI). Es gibt jedoch keine direkten Vergleiche zwischen iGlarLixi und BI+RAI-Schemata. Die SoliSimplify-Studie verglich diese Behandlungsarten anhand von Real-World-Daten aus einer US-Datenbank.

AIM:To assess the efficacy and safety of iGlarLixi in older people (≥65 years) with type 2 diabetes (T2D) advancing or switching from oral agents, a glucagon-like peptide-1 receptor agonist (GLP-1RA), or basal insulin. MATERIALS AND METHODS:The data of participants aged <65 years and ≥65 years from four LixiLan trials (LixiLan-O, LixiLan-G, LixiLan-L, SoliMix) were evaluated over 26 or 30 weeks. RESULTS:Participants aged <65/≥65 years (n = 1039/n = 497) had a mean baseline body mass index of 31.4 and 30.7 kg/m2 and glycated haemoglobin (HbA1c) concentration of 66 mmol/mol (8.2%) and 65 mmol/mol (8.1%), respectively. Least squares mean HbA1c change from baseline to end of treatment (EOT) was -14.32 mmol/mol (-1.31%) (95% confidence interval [CI] -14.97, -13.77 [-1.37%, -1.26%]) for those aged <65 years and -13.66 mmol/mol (-1.25%) (95% CI -14.54, -12.79 [-1.33%, -1.17%]) for those aged ≥65 years. At EOT, achievement of HbA1c targets was similar between the group aged <65 years and the group aged ≥65 years: <53 mmol/mol (<7%) (59.0% and 56.5%, respectively), <59 mmol/mol (<7.5%) (75.5% and 73.0%, respectively) and <64 mmol/mol (<8%) (83.8% and 84.1%, respectively). The incidence and event rate of American Diabetes Association Level 1 hypoglycaemia during the studies were also comparable between the two groups: 26.7% and 28.2% and 1.7 and 2.1 events per patient-year for the group aged <65 years and the group aged ≥65 years, respectively. A clinically relevant reduction in HbA1c (>1% from baseline for HbA1c ≥64 mmol/mol [≥8%] or ≥0.5% from baseline for HbA1c <64 mmol/mol [<8%]) without hypoglycaemia was attained by 50.0% and 47.6% of participants aged <65 years and ≥65 years, respectively. Adverse events were similar between the two age groups. CONCLUSIONS:iGlarLixi is a simple, well-tolerated, once-daily alternative for treatment advancement in older people with T2D that provides significant improvements in glycaemic control without increasing hypoglycaemia risk, thus reducing the treatment burden.

Fragestellung Intensivierung von basalunterstützter oraler Therapie (BOT) zu Therapieoptionen wie Mischinsulin kann die Blutzuckereinstellung verbessern, jedoch auf Kosten eines höheren Hypoglykämie-Risikos, einschließlich nächtlicher Hypoglykämien.

Introduction: The SoliMix trial (EudraCT: 2017-003370-13) found better HbA1c with weight benefit and lower hypoglycemia risk for iGlarLixi vs. premix BIAsp 30 in people with type 2 diabetes advancing from basal insulin plus oral antihyperglycemic drugs. This exploratory analysis investigated whether hypoglycemia influenced insulin titration and achievement of fasting plasma glucose (FPG) targets with each therapeutic option. Methods: Total insulin dose changes from baseline to Week 12 were stratified by hypoglycemia (yes/no) in each treatment arm and ADA Level 2 hypoglycemia (<54 mg/dL [<3.0 mmol/L]) event rates during Weeks 0-12 were modeled according to FPG at Week 12 (when most insulin titration occurred) . Results: Lesser insulin dose increases occurred in both treatment groups for those who experienced hypoglycemia (mean ± SD iGlarLixi: 3.9 ± 12.5 U; BIAsp 30: 11.0 ± 18.8 U) vs. those who did not (mean ± SD iGlarLixi: 11.2 ± 9.9 U; BIAsp 30: 19.4 ± 19.3 U) . While higher FPG at Week 12 correlated with greater event rates of hypoglycemia in both treatment arms, event rates were higher for BIAsp 30 than for iGlarLixi irrespective of FPG (Figure) . Conclusions: More frequent hypoglycemia with premix BIAsp 30 than with iGlarLixi may result in lower insulin doses, thus hampering insulin titration and resulting in higher FPG. Disclosure F.Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk, Consultant; Lilly Diabetes, Sanofi, Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. J.Rosenstock: Consultant; AstraZeneca, Other Relationship; Applied Therapeutics, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Hanmi Pharm. Co., Ltd., Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Research Support; Genentech, Inc., Merck & Co., Inc., Metacrine, Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., vTv Therapeutics. R.Ritzel: Consultant; Novo Nordisk, Sanofi, Speaker's Bureau; AstraZeneca, Lilly, Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi. O.Deyneli: Advisory Panel; Abbott Diabetes, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Diagnostics, Sanofi, Speaker's Bureau; Abbott, AstraZeneca, Berlin-Chemie AG, Bilim Ilaç, Boehringer Ingelheim International GmbH, Medtronic, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk, Roche Diabetes Care, Sanofi. A.Alvarez: Employee; Sanofi. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. L.Melas-melt: None. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. Funding Sanofi

die nächsten Monate werden einen großen Schritt in Richtung Normalität bringen, zumindest was die Einschränkungen, die wir in den letzten zwei Jahren durch die Coronavirus-Pandemie erlebt haben, anbelangt. Große Veranstaltungen wie der 56. Diabetes Kongress mit vielen Teilnehmern vor Ort sind wieder möglich, aber auch viele durchaus sinnvolle Praktiken der Pandemiezeit wie der Einsatz von Online-Meetings und die Teilnahme an virtuellen Veranstaltungen werden in Zukunft weiterhin genutzt werden und sind als Fortschritt zu sehen.

Fragestellung Therapeutische Ansätze zur Therapieintensivierung einer basalunterstützten oralen Therapie (BOT) bei Typ-2-Diabetespatienten erfordern eine Bewertung des Nutzens und der Risiken bei jeglicher gewählten Intervention.