Lantus (insulin glargine) / Sanofi - LARVOL DELTA

State Substitution Laws and Uptake of an Interchangeable Insulin Biosimilar. (PubMed, JAMA Health Forum) - "This retrospective cohort study using MarketScan commercial claims data examined fills for insulin glargine among users who were younger than 65 years and had fills for the insulin glargine Lantus (Sanofi) and its biosimilars, interchangeable insulin glargine-yfgn (Semglee [Mylan Pharmaceuticals]) and a noninterchangeable insulin glargine (Basaglar [Lilly]). Three restrictions had more pronounced associations with a lower uptake of insulin glargine-yfgn: enhanced physician notification (-8.15 pp; 95% CI, -12.49 to -3.81 pp; P < .001), refill notifications (-4.68 pp; 95% CI, -8.78 to -0.58 pp; P = .03), and patient notification (-3.52 pp; 95% CI, -8.44 to 1.40 pp; P = .16). In this cohort study, insulin users in states with less restrictive substitution laws were more likely to fill the biosimilar alternative to insulin glargine, underscoring the role of state regulations of substitution as an important determinant of biosimilar adoption and the need for reforms to..."

Journal • Retrospective data

Effect of Short-term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on 1-year Glycemic Control (clinicaltrials.gov) - P3 | N=243 | Completed | Sponsor: University of Basrah | Recruiting ➔ Completed | Phase classification: PN/A ➔ P3 | Trial completion date: May 2025 ➔ Nov 2024 | Trial primary completion date: Apr 2025 ➔ Nov 2024

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • 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

IMPACT OF REDUCED TIME TO BASAL SQ INSULIN ADMINISTRATION IN DKA PATIENTS: A PILOT (SCCM 2025) - "The basal insulin on formulary is insulin glargine, dispensed as Lantus® SQ pens...Provider and nurse satisfaction with turnaround time of SQ insulin administration has increased. Stocking insulin glargine SQ pens in ICU ADCs permitted nurses to administer basal insulin significantly sooner than previous medication delivery processes, leading to reduced time on the insulin infusion and a potential decrease in ICU length of stay for DKA patients."

Clinical • Metabolic Disorders

Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries. (PubMed, BMJ Open) - "This is the first study to show the price trend of insulin glargine and its correlation with the introduction of biosimilars, in Europe. A significant price reduction of the originator was observed after biosimilars entered the market. The median cost of biosimilars was lower than the originator, although with substantial differences between individual countries and producers."

Journal • Retrospective data

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

Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD) (clinicaltrials.gov) - P4 | N=164 | Recruiting | Sponsor: The First Affiliated Hospital of Xiamen University | Unknown status ➔ Recruiting | Trial completion date: Dec 2021 ➔ Feb 2025 | Trial primary completion date: Dec 2021 ➔ Jan 2025

Enrollment open • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

China Soli-CGM: iGlarLixi CGM Study in Chinese T2D Individuals After OADs (clinicaltrials.gov) - P4 | N=678 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Blood Glucose Management Using Insulin Glargine Lantus Versus the Biosimilar Insulin Glargineyfgn (ASHP 2024) - No abstract available

START2: Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2) (clinicaltrials.gov) - P=N/A | N=430 | Recruiting | Sponsor: Thomas Jefferson University | Not yet recruiting ➔ Recruiting | Initiation date: May 2024 ➔ Sep 2024

Enrollment open • Trial initiation date • Diabetes • Gestational Diabetes • Metabolic Disorders

START 1: Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (clinicaltrials.gov) - P=N/A | N=430 | Recruiting | Sponsor: Thomas Jefferson University | Not yet recruiting ➔ Recruiting | Initiation date: May 2024 ➔ Sep 2024

Enrollment open • Trial initiation date • Diabetes • Gestational Diabetes • Metabolic Disorders

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus® (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Xentria, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

China Soli-CGM: iGlarLixi CGM Study in Chinese T2D Individuals After OADs (clinicaltrials.gov) - P4 | N=678 | Not yet recruiting | Sponsor: Sanofi

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

A Case of Rare Polymicrobial Quadruple Zoonotic Peritonitis in a Patient on Continuous Cycling PeritonealDialysis (CCPD) (KIDNEY WEEK 2024) - "Past medical history was relevant for kidney disease due to MGN status post cyclophosphamide and steroids and prostate cancer status post-prostatectomy...He was empirically treated with IP vancomycin and gentamicin for peritonitis...PD culture from first clinic visit had very slow growth and eventually turned out to be positive for Neisseria shayeganii, Paenibacillus glucanolyticuls/lantus, Cutibacterium(propionibacterium) acnes and Capnocytophaga species. He received IP vancomycin, oral ciprofloxacin, fluconazole and later switched to IV piperacillin-tazobactam for 7 days. His symptoms improved and he was discharged with amoxicillin and clavulanate for 3 weeks...Decision was made to remove PD catheter and transfer to HD. We presented an uncommon case of PD related peritonitis with polymicrobial rare zoonotic organisms. We believe this case can help enhance clinician awareness and understanding of Neisseria Shayeganii and other zoonotic-related peritonitis."

Clinical • Cardiovascular • Chronic Kidney Disease • Genito-urinary Cancer • Hypotension • Infectious Disease • Nephrology • Oncology • Pain • Prostate Cancer • Renal Disease • Septic Shock • Solid Tumor

MYOPATHY LEADING TO RHABDOMYOLYSIS AS A RARE SIDE EFFECT OF LENVATINIB AND PEMBROLUZIMAB THERAPY (CHEST 2024) - "Myositis and rhabdomyolysis have also been reported in the literature as a rare side effect in anti-PDL-1 drugs, such as pembrolizumab, and anti-CTLA-4 drugs, such as ipilimumab.[3,4] One proposed mechanism to this process is new autoimmune hypothyroidism leading to rhabdomyolysis.[5] In patients who are on both TKI's and ICI's, it may be difficult to discern the instigating agent as illustrated in this case report...Prior to admission, she was taking amlodipine, diazepam, glipizide, Lantus, levothyroxine, lisinopril-hydrochlorothiazide, metformin, rosuvastatin, pembrolizumab, and lenvatinib for several months... Serial CK levels can be useful in patients presenting to the clinic with muscle pain or weakness.7 Routine screening for musculoskeletal symptoms in patients on TKI's and ICI's should be a part of regular follow up."

Adverse events • Cardiovascular • Diabetes • Dyslipidemia • Endocrine Disorders • Endometrial Cancer • Fatigue • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypertension • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Myositis • Oncology • Pain • Psychiatry • Solid Tumor • Type 1 Diabetes Mellitus

SGLTI-INDUCED EDKA: A COMMON ADVERSE REACTION WITH AN UNPREDICTABLE COURSE (CHEST 2024) - "On day 1 of intubation, acidosis improved, anion gap was closed, and the patient was switched from insulin drip to Lantus; however, after 2 days of intubation, the patient had a 10 second pause on telemetry, likely given a worsening acidosis... Although this patient had a favorable outcome, it is important to document cases as SGLT2 inhibitors become guideline therapy for various mainstem treatments. With the understanding of the side effect, it can lead to better patient management and expectations when treating this condition."

CNS Disorders • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Vascular Neurology

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus® (clinicaltrials.gov) - P1 | N=114 | Not yet recruiting | Sponsor: Xentria, Inc.

New P1 trial

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

Insulin therapy DE-intensificAtion with iGlarLixi: the IDEAL randomised controlled trial (EASD 2024) - P4 | "Eligible individuals (age 18-80 years, total daily dose of insulin [TDD] ≤ 0.8 IU/kg and fasting c-peptide above the lower limit of normal) on MDI regimen and a background therapy with metformin ± sodium-glucose co-transporter 2 inhibitor were randomised in a 1:1 fashion into once-daily administered iGlarLixi or continuation with MDI regimen, both titrated to fasting plasma glucose (FPG) ≤ 6 mmol/L (108 mg/dL)... Insulin therapy de-intensification from MDI regimen into once-daily administered iGlarLixi is an efficient and safe treatment option for PwT2D that provides comparable glycaemic control with the benefits of reduction of BW, TDD, number of insulin injections and lower proportion of visits as which hypoglycaemia was reported."

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

Soli-switch: efficacy and safety of switching to iGlarLixi from premixed insulins in people with type 2 diabetes (EASD 2024) - P4 | "Switching from PI to iGlarLixi offered a simplified treatment option, with improved glycemic outcomes in people with T2D, with added weight benefits and low risk of clinically relevant hypoglycemia."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • 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

Efficacy and safety of iGlarLixi vs IDegAsp in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drug(s): the SoliD randomised controlled trial (EASD 2024) - P3 | "Background and aims: SoliD compared the efficacy and safety of iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide, vs insulin degludec + insulin aspart (IDegAsp) in Chinese people with T2D suboptimally controlled with oral antidiabetic drug(s) (OAD). Materials and In this 24-week, multicentre, open-label, phase 3 study, insulin-naïve people with HbA 1c 7-11% were randomised 1:1 to once-daily iGlarLixi (n=291) or IDegAsp (n=291), with continued metformin ± sodium-glucose co-transporter-2 inhibitors... In Chinese people with T2D, suboptimally controlled on OAD(s), iGlarLixi achieved superior improvements in glycaemic control, prevention of BW gain and a lower hypoglycaemic event rate vs IDegAsp"

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

Considerations for practical use of tree-based scan statistics for signal detection using electronic healthcare data: a case study with insulin glargine. (PubMed, Expert Opin Drug Saf) - "Using the anti-diabetes drug insulin glargine (Lantus®) we apply two different tree-based scan designs using TreeScan™ software on retrospective EHD and compare the results to one another as well as to results from a disproportionality analysis using SRD...Differences in detected alerts between TBSS methods and between TBSS and disproportionality analysis of SRD are likely attributable to differences in data, comparator, and study design. Our results suggest that HFDS methods like TBSS applied to EHD may complement more traditional approaches such as disproportionality analysis of SRD to provide a more complete picture of product safety in the post-approval setting."

Journal • Diabetes • Metabolic Disorders

Press Release: Sanofi Q2 - strong performance with 10% sales growth; 2024 guidance upgraded (GlobeNewswire) - "Sarclisa (multiple myeloma) sales were €121 million and increased by 36.2%, driven by strong growth in the US and the Rest of World, specifically Japan. Rezurock (chronic graft-versus-host disease) sales were €114 million and increased by 52.7%, driven by improved patient adherence and new patients, primarily in the US and new launches in China and the UK...Tzield (delay onset of type 1 diabetes) sales were €11 million, a sequential increase from Q1 2024 of c.10%...Lantus sales were €398 million and increased by 21.0%. In the US, sales increased by 225.0% to €158 million...Toujeo sales were €313 million and increased by 11.0%, mainly driven by Europe and China."

Sales • Diabetes • Graft versus Host Disease • Immunology • Multiple Myeloma • Type 1 Diabetes Mellitus

Assessment of subcutaneously administered insulins using in vitro release cartridge: Medium composition and albumin binding. (PubMed, Int J Pharm) - "Drug disappearance was assessed for solution, suspension and in situ precipitating insulin products (Actrapid, Levemir, Tresiba, Mixtard 30, Insulatard, Lantus) using the flow-based cartridge. Albumin-binding acylated insulin analogs exhibited rapid disappearance from the cartridge; however, sustained retention was achieved by coupling albumin to the matrix. An in vitro-in vivorelation was established for the non-albumin-binding insulins.The IVR cartridge is flexible with potential in formulation development as shown by the ability to accommodate solutions, suspensions, and in situ forming formulations while tailoring of the system to probe in vivo relevant medium effects and tissue constituent interactions."

Journal • Preclinical