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

Derived time-in-ranges in insulin-naive older adults with type 2 diabetes treated with insulin glargine 300 U/mL vs degludec 100 U/mL: a BRIGHT trial post-hoc analysis (EASD 2025) - P4 | "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

Cost effectiveness of basal insulin across age groups in France: a post-hoc analysis of an observational longitudinal study (EASD 2025) - "The results of this EF-BI post-hoc analysis suggests that overall costs, treatment adherence, and hospitalized acute events possibly related to insulin therapy favor Gla-300 over Gla-100 in the T2DM population in France, regardless of age."

Cost effectiveness • HEOR • Longitudinal study • Observational data • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Differences in the expression of insulin pathway genes according to the basal insulin analogue treatment used in the INEOX study (EASD 2025) - P4 | "So, we tried to evaluate potential differences in the gene expression of the insulin signaling pathway in leukocytes from adults with type 1 diabetes mellitus (T1DM), depending on the treatment with different long-acting basal insulin analogs, using data from the INEOX study.Materials and INEOX is a 24-week controlled clinical trial comparing two groups of T1DM patients (diagnosed over 2 years ago, treated for more than 1 year with rapid-acting insulin analogs, and with HbA1c above 10%) who were randomly assigned to treatment with Glargine U300 (Gla300) or Degludec U100 (Deg100). Our results suggest the potential differential regulation of the insulin pathway gene SOCS2 in adult women with T1DM treated with different second-generation long-acting basal insulin analogs, as differences were observed depending on the insulin analog used."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus • GAPDH • SOCS2

Aging with type 1 diabetes: a perspective on "octagenarians" living with type 1 diabetes in Italy (EASD 2025) - "Among patients treated with the conventional basal-bolus insulin regimen, most (76.5%) were treated with second-generation basal insulin (glargine U300 or degludec). The most used rapid insulin analogues were lispro (44%), aspart (32.4%), glulisine (10%), and faster aspart (11.9%)... Many people with type 1 diabetes have aged, becoming 'octogenarians' by being regularly followed up in Italian diabetes centers. The overall quality of care for patients regularly followed up has resulted in a lower-than-expected burden of end-stage renal disease, visual loss, and diabetic foot. Management of CV risk factors could be improved."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Real-World Evidence of Health Care Resource Use and Clinical Outcomes in People with Type 2 Diabetes and Impaired Renal Function Switching from First- to Second-Generation Basal Insulins in England (ADA 2025) - "To understand the health care resource use (HCRU) and clinical outcomes in patients with type 2 diabetes mellitus (T2DM) and decreased renal function (estimated glomerular filtration rate [eGFR]<60 ml/min/1.73 m2) who switched from a Gen1 BI to a Gen2 BI. In this retrospective, observational study in England, adults with T2DM who initiated treatment with a Gen1 BI (e.g., glargine 100 U/mL, detemir) and switched to a Gen2 BI (glargine 300 U/mL [Gla-300] or degludec [IDeg-100]) (index date) between 01/07/2014 and 31/03/2021 were analyzed using the Clinical Practice Research Datalink (CPRD) Aurum linked to Hospital Episode Statistics... This real-world study demonstrated that patients with T2DM and impaired renal function who switched to Gla-300 from Gen1 BI had lower HCRU among those treated with a second-generation BI."

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

CGM-Based Real-World Data on the Transition from Glargine U100 to U300 in Children and Adolescents with Type 1 Diabetes. (PubMed, Horm Metab Res) - "The study provides real-world, CGM-based evidence suggesting that glargine U300 offers a safer, more stable option for managing T1D in children, particularly in reducing hypoglycemia. These findings highlight glargine U300's potential advantages in glycemic stability, supporting its use in pediatric diabetes care."

Journal • Real-world evidence • Diabetes • Hypoglycemia • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

The impact of Insulin Degludec and Liraglutide Injection on clinical remission in patients with early - stage type 2 diabetes (ChiCTR) - P4 | N=600 | Recruiting | Sponsor: The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine; The First Affiliated Hospital of Guangxi University of Traditiona

New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Insights on Hospitalisations from the Phase 3a ONWARDS 1-6 Trials of Once-Weekly Insulin Icodec. (PubMed, Diabetes Ther) - P3 | "Similar numbers of hospitalisations were reported in both treatment arms. Icodec treatment was continued during hospitalisation in most participants and did not appear to have an impact on glycaemic management or hypoglycaemia. This analysis suggests that once-weekly icodec could be managed in a similar way to once-daily basal insulin analogues during hospitalisation."

Journal • P3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL) (clinicaltrials.gov) - P4 | N=107 | Completed | Sponsor: Mira Zuidgeest | Active, not recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Jan 2025

Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Healthcare utilization and costs in adults with type 2 diabetes treated with first or second-generation basal insulins in England. (PubMed, BMJ Open Diabetes Res Care) - "These findings suggest that Gla-300 may offer clinical and economic benefits by reducing hypoglycemia incidents and lowering healthcare costs compared with first-generation BI."

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

Necrotizing pancreatitis and diabetic ketoacidosis with untreated type 2 diabetes (DDG 2025) - "Therapy with Toujeo as basal insulin was initiated, including a comparatively stable course of metabolism... We assume a transient disruption of insulin secretion as part of acute necrotizing pancreatitis [1]. In the literature, several cases of the manifestation of type 2 diabetes with ketoacidosis in young and obese men are described [2]. In our case, there is an immediate temporal connection with the operation of a sinus pilonidalis."

Diabetes • 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

Multicenter, Phase 4 Clinical Study from India to Evaluate the Safety and Efficacy of Insulin Glargine 300 U/ml in Insulin-Naïve People with Type 2 Diabetes Uncontrolled on Oral Anti-hyperglycemic Drugs: SAFEGUARD Study. (PubMed, Diabetes Ther) - P4 | "Gla-300 was well tolerated with improved glycemic control and a low hypoglycemia risk in insulin-naïve people with T2D living in India."

Clinical • Journal • P4 data • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Type 2 Diabetes Mellitus

Primary adrenal insufficiency in a patient with type 1 diabetes (ESPE-ESE 2025) - "The patient’s medical history revealed that he was being treated with insulin glargine U300 and prandial aspart only before lunch with good glycometabolic control according to HbA1c level (HbA1c 6.8%) but he had frequent hypoglycemic episodes in the morning, 2-3 times a week...Oral hydrocortisone at 15 mg/day divided in 2 daily doses was started... Type 1 diabetes needs prompt recognition or periodical screening of potentially associated autoimmune conditions. Adrenal insufficiency even though rarely encountered among young patients, may be initially symptomless and characterized by slow progression until it turns into acute adrenal crisis, which represents a potentially life-threatening condition. Keywords: adrenal insufficiency, type 1 diabetes, Schmidt syndrome"

Clinical • Cardiovascular • Celiac Disease • Diabetes • Endocrine Disorders • Heart Failure • Hypoglycemia • Hypotension • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Pain • Renal Disease • Type 1 Diabetes Mellitus

Effects of Transition from Basal Insulin Glargine 100 U/mL to 300 U/mL on Glycemic Control in Children and Adolescents with Type 1 Diabetes - Real-World Data (ESPE-ESE 2025) - "Mean age and mean duration of diabetes was 13.14 ± 2.89, 4.71±3.26 years, respectively. The mean age at transition to Gla-300 was 12.58 ± 2.85 years. Glycemic data from the patients’ CGM is shown in Table 1."

Clinical • Real-world • Real-world evidence • Diabetes • Hypoglycemia • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Completed | Sponsor: Mannkind Corporation | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Healthcare Resource Utilization and Costs Related to Falls and Fractures Among People With Type 2 Diabetes Receiving Basal Insulin: The FRAGILE Study. (PubMed, J Health Econ Outcomes Res) - "Objective: To examine healthcare resource utilization and costs related to falls/fractures in people with type 2 diabetes treated with the longer-acting basal insulin Gla-300 (insulin glargine 300 U/mL) vs long-acting basal insulins (insulin glargine 100 U/mL or insulin detemir)/neutral protamine Hagedorn (NPH). This retrospective study of Optum's de-identified Clinformatics® Data Mart Database compared data for people aged 50 years or older with at least 1 prescription claim for basal insulin (excluding insulin degludec) between April 1, 2015, and April 30, 2021, who initiated Gla-300 insulin (basal insulin-naive) or transitioned to Gla-300 from a different basal insulin (basal insulin-switch)...Costs tended to be lower for people who switched to Gla-300; however, low event rates caused variability. The results of this study suggest that there is a positive correlation between fall/fracture events and hypoglycemia in people with type 2 diabetes and also, that..."

HEOR • Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Musculoskeletal Diseases • Orthopedics • Type 2 Diabetes Mellitus

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

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