Basaglar (insulin glargine biosimilar) / Boehringer Ingelheim, Eli Lilly - LARVOL DELTA

Acute Dip in eGFR in Patients Treated with Tirzepatide: A Post Hoc Analysis of Long-Term Clinical Trials of Tirzepatide Treatment (KIDNEY WEEK 2025) - "The SURMOUNT-1 3-year study recruited adults with obesity or overweight and prediabetes randomized 1:1:1:1 to TZP 5:10:15mg or placebo (PBO) for 176 weeks...Conclusion These post-hoc analyses indicate a more frequent incidence of a dip in Cr-eGFR in TZP-treated (compared to iGlar-treated) participants with T2D. Furthermore, the presence of an acute dip in Cr-eGFR with TZP treatment was not associated with a more pronounced decline in kidney function."

Clinical • Late-breaking abstract • Retrospective data • Genetic Disorders • Metabolic Disorders • Obesity

Insulin Glargine Utilization and Spending Before and After the First Biosimilar Insulin Glargine: A Real-World Data Study. (PubMed, J Gen Intern Med) - "Basaglar® release was associated with spending reductions that accelerated after Semglee® availability. Biosimilar availability was associated with increases in glargine users and users per fixed-dollar amount. This study provides supportive evidence for biosimilar adoption policies."

Journal • Real-world evidence • Diabetes • Metabolic Disorders

Efficacy and safety of tirzepatide added to basal insulin in patients with type 2 diabetes in China (SURPASS-CN-INS): a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. (PubMed, Lancet Diabetes Endocrinol) - P3 | "Tirzepatide added to basal insulin improved glycaemic control and was generally well tolerated, providing evidence to support its potential therapeutic use in patients with type 2 diabetes in China."

Journal • P3 data • Diabetes • Infectious Disease • Metabolic Disorders • Respiratory Diseases • Type 2 Diabetes Mellitus

Use of Highly Concentrated U500 Insulin with Omnipod 5 in automated mode (ENDO 2025) - "In addition to the insulin she received from her pump, she also required ~140 units of subcutaneous Basaglar daily... U-500R proved to be safe and effective with Omnipod 5 AID. Further research is required to adapt the automated dosing algorithm to U-500R to reduce the risk of nocturnal hypoglycemia."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Presentation of Glucokinase-Maturity-Onset Diabetes of the Young (GCK-MODY 2) in Obesity and with Transient Autoantibodies in Children and Adolescents. (ENDO 2025) - "She was treated with Glyburide, Metformin, Basaglar, and Victoza. MODY diagnosis should be considered regardless of BMI. The presence of severe obesity in cases of GCK heterozygotes treatment with insulin sensitizers, insulin, and GLPs becomes necessary. After normalization of weight, no treatment is necessary except for weight control."

Clinical • Diabetes • Gene Therapies • Genetic Disorders • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. (PubMed, Lancet) - P3 | "Efsitora showed non-inferior HbA1c reductions and similar rates of combined clinically significant or severe hypoglycaemia versus glargine U100 in participants with type 2 diabetes treated with basal and prandial insulin. These findings show that efsitora is a well tolerated and efficacious once-weekly alternative to daily basal insulin, with a reduced injection frequency, for the treatment of adults with type 2 diabetes."

Head-to-Head • Journal • P3 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Insulin Glargine Biosimilar Prescribing and Cost Trends in the United Kingdom's Primary Care from 2020 to 2024. (PubMed, Pharmacy (Basel)) - "The introduction of biosimilars does not automatically result in altered prescribing practices, though we show that the most commonly prescribed iGlar was also the least expensive product at the end of the analysis period. At launch and for several years after, biosimilars failed to gain strong utilization, despite cost advantages, highlighting the need for active switching policies and prescriber engagement."

Journal • Diabetes • Metabolic Disorders

Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. (PubMed, N Engl J Med) - P3 | "In adults with type 2 diabetes who had not previously received insulin, once-weekly efsitora, administered in a fixed-dose regimen, was noninferior to once-daily glargine in reducing glycated hemoglobin levels. (Funded by Eli Lilly; ClinicalTrials.gov number, NCT05662332.)."

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

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

FIRST CLINICAL REPORT OF THE LILLY TEMPO PERSONALIZED DIABETES MANAGEMENT PLATFORM BOLUS CALCULATOR USE IN FREE LIVING ENVIRONMENT (ATTD 2025) - "The Lilly Tempo Smart Button enables Basaglar®, Humalog®, and Lyumjev® insulin dose-related data to automatically transfer to a compatible App. Use of the IC was consistent across all meals and corrections.Conclusions The aggregate glucose data indicates increased usage of the IC over the 6-week period corresponds to greater trust in the IC recommendations, as a significant percentage of administered doses were within 10% of the IC's suggested dose. Aggregate data indicates meaningful improvement in glycemic outcomes with the Tempo Platform IC over this period."

Clinical • Diabetes • Metabolic Disorders

What do the guidelines say about use of biosimilar insulin therapy? Simple practical considerations to guide clinicians in different patient subgroups-Sharing Canadian perspectives. (PubMed, Diabetes Obes Metab) - "This review article intends to review the efficacy and safety data from pivotal clinical trials with biosimilar insulins, as well as the regulatory and health economic considerations which underpin the safe and cost-effective use of biosimilar insulin therapy. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference. There are five biosimilar insulins currently available in Canada: insulin glargine (U-100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U-100) as the biosimilar insulin, Admelog® and insulin aspart (U-100) as the biosimilar insulins, Trurapi® and Kirsty™. Data for biosimilars must be submitted in a stepwise approach to demonstrate similarity to the reference biologic under the following categories: structure & function, human clinical trials,..."

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

Safety and Efficacy of Biosimilar Insulin Glargine (Basaglar) in Indian Patients with Type 2 Diabetes Mellitus: Results from a Multicenter, Open-Label, Single-Arm, Phase 4 Trial (ABEX). (PubMed, J Assoc Physicians India) - "Basaglar was well tolerated with few hypoglycemic events and significantly reduced HbA1c and BG from baseline in Indian insulin-naïve patients with T2DM."

Journal • P4 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

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

Impact of Introducing Basaglar Insulin to the Treatment Regimen of Youth with Diabetes in Pakistan (clinicaltrials.gov) - P4 | N=296 | Completed | Sponsor: Life for a Child Program, Diabetes Australia

HEOR • New P4 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh (clinicaltrials.gov) - P4 | N=202 | Completed | Sponsor: Life for a Child Program, Diabetes Australia

HEOR • New P4 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali (clinicaltrials.gov) - P4 | N=260 | Completed | Sponsor: Life for a Child Program, Diabetes Australia

New P4 trial • Diabetes • Metabolic Disorders • Type 1 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

Recognition of Need for Optimization of Diabetes Education for Children with Type 1 diabetes: Long term Provider Experience . (ENDO 2024) - "Case 2: The mother called at 9 pm and reported that by mistake, she did administer "Admelog" at 18 units instead of Basaglar, for her son, 11 year old with Type 1 diabetes. He was on Lantus and Humalog before... -Complications of Type 1 diabetes are preventable. The family needs further education on diabetes management including review of Insulin therapy when Insulin pump does malfunction, with a copy of written instruction of Insulin doses, differences in long and short acting Insulin along with psychosocial support to optimize care of children with Type 1 diabetes.Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Impact of Health Insurance Claims Denials in the United States: The Case of Insulin Glargine (ISPOR 2024) - "We study this phenomenon using Insulin Glargine, which has a branded version (Lantus), that began receiving competition for formulary placement from a biosimilar-like comparator (Basaglar) in 2016. Claims denials driven by non-clinical preference for certain products, likely save insurance plans money due to lower net prices they receive for these products. However, these savings must be considered relative to the disruption in care, and administrative burden put on patients and health systems."

Clinical • Reimbursement • US reimbursement • Diabetes • Diabetic Nephropathy • Genetic Disorders • Metabolic Disorders • Obesity

QWINT-4: A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (clinicaltrials.gov) - P3 | N=730 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

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

CONTINUOUS GLUCOSE MONITORING (CGM)‐BASED TITRATION OF BASAL INSULIN YIELDS SIMILAR INSULIN ADJUSTMENTS TO FASTING BLOOD GLUCOSE (FBG)‐BASED TITRATION: A RETROSPECTIVE CLINICAL ANALYSIS (ATTD 2024) - "Based on pharmacokinetic/pharmacodynamic simulations of Basaglar®, we chose the 1-hour CGM nadir (median of 3 lowest measurements) preceding the FBG timepoint for non-inferiority comparison with FBG. Dose titration was assessed using Canadian INSIGHT, AT.LANTUS, and Treat2Target standard-of-care algorithms. The probability of the dose adjustment error (CGM dose adjustment – FBG dose adjustment) being within tolerance was >90% for all 3 algorithms, with 95% confidence intervals of 0.882–0.919 (Treat2Target), 0.994–0.997 (INSIGHT), and 0.995–0.999 (AT.LANTUS)... The 1-hour CGM nadir was essentially equivalent to FBG for determining basal insulin dose by all 3 titration algorithms. Compared with traditional FBG, CGM may enable convenient collection of approximate fasting values, which may reduce the burden of self-monitoring and potentially enhance the success of basal titration."

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

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Active, not recruiting | Sponsor: Mannkind Corporation | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2024 ➔ Sep 2024

Combination therapy • Enrollment closed • Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

FROM CLINICAL DATA TO CLINICAL INSIGHTS – TRANSFORMATIVE OPPORTUNITIES FOR CLINICAL CARE USING THE LILLY TEMPO PERSONALIZED DIABETES MANAGEMENT PLATFORM: A CLINICAL TUTORIAL (ATTD 2024) - "The Lilly Tempo Smart Button™ enables Basaglar ®, Humalog®, and Lyumjev® insulin dose-related data to automatically transfer to a compatible App. The Tempo system can provide the missing information to the HCPs to transform the guess work and difficult conversations with PwDs to an opportunity for personalized and precision medical advice and better experience to the PwDs and the HCPs."

Clinical data • Diabetes • Metabolic Disorders

Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis (clinicaltrials.gov) - P2 | N=8 | Terminated | Sponsor: HealthPartners Institute | N=150 ➔ 8 | Trial completion date: Feb 2024 ➔ Feb 2023 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Feb 2023; Study intervention was adopted as standard of care.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Metabolic Disorders