Toujeo (Long-acting Recombinant Human Insulin Analogue) / Sanofi - LARVOL DELTA

Timing of Insulin Glargine 300 U/ML: Does It Really Matter in Terms of Efficacy and Safety at Insulin Initiation? (PubMed, Cureus) - "Timing of Gla-300 initiation, morning compared to night dosing, does not significantly impact the effectiveness in lowering the glycemic indices. Incidences of overall and nocturnal hypoglycemic events were numerically lower with morning dosing of Gla-300 compared to night dosing of Gla-300, though it was not statistically significant. An individualized approach to timing and selection of insulin therapy is essential for optimizing glycemic control and minimizing hypoglycemia risk."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Long-Term Cost-Effectiveness Analysis of Once-Weekly Insulin Icodec Versus Once-Daily Basal Insulin Analogues in Patients With Type 2 Diabetes in China (ISPOR 2025) - "Model inputs of baseline characteristics and treatment effects were derived from the ONWARDS 5 clinical trial, which compared icodec used with dosing guide app with once-daily basal insulins (glargine U100, glargine U300, and degludec). Once-weekly insulin icodec is a cost-effective treatment option compared to once-daily basal insulin analogues in China."

Clinical • Cost effectiveness • HEOR • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A cost-utility analysis of long-acting insulin analogues (detemir, glargine and degludec) for the treatment of adult type 1 diabetes in South Africa. (PubMed, Cost Eff Resour Alloc) - "The ICERs of long acting insulins were considerably higher than South Africa's indicative cost-effectiveness threshold. The status quo of NPH insulin in the management of T1DM in adults remains the most cost-effective option for the South African public health sector."

HEOR • Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

EFFECTIVENESS AND SAFETY OF INSULIN GLARGINE 300 U/ML IN ELDERLY PEOPLE WITH TYPE 2 DIABETES: AN OBSERVATIONAL STUDY (ELDERLY-T) (ATTD 2025) - "No serious adverse drug events or severe hypoglycaemia was reported (Table). Conclusions Initiating or switching to Gla-300 therapy provides a safe and effective therapeutic option for elderly people (≥75 years) living with T2D."

Clinical • Observational data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

PATIENT-REPORTED OUTCOMES (PROS) IN ELDERLY PEOPLE WITH TYPE 2 DIABETES USING INSULIN GLARGINE 300 U/ML (ELDERLY-T STUDY) (ATTD 2025) - P | "GDS-4 depression score from baseline to 6-months showed marginal improvement, with absolute mean reduction of −0.32 ± 1.2 and −0.38 ± 0.9, in BI-new and BI-switch respectively (Table). Conclusions Initiating or switching to Gla-300 therapy leads to improvements in diabetes-related quality of life, treatment satisfaction, and depression scores in elderly people with T2D."

Clinical • Patient reported outcomes • CNS Disorders • Depression • Diabetes • Geriatric Disorders • Metabolic Disorders • Psychiatry • Type 2 Diabetes Mellitus

REPORTED PREGNANCY OUTCOMES WITH INSULIN GLARGINE 300 U/ML: A POST-MARKETING SURVEY OF PHARMACOVIGILANCE DATA (ATTD 2025) - "Conclusions The rates of spontaneous abortions and congenital anomalies were low for Gla-300, and consistent with rates in the general population. The use of Gla-300 during pregnancy did not show association with specific adverse events/congenital anomalies."

Adverse events • P4 data • Diabetes • Gestational Diabetes • Hypoglycemia • Metabolic Disorders

HEALTHCARE RESOURCE UTILISATION AND CLINICAL OUTCOMES IN PEOPLE WITH TYPE 2 DIABETES SWITCHING FROM FIRST-GENERATION TO A SECOND-GENERATION BASAL INSULINS: REAL WORLD EVIDENCE (ATTD 2025) - "Background and Aims To understand the Health Care Resource Utilization (HCRU) and clinical outcomes in people in England living with type 2 diabetes mellitus (T2DM) who switched from a 1 st generation (Gen1) basal insulin (BI) to a 2 nd generation BI (glargine 300 U/mL [Gla-300] or degludec [IDeg-100]). Methods Retrospective, observational database study (Clinical Practice Research Datalink [CPRD] Aurum linked to the Hospital Episode Statistics database) in people with T2DM initiated on a Gen1 BI (e.g., glargine 100 U/mL, detemir) and switched to a 2 nd generation BI (Gla-300 or IDeg-100) (index event)...Depending on whether this was primary or secondary care recorded participants receiving Gla-300 compared to IDeg-100 experienced 58-63% (p0.001 – p=0.318) fewer diabetic ketoacidosis-related events. Conclusions In this real-world study, people with T2DM treated with Gla-300 demonstrated lower HCRU (primary care and hospitalization) compared with IDeg-100 among those..."

Clinical • Clinical data • HEOR • Real-world • Real-world evidence • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus • GEN1

DERIVED TIME-IN-RANGES IN INSULIN-NAÏVE OLDER ADULTS WITH TYPE 2 DIABETES TREATED WITH INSULIN GLARGINE 300 U/ML VS DEGLUDEC 100 U/ML: A BRIGHT TRIAL POST-HOC ANALYSIS (ATTD 2025) - P4 | "dTBR was low and at target for all groups. Conclusions In PWT2D, Gla-300 and IDeg-100 improved dTIR, reduced dTAR, without increasing dTBR in older participants (≥70 years)."

Clinical • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Analysis of patient characteristics and safety of insulin glargine U300 use in 21 359 patients with type-2 diabetes and chronic kidney disease: DPV registry study. (PubMed, Diabetes Obes Metab) - "Despite variations in patient profiles, Gla-300 is widely used across all CKD stages, particularly in advanced stages with a low rate of severe hypoglycemia, suggesting its safe administration in CKD patients."

Journal • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in individuals with type 2 diabetes by kidney function: A post hoc participant-level analysis of the ONWARDS 1-5 trials. (PubMed, Diabetes Obes Metab) - "Efficacy and hypoglycaemia outcomes of icodec versus once-daily comparators were generally consistent among adults with T2D, regardless of kidney function."

Journal • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Press Release: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025 (GlobeNewswire) - "Lantus sales were €439 million and increased by 63.4%. US sales were €193 million...Toujeo sales were €290 million and increased by 6.5%, mainly driven by Europe (+10.1%) and Rest of World (+7.4%) where Toujeo continued to increase its basal insulin market share...Alprolix sales were €169 million and increased by 19.0%, benefiting from an increase in US market share and supply sales to Sobi. Myozyme/Lumizyme sales were €132 million and decreased by 17.0% due to the aforesaid shift to exviazyme/Nexviadyme. Thymoglobulin sales were €125 million and increased by 15.2%, reflecting increased sales in the US and in Rest of World.Praluent sales were €110 million and decreased by 6.8%, reflecting lower sales in Rest of World, specifically in China."

Sales • Aplastic Anemia • Familial Hypercholesterolemia • Hemophilia A • Hemophilia B • Pompe Disease • Type 2 Diabetes Mellitus

Efficacy and safety of switching to insulin glargine 300 U/mL in people with type 2 diabetes uncontrolled on basal insulin in China: A post hoc subpopulation analysis of the INITIATION study. (PubMed, Diabetes Obes Metab) - "Gla-300 improved glycaemic control with a relatively low hypoglycaemia risk and minimal weight gain in Chinese people with T2D uncontrolled on previous BI."

Journal • Retrospective data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

AUGMENTed Real-World Data Enhances Comparative Efficacy Between Once-Weekly Insulin Icodec with Dosing Guide App Versus Once-Daily Insulin Glargine U300 in Insulin-Naive Type 2 Diabetes. (PubMed, Diabetes Ther) - P3 | "Using augmented data, the precision of the change in HbA1c estimate was increased compared with the trial stratum analysis alone. These findings help to validate the principle of utilizing augmentation to strengthen trial outcomes."

Journal • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Safety and Effectiveness of Glargine 300 U/ml After Switching from Basal Insulins in Patients with Type 1 Diabetes: COMET-T Study. (PubMed, Diabetes Ther) - "Although switching to Gla-300 in poorly controlled PwT1D did not significantly reduce TIR, it significantly decreased HbA1c values and glycemic variability without changes in BW and basal insulin dose."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Effects of insulin glargine U300 versus insulin degludec U100 on glycemic variability, hypoglycemia, and diet evaluated by continuous glucose monitoring in type 1 diabetes: a retrospective cross-sectional study. (PubMed, Kaohsiung J Med Sci) - "In this real-world study involving type 1 diabetes patients, Gla-300 appears to offer more stable glucose variability than Deg-100. Administering once-daily injections could lower the risk of hypoglycemia in the Deg-100 group and minimize GV in the Gla-300 group compared to bedtime injections."

Journal • Observational data • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

The Healthcare Resource Use Impact in Adults With Type 1 Diabetes Who Switched From a First to Another First or Next-Generation Basal Insulin Analogue: A Retrospective Linked Primary and Secondary Care Database Study in England (ISPOR-EU 2024) - "OBJECTIVES: The real-world impact of the next-generation basal insulin (Glargine U300 [Gla-300], Degludec) on healthcare resource use and mortality has previously been demonstrated in Type 2 diabetes mellitus... CPRD-HES linked data were used to compare hospitalizations and mortality in an IPTW (inverse probability of treatment weighting)-weighted set of adults with T1DM who switched from glargine 100U/mL or detemir (collectively Gen1BI) to either another Gen1BI (Gen1 cohort) or Gla-300 (Gla-300 cohort)... The results showed that a switch to Gla-300 from a Gen1BI was associated with significantly reduced healthcare resource use and decreased risk of mortality , an overall benefit for people with TIDM . For the National Health System, this switch could result in considerable cost savings and more efficient allocation of healthcare resources, ultimately enhancing the overall management of T1DM."

Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • GEN1

Comparative Cost and Saving Analysis of Insulin Glargine-300U/mL (Gla-300) vs Insulin Degludec 100 U/mL in the Treatment of Type 2 Diabetes Mellitus Based on the BRIGHT Study (ISPOR-EU 2024) - "This analysis of insulin Glargine-300U/mL in Algeria demonstrated the considerable saving on health expenses vs Insulin Degludec. This represents the potential benefit coming from the use of one insulin that demonstrates improvement of glycemic outcomes at lower cost. In conclusion, starting using the Gla-300 for the treatment of T2DM patients would lead to a relevant cost saving and minimizing the burden of diabetes management"

Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Once-Weekly Icodec Versus Basal Insulin Analogs for the Treatment of Type 2 Diabetes in the UK: A Long-Term Cost-Effectiveness Analysis Based on a Post-Hoc Analysis of the Onwards 5 Clinical Trial (ISPOR-EU 2024) - "Insulin icodec is a basal insulin analog recently developed for once-weekly administration. Icodec was projected to be a highly cost - effective treatment compared with degludec, glargine U100 and glargine U300 in the UK."

Clinical • Cost effectiveness • HEOR • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Budget Impact Model for Insulin Glargine-300U/mL (Gla-300) vs Insulin Degludec 100 U/mL in the Treatment of Type 1 Diabetes Mellitus Based on the Inrange Study (ISPOR-EU 2024) - "Results from the present study revealed that Glargine-300U/mL in Algeria reduces the costs of T1DM management. the proportion of eligible patients had considerable influence on the net financial impact. The use of Glargine-300U/mL and the overall of its clinical and economic benefit is the most rational strategy to reduce diabetes burden and its additional costs, Further studies are suggested to confirm this analysis."

HEOR • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Icodec: A Novel Once-Weekly Basal Insulin for Diabetes Management. (PubMed, Ann Pharmacother) - "Studies involving patients living with T1D or T2D on once-weekly insulin icodec compared with once-daily insulins glargine U100, glargine U300, and degludec were considered for this review. Insulin icodec once-weekly dosing could significantly improve convenience and efficacy over daily basal insulins, representing a significant innovation in insulin therapy. Insulin icodec emerges as a promising option for diabetes management, potentially improving treatment adherence and quality of life."

Journal • Review • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Effectiveness and safety of insulin glargine 300 U/mL in insulin-naïve individuals according to diabetes duration: Results from the REALI European pooled data analysis. (PubMed, Diabetes Obes Metab) - "Gla-300 was effective and safe in insulin-naïve individuals with T2D, regardless of DD. Improvement in HbA1c was greater when Gla-300 was initiated in participants with a DD of less than 4 years, although the difference between the groups was modest."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

RCT Glargine vs NPH for Treatment of DM in Pregnancy (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Loyola University

New P3 trial • Diabetes • Gestational Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

A post-hoc pooled analysis to evaluate efficacy and safety of insulin glargine 300 U/mL in insulin-naïve people with type 2 diabetes with/without prior use of glucagon-like peptide-1 receptor agonist therapy. (PubMed, Diabetes Res Clin Pract) - "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."

Journal • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of insulin glargine 300 U/mL in insulin-naive people with type 2 diabetes with/without prior use of glucagon-like peptide-1 receptor agonist therapy (EASD 2024) - "Overall, HbA1c reductions and change in FPG levels were similar after 6 months of Gla-300 treatment in people with or without prior GLP-1 RA therapy. These improvements were accompanied by a low risk of hypoglycaemia in both groups. No clinically meaningful weight changes and differences in insulin dose change were observed between groups."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Cardiopulmonary and aerobic exercise tests assessing multiple biomarkers and hormones in type 1 diabetes under different circumstances: the act-one study (EASD 2024) - P=N/A | "Materials and Adults with type 1 diabetes using multiple daily injections (MDI, insulin degludec (n=17) or glargine U300 (n=2) as basal insulin) or automated insulin delivery (AID, Medtronic 780G (n=27)) were included. In MDI participants, 80% basal dose showed more TIR than 50%. In participants using AID, temp target 30 min prior to exercise was safe to use and does not require too much planning in advance, making exercise more feasible."

Biomarker • Late-breaking abstract • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus