Lantus (insulin glargine) / Sanofi - LARVOL DELTA

Unique Case of an 11-Year-Old Boy With Donohue Syndrome (ENDO 2025) - "He did not respond to high-dose Lantus... We report a rare presentation of Donohue Syndrome in a male patient, illustrating the early onset of severe hyperinsulinemia as well as the dysmorphic facial characteristics, hepatomegaly, and significant growth restriction. Genetic testing confirmed a pathogenic INSR mutation. Management focused on strict monitoring of glucose levels and a specialized diet."

Clinical • Dermatology • Developmental Disorders • Diabetes • Gynecology • Hepatology • IR

Navigating the Uncertainty: Atypical Diabetes Mellitus with Negative Biomarkers and Complex Management (ENDO 2025) - "He was discharged with insulin (Lantus 8 units and Novolog 2 units TID) and metformin (METF) 1000 mg BID.Two weeks later when he was evaluated in clinic he was only taking METF with small doses of short-acting insulin, as needed...Patient was trialed with acarbose with no effect on BG, then a dipeptidyl peptidase-4 (DDP-4) inhibitor... This case highlights the complexity involved in diagnosing and managing atypical forms of DM, including LADA, monogenic, and ketosis-prone DM. It is a spectrum, which may present with features of both type 1 and type 2 DM but lacks definitive biomarkers. Clinicians should consider the atypical forms in adult patients with new-onset diabetes and atypical presentations, especially when there is an absence of typical autoimmune markers."

Biomarker • Diabetes • Diabetic Retinopathy • Fatigue • Hypoglycemia • Immunology • Metabolic Disorders • Renal Disease • Retinal Disorders • Type 1 Diabetes Mellitus

Post-marketing safety of Lantus and its interchangeable biosimilar Semglee in the United States: A disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) database. (PubMed, Diabetes Obes Metab) - "Findings identified significant post-marketing safety signals of Lantus and Semglee. Longitudinal studies are warranted to verify these signals."

Adverse events • Journal • P4 data • Diabetes • Hypoglycemia • Lipodystrophy • Metabolic Disorders

Post-surgical biliary pancreatitis and GAD positive diabetes: a rare case of Type 3c DM with Autoimmune features (ESPE-ESE 2025) - "Pain control due to opioid intolerance (hallucinations on morphine and nausea with oxycodone) required PCA fentanyl 20 mcg bolus, paracetamol, and diclofenac supplement...The patient was managed with basal-bolus insulin (Lantus 28 units nightly, Novorapid 8-14 units per meal ) and sliding scale correction for blood glucose 10 mmol/L. The patient was discharged with a management plan of Creon 250,000 units and Humalog 12-20 units with a meal. Tresiba long-acting double strength 84 units at night... This is an atypical instance of type 3c diabetes accompanied by post-surgical pancreatitis, biliary blockage, and a rapid onset of GAD-positive diabetes. Acute pancreatitis has been known to elevate GAD-antibody levels, which can result in insulin-dependent diabetes. The presented case is rare as GAD antibody levels are typically lower in autoimmune diabetes (less than 100 U/ML)."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Diabetes • Fatigue • Gastroenterology • Hepatology • Immunology • Insomnia • Metabolic Disorders • Pain • Pancreatitis • Pulmonary Disease • Respiratory Diseases • Sleep Disorder • 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

Pharmacokinetics, Pharmacodynamics, and Bioequivalence of Test Insulin Glargine Versus Reference Preparation (Lantus®) in Healthy Male Volunteers-By Euglycemic Clamp Technique. (PubMed, Pharmaceutics) - "There was no clinically significant adverse reaction observed during the experiment. The glucose clamp has been established and bioequivalence between test preparation and reference preparation has been demonstrated."

Journal • PK/PD data • Diabetes • Metabolic Disorders

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